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CompletedNCT04445688Updated Sep 14, 2023Results posted

Crossover Trial of AD036 in Obstructive Sleep Apnea

A Phase 2 interventional study of AD036 and Atomoxetine in Obstructive Sleep Apnea, sponsored by Apnimed. Completed at 5 sites in United States. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-14.

Sponsored by Apnimed · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study summary

This is a randomized, 3-Period, Placebo-Controlled, Crossover, phase 2 clinical study to examine the efficacy and safety of AD036 versus placebo or atomoxetine in patients with obstructive sleep apnea.

Read the detailed description

The study is designed to examine the efficacy and safety of AD036 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight Home Sleep Apnea Testing (HSAT) with dosing of one of the following 3 treatments: AD036, Atomoxetine, or Placebo. Participants will return 1 week after their final crossover HSAT for an end of study (EOS) Visit.

02

Conditions studied

  • Obstructive Sleep Apnea
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 62 is above the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Apnimed is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.

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

04

Who can participate

Ages eligible
25 Years to 65 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

  • Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.
  • AHI 10 to \<20, or AHI ≥20 if meets PSG criteria

Exclusion criteria

Exclusion Criteria:

  • History of narcolepsy.
  • Clinically significant craniofacial malformation.
  • Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
  • CPAP should not be used for at least 2 weeks prior to first study PSG
  • History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    AD036

    AD036 oral capsule administered before sleep

    Drug: AD036

  • Active comparator
    Atomoxetine

    Atomoxetine oral capsule administered before sleep

    Drug: Atomoxetine

  • Placebo comparator
    Placebo

    Placebo oral capsule administered before sleep

    Drug: Placebo

Interventions

  • DrugAD036

    Oral administration before bed

  • DrugAtomoxetine

    Oral administration before bed

  • DrugPlacebo

    Oral administration before bed

06

What researchers measure

Primary outcomes

  1. Apnea-Hypopnea Index

    Apnea-Hypopnea Index(Disease severity is often defined based on the number of apneas and hypopneas per hour during sleep), AD036 vs. placebo

    Time frame: 1 day

Secondary outcomes

  1. Hypoxic Burden

    Hypoxic burden (a way to measure oxygen desaturation) determined by measuring the respiratory event-associated area under the desaturation curve from pre-event baseline, AD036 vs. placebo. Hypoxic Burden was measured during polysomnography (type of sleep study), while the patient was asleep

    Time frame: 1 day

  2. ODI

    Oxygen Desaturation Index, measured by pulse-oximetry, AD036 vs. placebo

    Time frame: 1 day

07

Results

Posted Aug 21, 2023

Participant flow

5 clinical sites screened 101 participants 62 were randomized. This was an unblinded three period placebo controlled study. Participants who withdrew were not replaced.

First Intervention
Participant flow — First Intervention
MilestoneAll Participants
Started62
Treatment a21
Treatment b21
Treatment c20
Completed62
Not completed0
Washout (One Week)
Participant flow — Washout (One Week)
MilestoneAll Participants
Started62
Completed59
Not completed3
Withdrew: Adverse event2
Withdrew: Withdrawal by subject1
Second Intervention
Participant flow — Second Intervention
MilestoneAll Participants
Started59
Treatment a18
Treatment b21
Treatment c20
Completed59
Not completed0
Washout (One Week)
Participant flow — Washout (One Week)
MilestoneAll Participants
Started59
Completed59
Not completed0
Third Intervention
Participant flow — Third Intervention
MilestoneAll Participants
Started59
Treatment a20
Treatment b20
Treatment c19
Completed59
Not completed0

Outcome measures

PrimaryApnea-Hypopnea Index

Apnea-Hypopnea Index(Disease severity is often defined based on the number of apneas and hypopneas per hour during sleep), AD036 vs. placebo

Time frame:
1 day
Reported as:
Least squares mean · events/hour
Apnea-Hypopnea Index
events/hourAD036AtomoxetinePlacebo
Apnea-Hypopnea Index11.5 (7.2 to 15.8)11.5 (7.2 to 15.8)18.8 (14.5 to 23.1)
Statistical analysis
  • AD036 vs Placebo · ANOVA · p = <0.0001 · Difference in least squares mean: -7.3 · 95% CI -10.2 to -4.4
SecondaryHypoxic Burden

Hypoxic burden (a way to measure oxygen desaturation) determined by measuring the respiratory event-associated area under the desaturation curve from pre-event baseline, AD036 vs. placebo. Hypoxic Burden was measured during polysomnography (type of sleep study), while the patient was asleep

Time frame:
1 day
Reported as:
Least squares mean · %min/hour
Hypoxic Burden
%min/hourAD036AtomoxetinePlacebo
Hypoxic Burden24.3 (13.5 to 35.1)26.8 (16.1 to 37.6)46.1 (35.4 to 56.8)
Statistical analysis
  • AD036 vs Placebo · ANOVA · p = <0.0001 · Difference in least squares mean: -21.8 · 95% CI -29.5 to -14.1
SecondaryODI

Oxygen Desaturation Index, measured by pulse-oximetry, AD036 vs. placebo

Time frame:
1 day
Reported as:
Least squares mean · events/hour
ODI
events/hourAD036AtomoxetinePlacebo
ODI12.8 (8.4 to 17.1)13.3 (9.0 to 17.7)20.1 (15.8 to 24.4)
Statistical analysis
  • AD036 vs Placebo · ANOVA · p = <0.0001 · Difference in least squares mean: -7.3 · 95% CI -10.5 to -4.2

Adverse events

Collected over 10 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AD0360/59 (0%)0/59 (0%)8/59 (13.6%)
Atomoxetine0/62 (0%)0/62 (0%)11/62 (17.7%)
Placebo0/59 (0%)0/59 (0%)5/59 (8.5%)
Most frequent other events
Most frequent other events
EventAD036AtomoxetinePlacebo
InsomniaPsychiatric disorders5/597/624/59
NauseaGastrointestinal disorders3/594/621/59

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)All Participants
<=18 years0
Between 18 and 65 years59
>=65 years3
Age, Continuous
Age, Continuous(years)All Participants
Median53 (28 to 66)
Sex: Female, Male
Sex: Female, Male(Participants)All Participants
Female31
Male31
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)All Participants
Hispanic or Latino4
Not Hispanic or Latino58
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Participants
American Indian or Alaska Native1
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American17
White41
More than one race1
Unknown or Not Reported0
BMI (kg/m^2)
BMI (kg/m^2)(kg/m^2)All Participants
Median32.30 (22.6 to 39.6)
08

Study locations

5 sites
  • Preferred Research Partners, Inc.
    Little Rock, Arkansas 72211, United States
  • SDS Clinical Trials, Inc.
    Santa Ana, California 92705, United States
  • The Center for Sleep and Wake Disorders
    Chevy Chase, Maryland 20815, United States
  • Sleep Medicine & Research Center, St. Luke's Hospital
    Chesterfield, Missouri 63017, United States
  • CTI Clinical Research Center
    Cincinnati, Ohio 45212, United States
09

References and documents

Publications

  • Schweitzer PK, Maynard JP, Wylie PE, Emsellem HA, Sands SA. Efficacy of atomoxetine plus oxybutynin in the treatment of obstructive sleep apnea with moderate pharyngeal collapsibility. Sleep Breath. 2023 May;27(2):495-503. doi: 10.1007/s11325-022-02634-x. Epub 2022 May 13. PubMed 35551600 ↗

Study documents

  • Study protocol · Sep 15, 2020
  • Statistical analysis plan · Sep 18, 2020

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04445688
Lead sponsor
Apnimed
Responsible party
Sponsor
First posted
Jun 24, 2020
Start date
Jul 15, 2020
Primary completion
Dec 1, 2020
Completion
Dec 1, 2020
Results posted
Aug 21, 2023
Last update
Sep 14, 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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