Lemborexant on Perioperative Sleep Quality in Patients Undergoing Breast Cancer Surgery
NCT07918300, Phase 4, Not yet recruiting, Beijing Tiantan Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Lemborexant on Perioperative Sleep Quality in Patients Undergoing Breast Cancer Surgery | ClinicalTrials.gov |
| NCT number | NCT07918300 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 106 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beijing Tiantan Hospital | ClinicalTrials.gov |
| Conditions | Postoperative Sleep Disturbance, Breast Cancer Surgery | ClinicalTrials.gov |
| Interventions | Lemborexant 5 mg, Placebo | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Richards-Campbell Sleep Questionnaire (RCSQ) total score | The first postoperative night (assessed at 8:00 on the morning of postoperative day 1) | RCSQ comprises five core items evaluating distinct sleep domains: sleep depth, sleep latency, frequency of awakenings, ability to return to sleep, and overall sleep quality. Each item is scored on a 0-100 scale. The total score is calculated as the mean of the five core item scores, yielding a range from 0 to 100. A higher total score indicates better perceived sleep quality. Specifically, a score of 0 represents the worst possible sleep, while a score of 100 represents the best possible sleep. | ClinicalTrials.gov |
| Secondary | Area under the curve (AUC) of the RCSQ total score | Night before surgery, postoperative night 1 and postoperative night 2 (assessed at 08:00 on the morning of the day of surgery, postoperative day 1, and postoperative day 2) | Area under the curve (AUC) of the RCSQ total score, calculated using the linear trapezoidal rule from RCSQ total scores obtained for the night before surgery, postoperative night 1 and postoperative night 2. | ClinicalTrials.gov |
| Secondary | Athens Insomnia Scale (AIS) total score | Postoperative day 5 or discharge | Insomnia severity will be assessed using the Athens Insomnia Scale (AIS-8), an 8-item self-report questionnaire based on ICD-10 insomnia criteria. Each item is scored on a 0-3 scale, yielding a total score of 0-24. Higher scores indicate more severe insomnia. The scale assesses sleep difficulty over the past week. | ClinicalTrials.gov |
| Secondary | Objective sleep quality | Night before surgery, postoperative night 1 and postoperative night 2 (20:00 to 08:00 next day) | Objective sleep parameters recorded by sleep wristband, including total sleep time (TST, min) and wake after sleep onset (WASO, min), monitored during the night before surgery, postoperative night 1 and postoperative night 2. | ClinicalTrials.gov |
| Secondary | Postoperative pain Numeric Rating Scale (NRS) score | 24 and 48 hours postoperatively | Postoperative resting pain and pain with movement were measured using the Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) at 24 and 48 hours postoperatively. | ClinicalTrials.gov |
| Secondary | Change from baseline in Hospital Anxiety and Depression Scale (HADS) score | Baseline (before surgery) and postoperative day 2 | Anxiety and depressive symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS), including anxiety subscale (HADS-A) and depression subscale (HADS-D). Each subscale score ranges from 0 to 21, with higher scores indicating more severe symptoms. | ClinicalTrials.gov |
| Secondary | Quality of Recovery-15 (QoR-15) total score | Postoperative day 2 | QoR-15 is a 15-item patient-reported outcome measure of postoperative recovery, covering pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10, yielding a total score of 0-150, with higher scores indicating better recovery. | ClinicalTrials.gov |
| Secondary | Overall medication satisfaction score | Postoperative day 2 | Overall medication satisfaction will be assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Higher scores indicate greater satisfaction. | ClinicalTrials.gov |
| Other | Change from baseline in Pittsburgh Sleep Quality Index (PSQI) total score | Baseline and postoperative day 30 | The Pittsburgh Sleep Quality Index (PSQI) total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. The outcome is the change in the PSQI total score from baseline to postoperative day 30. | ClinicalTrials.gov |
| Other | Change from baseline in Hospital Anxiety and Depression Scale (HADS) score | Baseline and postoperative day 30 | Anxiety and depressive symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS), including anxiety subscale (HADS-A) and depression subscale (HADS-D). Each subscale score ranges from 0 to 21, with higher scores indicating more severe symptoms. | ClinicalTrials.gov |
| Other | Pain Numeric Rating Scale (NRS) score | Postoperative day 30 | Resting pain and pain with movement were measured using the Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) at 24 and 48 hours postoperatively. | ClinicalTrials.gov |
| Other | DN4-interview score | Postoperative day 30 | The DN4-interview consists of 7 interview items, with a total score ranging from 0 to 7. Higher scores indicate more prominent neuropathic pain features. | ClinicalTrials.gov |
| Other | Safety and Adverse Events | From the first dose of study medication until hospital discharge or up to 7 days after the first dose, whichever occurs first. | Safety will be assessed by the frequency and nature of adverse events (AEs) and serious adverse events (SAEs) potentially related to the study medication. Adverse events, including but not limited to somnolence, abnormal dreams, headache, fatigue, sleep paralysis, dizziness, falls, nocturnal hypoxemia, oversedation and respiratory compromise, will be identified via daily clinical assessment and medical record review. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)