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NOT YET RECRUITING
NCT07903038
PHASE2

Lemborexant on Perioperative Sleep Quality in Patients With Parkinson's Disease Undergoing Deep Brain Stimulation

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

This study tests whether lemborexant, an approved sleep medicine, can improve sleep and recovery in people with Parkinson's disease undergoing deep brain stimulation (DBS) surgery. Sleep problems are common around surgery and may worsen pain and slow recovery. Participants will be randomly assigned to take lemborexant or a placebo the night before surgery. Researchers will compare anesthesia use, wake-up time, sleep quality (objective and subjective), pain, recovery, and blood markers. The study will show whether lemborexant is safe and helpful for this group.

Official title: Effect of Lemborexant on Perioperative Sleep Quality in Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: A Randomized, Double-blinded, Placebo-controlled Clinical Trial

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2026-11-01

Completion Date

2027-12-31

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

DRUG

Lemborexant 5 mg

Participants will receive a single oral dose of lemborexant 5 mg tablet on the night before surgery.

DRUG

Placabo

Participants will receive a oral dose of matching placebo tablet on the night before surgery.