Parkinson Disease (PD), Sleep Initiation and Maintenance Disorders, Deep Brain Stimulation
Conditions
Brief 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.
Interventions
DRUGLemborexant 5 mg
Participants will receive a single oral dose of lemborexant 5 mg tablet on the night before surgery.
DRUGPlacabo
Participants will receive a oral dose of matching placebo tablet on the night before surgery.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Hoehn-Yahr stage ≥ 4 * Chronic use of sedative-hypnotic medications * 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 * Use of systemic moderate or strong CYP3A inhibitors and/or inducers within 1 week before surgery * Any condition that, in the opinion of the principal investigator, precludes participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time (TST) on the Night Before Surgery | Night before surgery | Total sleep time measured by a wrist-worn sleep monitoring device (Huawei smart band 8) during the night before deep brain stimulation surgery. TST is defined as the total duration of sleep from sleep onset to final awakening, reported in minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative subjective sleep quality | Preoperative night (assessed at 8:00-10:00 AM on the day of surgery), Postoperative days 1-3 (assessed at 8:00-10:00 AM) | Perioperative subjective sleep quality will be measured using the Richards-Campbell Sleep Questionnaire (RCSQ) score. The RCSQ is a 5-item visual analog scale assessing sleep depth, latency, awakenings, return to sleep, and sleep quality. Each item scored 0-100, total score is the mean of 5 items, range 0-100, higher scores indicate better sleep. |
| Postoperative objective sleep quality | Postoperative night 1 and night 3 (20:00 to 08:00 next day) | Sleep parameters, including total sleep time and the duration of each sleep stage, will be measured using a wrist-worn sleep monitoring device. |
| Time to Extubation | Immediately after surgery (single assessment) | Time from the end of surgery to extubation, defined as removal of the endotracheal tube. Reported in minutes. |
| Time to Awakening | Immediately after surgery (single assessment) | Time from the end of anesthesia to the first response to verbal command. Reported in minutes. |
| Perioperative Anxiety Visual Analog Scale (VAS-A) Score | Perioperative [Upon entry to the operating room (before induction of anesthesia) and 1 hour after surgery] | 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. |
| Postoperative Hospital Anxiety and Depression Scale (HADS) Score | postoperative day 1 and postoperative day 3. | 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. |
| Postoperative pain measured by Pain Numeric Rating Scale (NRS) score | 1 hour, 24 hours, 48 hours and 72 hours after surgery | 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. |
| Postoperative Quality of Recovery-15 (QoR-15) | Postoperative day 1 | 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. |
| Postoperative delirium | Within 3 days after surgery (assessed twice daily) | Number of participants who develop postoperative delirium, assessed using the 3-Minute Diagnostic Interview for CAM-defined Delirium (3D-CAM). The 3D-CAM is a structured instrument for delirium assessment. |
| Pittsburgh Sleep Quality Index (PSQI) Score at 1 Month After Surgery | 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. |
| Parkinson's Disease Questionnaire-39 (PDQ-39) Score at 1 Month After Surgery | 1 month after surgery | Parkinson's Disease Questionnaire-39 (PDQ-39) score. The PDQ-39 is a 39-item disease-specific quality of life questionnaire for Parkinson's disease. Scores are transformed to a 0-100 scale, with higher scores indicating worse quality of life. |
Contacts
CONTACTRuquan Han, PhD
Outcome results
None listed