NCT07903038Not yet recruitingPhase 2
Lemborexant on Perioperative Sleep Quality in Patients With Parkinson's Disease Undergoing Deep Brain Stimulation
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
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- First submitted
- 13 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Beijing Tiantan Hospital
- Diseases
- Parkinson disease
- NCT number
- NCT07903038
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 128
- From 1 Nov 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic use of sedative-hypnotic medications
- Use of systemic moderate or strong CYP3A inhibitors and/or inducers within 1 week before surgery
Other illness
- Acute psychiatric illness
- Severe sleep apnea, COPD, severe daytime sleepiness (Epworth Sleepiness Scale \[ESS\] ≥ 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
Other
- Hoehn-Yahr stage ≥ 4
Who the study is looking for
- Patients with Parkinson's disease scheduled for elective DBS surgery under general anesthesia
- Age 50-80 years
- ASA physical status I-III
- Preoperative sleep disturbance, defined as Pittsburgh Sleep Quality Index (PSQI) score \> 5
- Signed informed consent
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.