Trial intelligence / Profile preview

Lemborexant for Perioperative Sleep Quality in Parkinson's Disease Undergoing DBS

NCT07903038Phase 2

Key facts

Status: Not yet recruiting
Start: Nov 2026
Primary completion: Dec 2027
Sponsor: Beijing Tiantan Hospital

Drugs: lemborexant
Conditions: insomnia disorder

Overview

Phase 2, randomised, double-blind trial in insomnia disorder comparing Lemborexant 5 mg with Placebo (2 arms). Primary endpoint: Total Sleep Time. Planned start Nov 2026; status: not yet recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Lemborexant 5 mg
Single oral dose of lemborexant 5 mg tablet on the night before surgery
Placebo
Single oral dose of matching placebo tablet on the night before surgery

Who it enrols

Patients aged 50-80 with Parkinson's disease scheduled for elective DBS surgery under general anesthesia, with preoperative sleep disturbance (PSQI > 5).

Endpoints

Primary

Total Sleep TimeNight before surgery

Secondary

Perioperative subjective sleep qualityPostoperative days 1-3
Postoperative objective sleep qualityPostoperative night 3
Time to ExtubationImmediately after surgery
Time to AwakeningImmediately after surgery
Perioperative Anxiety Visual Analog Scale1 hour after surgery
Postoperative Hospital Anxiety and Depression ScalePostoperative day 3
Pain Numeric Rating Scale72 hours after surgery
Postoperative Quality of Recovery-15Postoperative day 1

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