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CompletedNCT04647383Updated Oct 10, 2023Results posted

A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease

A Phase 1 interventional study of Placebo and Lemborexant 10 mg in Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive and Respiration Disorders, sponsored by Eisai Inc.. Completed at 11 sites in United States. Open to participants aged 45 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by Eisai Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
45 Years to 90 Years
Sex
All
01

Study summary

The primary purpose of the study is to determine whether lemborexant increases the apnea hypopnea index (AHI) on Day 8 of treatment in adult and elderly participants (adults greater than or equal to [>=] 45 to less than [\<] 65 years; elderly >=65 to 90 years) with moderate to severe obstructive sleep apnea (OSA) compared with placebo, and using pulse oximetry determine whether lemborexant decreases the peripheral oxygen saturation (SpO2) during total sleep time (TST) on Day 8 of treatment in adult and elderly participants (adults >=45 to \<65 years; elderly >=65 to 90 years) with moderate to severe chronic obstructive pulmonary disease (COPD) compared with placebo.

02

Conditions studied

  • Sleep Apnea, Obstructive
  • Pulmonary Disease, Chronic Obstructive
  • Respiration Disorders

Keywords

  • E2006
  • Lemborexant
  • Peripheral Oxygen Saturation
  • Apnea Hypopnea Index
03

In context

Sleep Apnea, Obstructive

2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.

This study's enrollment of 63 is above the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Eisai Inc. is the lead sponsor of 368 studies on the registry; 7 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 56 (67%) have results posted.

Browse Eisai Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female, age >=45 and \<=90 at the time of informed consent
  2. Voluntary agreement and ability to provide written informed consent
  3. Body mass index (BMI) \<40 Kilogram per meter square (kg/m\^2)
  4. Reports habitually sleeping for at least 5.5 hours per night
  5. Reports habitual bedtime between 21:00 and midnight
  6. Agrees to stay in bed for 7 hours per night for the duration of the study
  7. At Screening Visit 2: Has completed the sleep diary for at least 5 consecutive nights

  8. At Screening Visit 2: Confirmation of mean habitual bedtime (MHB) between 21:00 and midnight (sleep diary)

    Additional Inclusion Criteria (OSA Cohort)

  9. Moderate to severe OSA diagnosed according to the criteria of the ICSD, confirmed by PSG (home sleep testing by portable monitor is acceptable) within the previous 5 years or a repeated PSG during screening
  10. On screening PSG: moderate OSA (defined as 15 \<=AHI \<30) or severe OSA (defined as AHI >=30 per hour)

  11. SpO2 >=94% assessed as part of vital signs at Screening Visit 1

    Additional Inclusion Criteria (COPD Cohort)

  12. Screening spirometry performed as per the Global Initiative for Obstructive Lung Disease (GOLD) recommendations

  13. On screening spirometry, based on post-bronchodilator Forced Expiratory Volume in 1 second (FEV1):

    • FEV1/Forced Vital Capacity (FVC) \<0.70 and one of the following:
    • 50% \<=FEV1 \<80% predicted (GOLD 2 Classification for moderate COPD) or
    • 30% \<=FEV1 \<50% predicted (GOLD 3 Classification for severe COPD)
  14. Moderate to severe COPD according to medical history and screening spirometry as per the GOLD criteria (GOLD 2019)

  15. On screening PSG

    • AHI \<15
    • SpO2 during wakefulness >90% (both supine and sitting)
    • SpO2 during sleep >=80% for at least 75% of the recording period with no more than five continuous minutes \<80% and with no SpO2 readings \<70%

Exclusion criteria

Exclusion Criteria:

  1. Females of childbearing potential
  2. A current diagnosis of restless legs syndrome, periodic limb movement disorder, circadian rhythm sleep disorder, or narcolepsy
  3. Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicate the need for referral for a diagnostic evaluation for the presence of narcolepsy
  4. A history of symptoms of rapid eye movement (REM) Behavior Disorder, sleep-related violent behavior, sleep-driving, or sleep-eating, or symptoms of another parasomnia that in the investigator's opinion make the participant unsuitable for the study

  5. Periodic Limb Movement with Arousal Index (PLMAI) as measured on the screening

    PSG:

    • Age 18 to \<65 years: PLMAI >=10
    • Age >65 years: PLMAI >15
  6. A prolonged QT interval by Fredericia (QTcF) (QTcF >450 milliseconds [ms]) as demonstrated by a repeated electrocardiogram (ECG) at Screening
  7. Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening (that is, answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale [C-SSRS])
  8. Any lifetime suicidal behavior (per the Suicidal Behavior section of the C-SSRS) within 10 years of Screening
  9. Evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
  10. Hypersensitivity to the study drug or any of the excipients
  11. Used any prohibited prescription or over-the-counter medications within 1 week or 5 half-lives, whichever is longer, before the screening PSG
  12. Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the study
  13. Scheduled for surgery during the study that requires general anesthesia or administration of prohibited medications
  14. Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics or prior suicide attempt(s) within approximately the last 2 years
  15. History of drug or alcohol dependency or abuse within approximately the last 2 years
  16. Use of illegal recreational drugs (includes marijuana, regardless of whether prescribed for medicinal use)
  17. Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5*the half-life, whichever is longer preceding informed consent
  18. Previously participated in other clinical trial of lemborexant

  19. Exposure within the last 14 days to an individual with confirmed or probable corona virus disease 2019 (COVID-19) or symptoms within the last 14 days that are on the most recent Centers for Disease Control and Prevention (CDC) list of COVID symptoms or any other reason to consider the participant at potential risk for an acute COVID-19 infection

    Additional Exclusion Criteria (OSA Cohort)

  20. SpO2 \<80% for >=5% of TST during the screening PSG
  21. Use of a continuous positive airway pressure (CPAP) device or dental appliance within 2 weeks of the screening PSG, and does not agree to abstain from the use of a CPAP device or dental appliance from the
  22. Current evidence of a clinically significant, active respiratory disorder other than OSA. This includes bronchiectasis, emphysema, asthma, COPD or any other pulmonary disorder identified by review of medical history, physical examination, and which in the opinion of the investigator, could compromise the participant's safety or interfere with study assessments

  23. Current evidence of other clinically significant disease (example, psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, cardiovascular system, or a congenital abnormality), malignancy within the past 5 years (other than adequately treated basal cell carcinoma or in situ carcinoma of the cervix), or chronic pain that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments. Screening Visit through the last study visit

    Additional Exclusion Criteria (COPD Cohort)

  24. Use of continuous (>16 hours/day) oxygen therapy
  25. Use of oxygen therapy during PSG
  26. Determination that, in the opinion of the investigator, removal of oxygen therapy could affect the participant's safety or interfere with the study assessments
  27. Recent changes to COPD medications or recent acute exacerbation of COPD (that is, needing hospitalization or treatment with oral corticosteroids and/or antibiotics) within 3 months of enrollment

  28. On screening spirometry (COPD only):

    • FEV1/FVC >=0.70
    • FEV1 >=80% predicted (GOLD 1 Classification for mild COPD)
    • FEV1 \<30% predicted (GOLD 4 Classification for very severe COPD)

  29. On screening PSG (COPD only):

    • Moderate to severe OSA (AHI >=15)
    • SpO2 \<90% during wakefulness (supine and sitting)
    • SpO2 during sleep \<80% for 25% or more of the recording with >5 consecutive minutes \<80% and any SpO2 reading \<70%
  30. ECG evidence of right ventricular hypertrophy or right heart failure
  31. Screening hematocrit >55%
  32. Use of a CPAP device or dental appliance within 2 weeks of the screening PSG, and does not agree to abstain from the use of a CPAP device or dental appliance from the Screening Visit through the last study visit
  33. Current evidence of a clinically significant, active respiratory disorder other than COPD and mild OSA. This includes any other pulmonary disorder identified by review of medical history, physical examination, and which in the opinion of the investigator, could compromise the participant's safety or interfere with study assessments.
  34. Current evidence of other clinically significant disease other than COPD and mild OSA (example, psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, cardiovascular system, or a congenital abnormality), malignancy within the past 5 years (other than adequately treated basal cell carcinoma or in situ carcinoma of the cervix), or chronic pain that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    OSA Cohort, Sequence A: Placebo + Lemborexant 10 mg

    Participants with OSA will receive one lemborexant-matched placebo tablet on the night of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant 10 mg tablet on the night of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days will be maintained between the 2 treatment periods.

    Drug: Placebo · Drug: Lemborexant 10 mg

  • Experimental
    OSA Cohort, Sequence B: Lemborexant 10 mg + Placebo

    Participants with OSA will receive one lemborexant 10 mg tablet on the night of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant-matched placebo tablet on the night of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days will be maintained between the 2 treatment periods.

    Drug: Placebo · Drug: Lemborexant 10 mg

  • Experimental
    COPD Cohort, Sequence C: Placebo + Lemborexant 10 mg

    Participants with COPD will receive one lemborexant-matched placebo tablet on the night of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant 10 mg tablet on the night of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days will be maintained between the 2 treatment periods.

    Drug: Placebo · Drug: Lemborexant 10 mg

  • Experimental
    COPD Cohort, Sequence D: Lemborexant 10 mg + Placebo

    Participants with COPD will receive one lemborexant 10 mg tablet on the night of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant-matched placebo tablet on the night of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days will be maintained between the 2 treatment periods.

    Drug: Placebo · Drug: Lemborexant 10 mg

Interventions

  • DrugPlacebo

    OSA: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.

    Also known as: E2006

  • DrugLemborexant 10 mg

    OSA: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.

    Also known as: E2006

  • DrugPlacebo

    COPD: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.

    Also known as: E2006

  • DrugLemborexant 10 mg

    COPD: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.

    Also known as: E2006

06

What researchers measure

Primary outcomes

  1. OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Periods 1 and 2

    AHI was the number of apneas and hypopneas divided by the total sleep time (TST) (in minutes) and multiplied by 60 (minute per hour \[min/hour\]) (that is, the average number of apneas and hypopneas per hour of sleep), as defined by the American Academy of Sleep Medicine. An AHI greater than or equal to (\>=) 5 to less than (\<) 15 is classed as mild, AHI \>=15 to \<30 as moderate, and AHI \>=30 as severe. TST was defined as the total time asleep in minutes using polysomnography (PSG).

    Time frame: Day 8 of Treatment Periods 1 and 2 (up to Day 30)

  2. COPD Cohort: Peripheral Oxygen Saturation (SpO2) During TST on Day 8 of Treatment Periods 1 and 2

    SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.

    Time frame: Day 8 of Treatment Periods 1 and 2 (up to Day 30)

Secondary outcomes

  1. OSA Cohort: AHI on Day 1 of Treatment Periods 1 and 2

    AHI was the number of apneas and hypopneas divided by the TST (in minutes) and multiplied by 60 (min/hour) (that is, the average number of apneas and hypopneas per hour of sleep), as defined by the American Academy of Sleep Medicine. An AHI \>=5 to \<15 is classed as mild, \>=15 to \<30 as moderate, and AHI \>=30 as severe. TST was defined as the total time asleep in minutes using PSG.

    Time frame: Day 1 of Treatment Periods 1 and 2 (up to Day 23)

  2. OSA Cohort: Peripheral SpO2 During TST on Days 1 and 8 of Treatment Periods 1 and 2

    SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.

    Time frame: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)

  3. OSA Cohort: Percentage (%) of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2

    TST was defined as the total time asleep in minutes using PSG. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.

    Time frame: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)

  4. OSA Cohort: Mean Oxygen Desaturation Index (ODI) on Days 1 and 8 of Treatment Periods 1 and 2

    ODI was defined as (oxygen desaturations \>=3%\*60)/TST (that is, the average number of oxygen desaturations \>=3% per hour of sleep), as defined by the American Academy of Sleep Medicine. TST was defined as the total time asleep in minutes using PSG.

    Time frame: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)

  5. OSA Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2

    Desaturation was defined as decrease in the mean SpO2 of \>=3% (over the last 120 seconds) that lasts for at least 10 seconds. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.

    Time frame: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)

  6. COPD Cohort: Peripheral SpO2 During TST on Day 1 of Treatment Periods 1 and 2

    SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.

    Time frame: Day 1 of Treatment Periods 1 and 2 (up to Day 23)

  7. COPD Cohort: AHI on Days 1 and 8 of Treatment Periods 1 and 2

    AHI was the number of apneas and hypopneas divided by the TST (in minutes) and multiplied by 60 (min/hour) (that is, the average number of apneas and hypopneas per hour of sleep), as defined by the American Academy of Sleep Medicine. An AHI \>=5 to \<15 is classed as mild, \>=15 to \<30 as moderate, and AHI \>=30 as severe. TST was defined as the total time asleep in minutes using PSG.

    Time frame: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)

  8. COPD Cohort: Percentage of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2

    TST was defined as the total time asleep in minutes using PSG. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.

    Time frame: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)

  9. COPD Cohort: Mean ODI on Days 1 and 8 of Treatment Periods 1 and 2

    ODI was defined as (oxygen desaturations \>=3%\*60)/TST (that is, the average number of oxygen desaturations \>=3% per hour of sleep), as defined by the American Academy of Sleep Medicine. TST was defined as the total time asleep in minutes using PSG.

    Time frame: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)

  10. COPD Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2

    Desaturation was defined as decrease in the mean SpO2 of \>=3% (over the last 120 seconds) that lasts for at least 10 seconds. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.

    Time frame: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)

07

Results

Posted Oct 10, 2023

Participant flow

Participants took part in the study at 10 investigative sites in the United States from 06 January 2021 to 10 February 2022.

Treatment Period 1 (8 Days)
Participant flow — Treatment Period 1 (8 Days)
MilestoneOSA Cohort, Sequence A: Placebo + Lemborexant 10 mgOSA Cohort, Sequence B: Lemborexant 10 mg + PlaceboCOPD Cohort, Sequence C: Placebo + Lemborexant 10 mgCOPD Cohort, Sequence D: Lemborexant 10 mg + Placebo
Started16171416
Completed16171416
Not completed0000
Washout Period (14 Days)
Participant flow — Washout Period (14 Days)
MilestoneOSA Cohort, Sequence A: Placebo + Lemborexant 10 mgOSA Cohort, Sequence B: Lemborexant 10 mg + PlaceboCOPD Cohort, Sequence C: Placebo + Lemborexant 10 mgCOPD Cohort, Sequence D: Lemborexant 10 mg + Placebo
Started16171416
Completed16171416
Not completed0000
Treatment Period 2 (8 Days)
Participant flow — Treatment Period 2 (8 Days)
MilestoneOSA Cohort, Sequence A: Placebo + Lemborexant 10 mgOSA Cohort, Sequence B: Lemborexant 10 mg + PlaceboCOPD Cohort, Sequence C: Placebo + Lemborexant 10 mgCOPD Cohort, Sequence D: Lemborexant 10 mg + Placebo
Started16171416
Completed16161416
Not completed0100
Withdrew: Adverse event0100

Outcome measures

PrimaryOSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Periods 1 and 2

AHI was the number of apneas and hypopneas divided by the total sleep time (TST) (in minutes) and multiplied by 60 (minute per hour \[min/hour\]) (that is, the average number of apneas and hypopneas per hour of sleep), as defined by the American Academy of Sleep Medicine. An AHI greater than or equal to (\>=) 5 to less than (\<) 15 is classed as mild, AHI \>=15 to \<30 as moderate, and AHI \>=30 as severe. TST was defined as the total time asleep in minutes using polysomnography (PSG).

Time frame:
Day 8 of Treatment Periods 1 and 2 (up to Day 30)
Reported as:
Mean · events (apnea plus hyponea) per hour
OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Periods 1 and 2
events (apnea plus hyponea) per hourOSA Cohort: PlaceboOSA Cohort: Lemborexant 10 mg
OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Periods 1 and 245.09 ± 22.85144.90 ± 22.246
PrimaryCOPD Cohort: Peripheral Oxygen Saturation (SpO2) During TST on Day 8 of Treatment Periods 1 and 2

SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.

Time frame:
Day 8 of Treatment Periods 1 and 2 (up to Day 30)
Reported as:
Mean · percentage of oxygen saturation
COPD Cohort: Peripheral Oxygen Saturation (SpO2) During TST on Day 8 of Treatment Periods 1 and 2
percentage of oxygen saturationCOPD Cohort: PlaceboCOPD Cohort: Lemborexant 10 mg
COPD Cohort: Peripheral Oxygen Saturation (SpO2) During TST on Day 8 of Treatment Periods 1 and 290.80 ± 2.56591.27 ± 2.227
SecondaryOSA Cohort: AHI on Day 1 of Treatment Periods 1 and 2

AHI was the number of apneas and hypopneas divided by the TST (in minutes) and multiplied by 60 (min/hour) (that is, the average number of apneas and hypopneas per hour of sleep), as defined by the American Academy of Sleep Medicine. An AHI \>=5 to \<15 is classed as mild, \>=15 to \<30 as moderate, and AHI \>=30 as severe. TST was defined as the total time asleep in minutes using PSG.

Time frame:
Day 1 of Treatment Periods 1 and 2 (up to Day 23)
Reported as:
Mean · events (apnea plus hyponea) per hour
OSA Cohort: AHI on Day 1 of Treatment Periods 1 and 2
events (apnea plus hyponea) per hourOSA Cohort: PlaceboOSA Cohort: Lemborexant 10 mg
OSA Cohort: AHI on Day 1 of Treatment Periods 1 and 244.65 ± 25.77041.64 ± 21.215
SecondaryOSA Cohort: Peripheral SpO2 During TST on Days 1 and 8 of Treatment Periods 1 and 2

SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.

Time frame:
Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)
Reported as:
Mean · percentage of oxygen saturation
OSA Cohort: Peripheral SpO2 During TST on Days 1 and 8 of Treatment Periods 1 and 2
percentage of oxygen saturationOSA Cohort: PlaceboOSA Cohort: Lemborexant 10 mg
Day 193.12 ± 2.07393.00 ± 2.462
Day 893.44 ± 1.98393.06 ± 1.983
SecondaryOSA Cohort: Percentage (%) of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2

TST was defined as the total time asleep in minutes using PSG. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.

Time frame:
Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)
Reported as:
Mean · percentage of TST
OSA Cohort: Percentage (%) of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2
percentage of TSTOSA Cohort: PlaceboOSA Cohort: Lemborexant 10 mg
Day 1: SpO2 <90%11.966 ± 16.894112.849 ± 15.5993
Day 1: SpO2 <85%2.708 ± 4.94003.748 ± 6.6010
Day 1: SpO2 <80%0.776 ± 1.78961.125 ± 2.5021
Day 8: SpO2 <90%9.474 ± 9.793011.295 ± 12.6345
Day 8: SpO2 <85%2.283 ± 3.63022.696 ± 4.4283
Day 8: SpO2 <80%0.522 ± 1.33450.651 ± 1.3153
SecondaryOSA Cohort: Mean Oxygen Desaturation Index (ODI) on Days 1 and 8 of Treatment Periods 1 and 2

ODI was defined as (oxygen desaturations \>=3%\*60)/TST (that is, the average number of oxygen desaturations \>=3% per hour of sleep), as defined by the American Academy of Sleep Medicine. TST was defined as the total time asleep in minutes using PSG.

Time frame:
Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)
Reported as:
Mean · events per hour
OSA Cohort: Mean Oxygen Desaturation Index (ODI) on Days 1 and 8 of Treatment Periods 1 and 2
events per hourOSA Cohort: PlaceboOSA Cohort: Lemborexant 10 mg
Day 139.71 ± 24.54736.52 ± 20.325
Day 839.07 ± 21.47539.51 ± 22.037
SecondaryOSA Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2

Desaturation was defined as decrease in the mean SpO2 of \>=3% (over the last 120 seconds) that lasts for at least 10 seconds. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.

Time frame:
Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)
Reported as:
Mean · events (number of desaturations)
OSA Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2
events (number of desaturations)OSA Cohort: PlaceboOSA Cohort: Lemborexant 10 mg
Day 1253.85 ± 161.971256.52 ± 141.952
Day 8255.28 ± 149.158273.97 ± 155.209
SecondaryCOPD Cohort: Peripheral SpO2 During TST on Day 1 of Treatment Periods 1 and 2

SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.

Time frame:
Day 1 of Treatment Periods 1 and 2 (up to Day 23)
Reported as:
Mean · percentage of oxygen saturation
COPD Cohort: Peripheral SpO2 During TST on Day 1 of Treatment Periods 1 and 2
percentage of oxygen saturationCOPD Cohort: PlaceboCOPD Cohort: Lemborexant 10 mg
COPD Cohort: Peripheral SpO2 During TST on Day 1 of Treatment Periods 1 and 291.53 ± 2.16191.13 ± 2.801
SecondaryCOPD Cohort: AHI on Days 1 and 8 of Treatment Periods 1 and 2

AHI was the number of apneas and hypopneas divided by the TST (in minutes) and multiplied by 60 (min/hour) (that is, the average number of apneas and hypopneas per hour of sleep), as defined by the American Academy of Sleep Medicine. An AHI \>=5 to \<15 is classed as mild, \>=15 to \<30 as moderate, and AHI \>=30 as severe. TST was defined as the total time asleep in minutes using PSG.

Time frame:
Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)
Reported as:
Mean · events (apnea plus hyponea) per hour
COPD Cohort: AHI on Days 1 and 8 of Treatment Periods 1 and 2
events (apnea plus hyponea) per hourCOPD Cohort: PlaceboCOPD Cohort: Lemborexant 10 mg
Day 16.09 ± 4.8277.40 ± 6.331
Day 85.88 ± 5.2456.15 ± 5.185
SecondaryCOPD Cohort: Percentage of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2

TST was defined as the total time asleep in minutes using PSG. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.

Time frame:
Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)
Reported as:
Mean · percentage of TST
COPD Cohort: Percentage of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2
percentage of TSTCOPD Cohort: PlaceboCOPD Cohort: Lemborexant 10 mg
Day 1: SpO2 <90%15.593 ± 23.355221.468 ± 30.0042
Day 1: SpO2 <85%0.860 ± 1.92863.286 ± 9.0190
Day 1: SpO2 <80%0.155 ± 0.54160.224 ± 0.5912
Day 8: SpO2 <90%22.991 ± 30.959521.086 ± 30.3560
Day 8: SpO2 <85%3.330 ± 9.99351.151 ± 3.1124
Day 8: SpO2 <80%0.152 ± 0.47430.075 ± 0.2218
SecondaryCOPD Cohort: Mean ODI on Days 1 and 8 of Treatment Periods 1 and 2

ODI was defined as (oxygen desaturations \>=3%\*60)/TST (that is, the average number of oxygen desaturations \>=3% per hour of sleep), as defined by the American Academy of Sleep Medicine. TST was defined as the total time asleep in minutes using PSG.

Time frame:
Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)
Reported as:
Mean · events per hour
COPD Cohort: Mean ODI on Days 1 and 8 of Treatment Periods 1 and 2
events per hourCOPD Cohort: PlaceboCOPD Cohort: Lemborexant 10 mg
Day 14.61 ± 4.4625.46 ± 4.823
Day 84.34 ± 4.5624.71 ± 4.772
SecondaryCOPD Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2

Desaturation was defined as decrease in the mean SpO2 of \>=3% (over the last 120 seconds) that lasts for at least 10 seconds. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.

Time frame:
Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)
Reported as:
Mean · events (number of desaturations)
COPD Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2
events (number of desaturations)COPD Cohort: PlaceboCOPD Cohort: Lemborexant 10 mg
Day 126.77 ± 27.48536.07 ± 31.509
Day 825.33 ± 28.24329.97 ± 33.055

Adverse events

Collected over Baseline up to end of follow up visit (up to 59 days). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
OSA Cohort: Placebo0/33 (0%)1/33 (3%)0/33 (0%)
OSA Cohort: Lemborexant 10 mg0/33 (0%)0/33 (0%)2/33 (6.1%)
COPD Cohort: Placebo0/30 (0%)0/30 (0%)2/30 (6.7%)
COPD Cohort: Lemborexant 10 mg0/30 (0%)1/30 (3.3%)1/30 (3.3%)
Most frequent serious events
Most frequent serious events
EventOSA Cohort: PlaceboOSA Cohort: Lemborexant 10 mgCOPD Cohort: PlaceboCOPD Cohort: Lemborexant 10 mg
Radius fractureInjury, poisoning and procedural complications0/330/330/301/30
Ulna fractureInjury, poisoning and procedural complications0/330/330/301/30
SARS-CoV-2 test positiveInvestigations1/330/330/300/30
Most frequent other events
Most frequent other events
EventOSA Cohort: PlaceboOSA Cohort: Lemborexant 10 mgCOPD Cohort: PlaceboCOPD Cohort: Lemborexant 10 mg
HeadacheNervous system disorders0/330/332/301/30
SomnolenceNervous system disorders0/332/330/300/30

Baseline characteristics

The safety analysis set for each cohort was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.

Age, Categorical
Age, Categorical(Participants)OSA Cohort, Sequence A: Placebo + Lemborexant 10 mgOSA Cohort, Sequence B: Lemborexant 10 mg + PlaceboCOPD Cohort, Sequence C: Placebo + Lemborexant 10 mgCOPD Cohort, Sequence D: Lemborexant 10 mg + PlaceboTotal
<=18 years00000
Between 18 and 65 years11113429
>=65 years56111234
Sex: Female, Male
Sex: Female, Male(Participants)OSA Cohort, Sequence A: Placebo + Lemborexant 10 mgOSA Cohort, Sequence B: Lemborexant 10 mg + PlaceboCOPD Cohort, Sequence C: Placebo + Lemborexant 10 mgCOPD Cohort, Sequence D: Lemborexant 10 mg + PlaceboTotal
Female37111031
Male13103632
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)OSA Cohort, Sequence A: Placebo + Lemborexant 10 mgOSA Cohort, Sequence B: Lemborexant 10 mg + PlaceboCOPD Cohort, Sequence C: Placebo + Lemborexant 10 mgCOPD Cohort, Sequence D: Lemborexant 10 mg + PlaceboTotal
Hispanic or Latino522211
Not Hispanic or Latino1115121452
Unknown or Not Reported00000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)OSA Cohort, Sequence A: Placebo + Lemborexant 10 mgOSA Cohort, Sequence B: Lemborexant 10 mg + PlaceboCOPD Cohort, Sequence C: Placebo + Lemborexant 10 mgCOPD Cohort, Sequence D: Lemborexant 10 mg + PlaceboTotal
White1212131451
Black or African American341210
Japanese01001
Native Hawaiian or Other Pacific Islander10001
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Study locations

11 sites
  • Pulmonary Associates
    Glendale, Arizona 85306, United States
  • Pacific Research Network
    San Diego, California 92103, United States
  • Teradan Clinical Trials
    Brandon, Florida 33511, United States
  • St. Francis Medical Institute
    Clearwater, Florida 33765, United States
  • Research Centers of America
    Hollywood, Florida 33024, United States
  • Clinical Trials of Florida, LLC
    Miami, Florida 33186, United States
  • Clinical Site Partners Orlando, LLC
    Winter Park, Florida 32789, United States
  • NeuroTrials Research Inc.
    Atlanta, Georgia 30328, United States
  • GNP Research
    Valdosta, Georgia 31605, United States
  • CTI Clinical Trial & Consulting Services
    Cincinnati, Ohio 45212, United States
  • Intrepid Research, LLC
    Cincinnati, Ohio 45245, United States
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References and documents

Publications

  • Khullar A, Boulos MI, Mak MSB, Moline M, Cheng JY, Hall N. Effect of lemborexant on sleep parameters and architecture in adult and elderly participants with mild-to-severe obstructive sleep apnea. Sleep Med. 2025 Oct;134:106757. doi: 10.1016/j.sleep.2025.106757. Epub 2025 Aug 18. PubMed 40848323 ↗
  • Cheng JY, Lorch D, Hall N, Moline M. Respiratory safety of lemborexant in adult and elderly subjects with moderate-to-severe chronic obstructive pulmonary disease. J Sleep Res. 2025 Apr;34(2):e14334. doi: 10.1111/jsr.14334. Epub 2024 Sep 12. PubMed 39266012 ↗
  • Cheng JY, Lorch D, Lowe AD, Uchimura N, Hall N, Shah D, Moline M. A randomized, double-blind, placebo-controlled, crossover study of respiratory safety of lemborexant in moderate to severe obstructive sleep apnea. J Clin Sleep Med. 2024 Jan 1;20(1):57-65. doi: 10.5664/jcsm.10788. PubMed 37677076 ↗

Study documents

  • Study protocol · Jul 13, 2020
  • Statistical analysis plan · Aug 19, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04647383
Lead sponsor
Eisai Inc.
Responsible party
Sponsor
First posted
Nov 30, 2020
Start date
Jan 6, 2021
Primary completion
Feb 10, 2022
Completion
Feb 10, 2022
Results posted
Oct 10, 2023
Last update
Oct 10, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Lemborexant

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