Postoperative Sleep DisturbancePhase 4NCT07918300
Lemborexant on Perioperative Sleep Quality in Patients Undergoing Breast Cancer Surgery
A Phase 4 study testing Lemborexant 5 mg in people with Postoperative Sleep Disturbance and Breast Cancer Surgery, run by Beijing Tiantan Hospital.
Trial summary
Breast cancer is one of the most common malignancies among women worldwide, and surgery remains its primary treatment modality. Perioperative sleep disturbance, anxiety, depression, and acute postoperative pain are common complications in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Postoperative Sleep Disturbance, Breast Cancer Surgery
- What is being tested?
- Lemborexant 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 16 Oct 2026to 31 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 70 years;
- ASA I-III;
- Scheduled for elective breast cancer surgery;
- Expected length of hospital stay ≥72 hours;
- Pittsburgh Sleep Quality Index (PSQI) score >5;
- Provision of written informed consent.
Who cannot join
- Known hypersensitivity to lemborexant;
- History of narcolepsy;
- Use of sedative-hypnotics more than 4 times per week within 1 month before surgery;
- Acute phase of psychiatric illness, currently receiving antipsychotics and/or other sedative-hypnotic agents;
- Use of moderate or strong CYP3A inhibitors or inducers within 1 week before surgery;
- History of alcohol or drug abuse within 1 year before surgery;
- Severe hepatic impairment;
- Diagnosed or screened as having a high risk of moderate-to-severe sleep apnea.
About this study
Official title: The Effect of Lemborexant on Perioperative Sleep Quality in Patients Undergoing Breast Cancer Surgery: A Randomized Controlled Trial
Breast cancer is one of the most common malignancies among women worldwide, and surgery remains its primary treatment modality. Perioperative sleep disturbance, anxiety, depression, and acute postoperative pain are common complications in breast cancer patients. Among these, sleep disturbance is the most common and can exacerbate negative emotions and postoperative pain, delay postoperative recovery, and severely impair patients' psychological well-being and rehabilitation quality. Traditional benzodiazepine sedative-hypnotics are of limited use in the perioperative setting because of drawbacks such as drug dependence and withdrawal reactions. As a novel dual orexin receptor antagonist, lemborexant regulates sleep-wake balance, is non-addictive, and exhibits a superior safety profile. However, studies on its perioperative application in breast cancer patients remain scarce, and robust clinical evidence supporting its use is lacking. This prospective, randomized, double-blind, placebo-controlled clinical trial was designed primarily to investigate the efficacy of lemborexant in improving perioperative sleep quality in breast cancer patients, and secondarily to observe its effects on anxiety, depression, and acute postoperative pain, as well as to evaluate its safety profile. The findings of this study are expected to provide a safe and effective novel intervention strategy for the standardized perioperative management of sleep, mood, and pain in breast cancer patients, and to generate reliable evidence for optimizing enhanced recovery after surgery (ERAS) programs.
- Being tested
- Lemborexant 5 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lemborexant 5 mgDrug
The intervention group will take Lemborexant tablets three times during the perioperative period
PlaceboDrug
The control group will take placebo tablets with the same appearance, smell and properties as the intervention group three times during the perioperative period
| Study group | Role | What they receive |
|---|---|---|
| lemborexant | Experimental | the intervention group Receives: Drug: Lemborexant 5 mg |
| placebo | Placebo comparator | the control group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Richards-Campbell Sleep Questionnaire (RCSQ) total score
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.
Measured: The first postoperative night (assessed at 8:00 on the morning of postoperative day 1)
Secondary outcomes (7)
Area under the curve (AUC) of the RCSQ total score
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.
Measured: 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)
Athens Insomnia Scale (AIS) total score
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.
Measured: Postoperative day 5 or discharge
Objective sleep quality
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.
Measured: Night before surgery, postoperative night 1 and postoperative night 2 (20:00 to 08:00 next day)
Postoperative pain Numeric Rating Scale (NRS) score
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.
Measured: 24 and 48 hours postoperatively
Change from baseline in Hospital Anxiety and Depression Scale (HADS) score
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.
Measured: Baseline (before surgery) and postoperative day 2
Quality of Recovery-15 (QoR-15) total score
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.
Measured: Postoperative day 2
Overall medication satisfaction score
Overall medication satisfaction will be assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Higher scores indicate greater satisfaction.
Measured: Postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start16 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918300
- Sponsor's protocol ID
- LAM-20260912
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lemborexant on Perioperative Sleep Quality in Patients Undergoing Breast Cancer Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07918300
- Acronym / sponsor ID
- LAM-20260912
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 16 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is one of the most common malignancies among women worldwide, and surgery remains its primary treatment modality. Perioperative sleep disturbance, anxiety, depression, and acute postoperative pain are common complications in breast cancer patients. Among these, sleep disturbance is the most common and can exacerbate negative emotions and postoperative pain, delay postoperative recovery, and severely impair patients' psychological well-being and rehabilitation quality. Traditional benzodiazepine sedative-hypnotics are of limited use in the perioperative setting because of drawbacks such as drug dependence and withdrawal reactions. As a novel dual orexin receptor antagonist, lemborexant regulates sleep-wake balance, is non-addictive, and exhibits a superior safety profile. However, studies on its perioperative application in breast cancer patients remain scarce, and robust clinical evidence supporting its use is lacking. This prospective, randomized, double-blind, placebo-controlled clinical trial was designed primarily to investigate the efficacy of lemborexant in improving perioperative sleep quality in breast cancer patients, and secondarily to observe its effects on anxiety, depression, and acute postoperative pain, as well as to evaluate its safety profile. The findings of this study are expected to provide a safe and effective novel intervention strategy for the standardized perioperative management of sleep, mood, and pain in breast cancer patients, and to generate reliable evidence for optimizing enhanced recovery after surgery (ERAS) programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lemborexant | Experimental | Drug: Lemborexant 5 mgthe intervention group |
| placebo | Placebo comparator | Drug: Placebothe control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 70 years;
- ASA I-III;
- Scheduled for elective breast cancer surgery;
- Expected length of hospital stay ≥72 hours;
- Pittsburgh Sleep Quality Index (PSQI) score >5;
Key exclusion criteria (8 listed)
- Known hypersensitivity to lemborexant;
- History of narcolepsy;
- Use of sedative-hypnotics more than 4 times per week within 1 month before surgery;
- Acute phase of psychiatric illness, currently receiving antipsychotics and/or other sedative-hypnotic agents;
- Use of moderate or strong CYP3A inhibitors or inducers within 1 week before surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lemborexant 5 mgThe intervention group will take Lemborexant tablets three times during the perioperative period | Drug | lemborexant |
| PlaceboThe control group will take placebo tablets with the same appearance, smell and properties as the intervention group three times during the perioperative period | Drug | placebo |
Primary outcome
Richards-Campbell Sleep Questionnaire (RCSQ) total score
Time frame: 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.
7 secondary outcomes
Area under the curve (AUC) of the RCSQ total score
Time frame: 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)
Athens Insomnia Scale (AIS) total score
Time frame: Postoperative day 5 or discharge
Objective sleep quality
Time frame: Night before surgery, postoperative night 1 and postoperative night 2 (20:00 to 08:00 next day)
Postoperative pain Numeric Rating Scale (NRS) score
Time frame: 24 and 48 hours postoperatively
Change from baseline in Hospital Anxiety and Depression Scale (HADS) score
Time frame: Baseline (before surgery) and postoperative day 2
Quality of Recovery-15 (QoR-15) total score
Time frame: Postoperative day 2
Overall medication satisfaction score
Time frame: Postoperative day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lemborexant 5 mg in people with Postoperative Sleep Disturbance and Breast Cancer Surgery, run by Beijing Tiantan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Richards-Campbell Sleep Questionnaire (RCSQ) total score (time frame: The first postoperative night (assessed at 8:00 on the morning of postoperative day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.