Trial · NCT07903038
Lemborexant on Perioperative Sleep Quality in Patients With Parkinson's Disease Undergoing Deep Brain Stimulation
NCT07903038, Phase 2, Not yet recruiting, Beijing Tiantan Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lemborexant on Perioperative Sleep Quality in Patients With Parkinson's Disease Undergoing Deep Brain Stimulation. Trials, record NCT07903038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07903038
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lemborexant on Perioperative Sleep Quality in Patients With Parkinson's Disease Undergoing Deep Brain Stimulation
- NCT number
- NCT07903038
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 128 participants, estimated
- Lead sponsor
- Beijing Tiantan Hospital
- Conditions
- Parkinson Disease (PD), Sleep Initiation and Maintenance Disorders, Deep Brain Stimulation
- Interventions
- Lemborexant 5 mg, Placabo
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Time to Awakening | Immediately after surgery (single assessment) | Time from the end of anesthesia to the first response to verbal command. Reported in minutes. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07903038
GET https://conductscience.org/api/trials/v1/NCT07903038/registered