A Phase 2 interventional study of Lemborexant 5 mg and placebo in Brain Neoplasms and Sleep Initiation and Maintenance Disorders, sponsored by Beijing Tiantan Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Beijing Tiantan Hospital · Phase 2, Interventional, and Treatment
This study tests whether lemborexant can improve perioperative sleep quality in people with brain tumor undergoing surgery. Adults with brain tumor scheduled for surgery may join. Participants will be randomly assigned to take lemborexant or a placebo the night before surgery. Researchers will measure sleep quality, anesthesia recovery, pain, postoperative recovery, and other outcomes.
2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.
This study's planned enrollment of 112 is above the median of 40 across 1,831 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single oral dose of lemborexant 5 mg tablet on the night before brain tumor surgery.
Drug: Lemborexant 5 mg
Participants will receive a single oral dose of matching placebo tablet on the night before brain tumor surgery.
Drug: placebo
Participants will receive a single oral dose of lemborexant 5 mg tablet on the night before brain tumor surgery.
Participants will receive a single oral dose of matching placebo tablet on the night before brain tumor surgery.
Total Sleep Time (TST) on the Night Before Surgery
Total sleep time measured by a wrist-worn sleep monitoring device (Huawei smart band) during the night before brain tumor surgery. TST is defined as the total duration of sleep from sleep onset to final awakening, reported in minutes.
Time frame: Night before surgery
Subjective sleep quality
Richards-Campbell Sleep Questionnaire (RCSQ) score. The RCSQ is a 5-item visual analog scale assessing sleep depth, sleep onset latency, awakenings, time spent awake, and overall sleep quality. Each item scored 0-100, total score is the mean of 5 items, range 0-100, higher scores indicate better sleep.
Time frame: Preoperative day 1, Postoperative days 1-3 (assessed at 8:00-10:00 AM)
Objective sleep quality
Total sleep time measured by a wrist-worn sleep monitoring device (Huawei smart band) during the night of postoperative day 0. Reported in minutes.
Time frame: Postoperative night 0 (20:00 to 08:00 next day) and Postoperative night 2 (20:00 to 08:00 next day)
Time to Extubation
Time from the end of surgery to extubation, defined as removal of the endotracheal tube. Reported in minutes.
Time frame: Immediately after surgery
Time to Awakening
Time from the end of anesthesia to the first response to verbal command. Reported in minutes.
Time frame: Immediately after surgery
Perioperative Anxiety Visual Analog Scale (VAS-A) Score
Anxiety Visual Analog Scale (VAS-A) score. The VAS-A is a 100-mm horizontal line anchored at 0 (no anxiety) and 100 (worst possible anxiety). The participant marks a point on the line corresponding to their anxiety level. Higher scores indicate greater anxiety. VAS-A score assessed upon entry to the operating room (before induction of anesthesia) and 1 hour after surgery.
Time frame: Perioperative [Upon entry to the operating room (before induction of anesthesia), and 1 hour after surgery]
Postoperative Hospital Anxiety and Depression Scale (HADS) Score
The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-rated questionnaire comprising two 7-item subscales: anxiety (HADS-A) and depression (HADS-D). Each item is scored from 0 to 3. Each subscale score ranges from 0 to 21, with higher scores indicating greater symptom severity.
Time frame: Postoperative day 1 and 3 (assessed at 8:00-10:00 AM)
Postoperative pain measured by Pain Numeric Rating Scale (NRS) score
Pain Numeric Rating Scale (NRS) score. The NRS is an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.
Time frame: 1 hour after surgery, 24 hours, 48 hours and 72 hours after surgery.
Postoperative Quality of Recovery-15 (QoR-15)
Quality of Recovery-15 (QoR-15) score. The QoR-15 is a 15-item questionnaire assessing postoperative recovery across physical comfort, emotional state, and physical independence. Each item scored 0-10, total range 0-150, higher scores indicate better recovery quality.
Time frame: Postoperative day 1
Incidence of Postoperative Delirium
Postoperative delirium will be assessed using the 3-Dimensional Confusion Assessment Method (3D-CAM). The 3D-CAM is a structured diagnostic interview that determines the presence or absence of CAM-defined delirium. Delirium incidence is the number of participants with at least one positive 3D-CAM assessment.
Time frame: Within 3 days after surgery (assessed twice daily)
Pittsburgh Sleep Quality Index (PSQI) Score at 1 Month After Surgery
Pittsburgh Sleep Quality Index (PSQI) score. The PSQI is a 19-item self-rated questionnaire assessing sleep quality over the past month. Seven component scores are summed to yield a global score ranging from 0 to 21. Higher scores indicate worse sleep quality.
Time frame: 1 month after surgery
Karnofsky Performance Status (KPS) Score at 1 Month After Surgery
Karnofsky Performance Status (KPS) score. The KPS is a clinician-rated scale ranging from 0 to 100, with scores assigned in 10-point increments. Higher scores indicate better functional status and greater ability to carry out daily activities independently. Assessed by a clinician at 1 month after surgery.
Time frame: 1 month after surgery
Total Sleep Time (TST) as Measured by Polysomnography (PSG)
Total sleep time, defined as the total duration of sleep from sleep onset to final awakening, measured by 8-channel polysomnography. Reported in minutes.
Time frame: Preoperative Day 1 (the night before surgery)
Sleep Efficiency (SE) as Measured by Polysomnography (PSG)
Sleep efficiency, defined as total sleep time divided by total time in bed, expressed as a percentage. Measured by 8-channel polysomnography.
Time frame: Preoperative Day 1 (the night before surgery)
Sleep Onset Latency (SOL) as Measured by Polysomnography (PSG)
Sleep onset latency, defined as the time from lights off to the first epoch of any sleep stage, measured by 8-channel polysomnography. Reported in minutes.
Time frame: Preoperative Day 1 (the night before surgery)
Percentage of Rapid Eye Movement (REM) Sleep as Measured by Polysomnography (PSG)
Percentage of total sleep time spent in REM sleep, measured by 8-channel polysomnography. Reported as a percentage.
Time frame: Preoperative Day 1 (the night before surgery)
Percentage of Non-REM Stage N3 Sleep as Measured by Polysomnography (PSG)
Percentage of total sleep time spent in N3 (slow-wave) sleep, measured by 8-channel polysomnography. Reported as a percentage.
Time frame: Preoperative Day 1 (the night before surgery)
Wake After Sleep Onset (WASO) as Measured by Polysomnography (PSG)
Wake after sleep onset, defined as the total time spent awake after initial sleep onset, measured by 8-channel polysomnography. Reported in minutes.
Time frame: Preoperative Day 1 (the night before surgery)
Plasma Orexin-A Level
Fasting plasma orexin-A concentration measured by enzyme-linked immunosorbent assay (ELISA). Reported in pg/mL.
Time frame: Preoperative day 1, day of surgery (before anesthesia induction), postoperative day 1
Number of Participants with Treatment-Emergent Adverse Events
Number of participants experiencing any adverse event during the perioperative period, including but not limited to falls, nocturnal hypoxemia, abnormal dreams, somnolence, constipation, arthralgia, and headache.
Time frame: Perioperative period (from study drug administration on the night before surgery through hospital discharge, approximately 5 days)
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lemborexant