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Not yet recruitingPhase 2

Lemborexant on Perioperative Sleep Quality in Patients With Brain Tumor Undergoing Surgery

Key facts

Phase
Phase 2

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Source: NCT07903051, who can take part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Beijing Tiantan Hospital
Trial code
NCT07903051
Record updated
29 October 2026
Original description
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.Read full original descriptionShow less

Effect of Lemborexant on Perioperative Sleep Quality in Patients With Brain Tumor Undergoing Surgery: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

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.

Inclusion: Patients scheduled for elective craniotomy for brain tumor resection; Age 18-65 years; ASA physical status I-III; Preoperative sleep disturbance, defined as Pittsburgh Sleep Quality Index (PSQI) score > 5; Signed informed consent.

Exclusion: Chronic use of sedative-hypnotic medications; Use of systemic moderate or strong CYP3A inhibitors and/or inducers within 1 week before surgery; Active epilepsy or poorly controlled epilepsy; Acute psychiatric illness; Severe sleep apnea, COPD, severe daytime sleepiness (Epworth Sleepiness Scale [ESS] score ≥ 16), or history of narcolepsy and/or cataplexy; Severe hepatic or renal impairment; Any condition that, in the opinion of the principal investigator, precludes participation in the study; Tumor located in the brainstem, thalamus, Wernicke's area, Broca's area, or frontal pole; Severe neurological deficit with Karnofsky Performance Status (KPS) < 60.

ClinicalTrials.gov NCT07903051