Postoperative Sleep DisturbancePhase 2NCT07811401
Lemborexant on Perioperative Sleep Quality in Patients Undergoing Thoracoscopic Surgery
A Phase 2 study testing Lemborexant 5 mg in people with Postoperative Sleep Disturbance and Thoracoscopic Surgery, run by Beijing Tiantan Hospital.
Trial summary
Video-assisted thoracoscopic surgery (VATS) is the mainstream minimally invasive procedure in thoracic surgery; However, the high-stress state during the perioperative period and severe postoperative pain often lead to significant disruption of patients' sleep patterns, thereby exacerbating postoperative pain… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Sleep Disturbance, Thoracoscopic 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
- 130 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2026to 1 Jun 2028
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 70 years;
- ASA I-III;
- Patients scheduled to undergo elective video-assisted thoracoscopic surgery (VATS) under general anaesthesia, including wedge resection, segmentectomy and lobectomy;
- Pre-operative Pittsburgh Sleep Quality Index (PSQI) score > 5 points;
- Expected post-operative hospital stay of ≥3 days;
- Signing of a written informed consent form.
Who cannot join
- Patients whose surgery is expected to finish after 19:00, or who will remain intubated post-operatively or require admission to the ICU;
- Patients with a pre-operative diagnosis of moderate to severe obstructive sleep apnoea (OSA);
- Patients who take sedatives, sleeping tablets or antidepressants on a long-term basis;
- Patients with moderate to severe hepatic or renal impairment;
- Patients with cognitive impairment preventing them from cooperating with scale-based assessments;
- Patients with pre-existing chronic neuropathic pain;
- Patients unsuitable for or refusing to participate in this study for other. reasons.
About this study
Official title: The Effect of Lemborexant on Perioperative Sleep Quality in Patients Undergoing Thoracoscopic Surgery: A Randomized Controlled Trial
Video-assisted thoracoscopic surgery (VATS) is the mainstream minimally invasive procedure in thoracic surgery; However, the high-stress state during the perioperative period and severe postoperative pain often lead to significant disruption of patients' sleep patterns, thereby exacerbating postoperative pain sensitisation and delaying early recovery. Traditional sleep-inducing drugs, primarily benzodiazepines, have significant limitations in the perioperative period of thoracic surgery, including respiratory depression, dizziness and residual central effects, which hinder early ambulation. As a new-generation dual orexin receptor antagonist, Lemborexant exerts its sleep-promoting and anti-stress effects by precisely blocking excessive arousal pathways. Furthermore, it causes no respiratory depression, no hangover-like effects the following day, and does not impair muscle strength or mucus clearance, offering the potential to meet the dual requirements of sleep quality and high safety in Enhanced Recovery After Surgery (ERAS) protocols for thoracic surgery. However, there remains a lack of prospective clinical evidence regarding its application in the high-stress, high-pain perioperative acute cohort of thoracoscopic surgery. This study aims to conduct a prospective, randomised, double-blind, placebo-controlled clinical trial to improve perioperative sleep quality in VATS patients. The primary outcome measure of the study was the difference in the incidence of perioperative sleep disorders (PSD) between the two groups, as assessed by the total Richards-Campbell Sleep Questionnaire (RCSQ) score on the night of surgery. The study aims to investigate the causal relationship between short-term perioperative Lemborexant intervention and improvements in patient sleep and postoperative recovery quality. The anticipated results will provide clinical evidence of the safety and efficacy of Lemborexant for use in high-stress populations during the perioperative period.
- 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.
The incidence of postoperative sleep disturbance (PSD)
Differences in the incidence of perioperative sleep disorders (PSD) between the two groups, as assessed by the total score on the Richards-Campbell Sleep Questionnaire (RCSQ). The scale 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 rated on a 100-mm visual analogue scale (VAS). 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 night after the operation
Secondary outcomes (3)
Objective sleep quality
Total sleep time (TST) and wake time after sleep onset (WASO) as monitored by the Huawei sleep tracker.
Measured: From the night before surgery to the second night after surgery (three consecutive nights).
Postoperative pain scores
Resting pain (NRS-R) and movement-induced pain (NRS-C) at 24 and 48 hours postoperation. Assessment was carried out using a numerical rating scale for pain intensity.
Measured: At 24 and 48 hours postoperation
Postoperative anxiety and depression
The Hospital Anxiety and Depression Scale (HADS) was used to assess changes in perioperative anxiety and depression subscale scores compared with baseline values.
Measured: The day before the operation and on the third day after the operation, or upon discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start8 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jun 2028 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 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
- NCT07811401
- Sponsor's protocol ID
- LV-20260903
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2026
- Last updated
- 20 Oct 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 20 Oct 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 Thoracoscopic Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07811401
- Acronym / sponsor ID
- LV-20260903
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 10 Sep 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.
Video-assisted thoracoscopic surgery (VATS) is the mainstream minimally invasive procedure in thoracic surgery; However, the high-stress state during the perioperative period and severe postoperative pain often lead to significant disruption of patients' sleep patterns, thereby exacerbating postoperative pain sensitisation and delaying early recovery. Traditional sleep-inducing drugs, primarily benzodiazepines, have significant limitations in the perioperative period of thoracic surgery, including respiratory depression, dizziness and residual central effects, which hinder early ambulation. As a new-generation dual orexin receptor antagonist, Lemborexant exerts its sleep-promoting and anti-stress effects by precisely blocking excessive arousal pathways. Furthermore, it causes no respiratory depression, no hangover-like effects the following day, and does not impair muscle strength or mucus clearance, offering the potential to meet the dual requirements of sleep quality and high safety in Enhanced Recovery After Surgery (ERAS) protocols for thoracic surgery. However, there remains a lack of prospective clinical evidence regarding its application in the high-stress, high-pain perioperative acute cohort of thoracoscopic surgery. This study aims to conduct a prospective, randomised, double-blind, placebo-controlled clinical trial to improve perioperative sleep quality in VATS patients. The primary outcome measure of the study was the difference in the incidence of perioperative sleep disorders (PSD) between the two groups, as assessed by the total Richards-Campbell Sleep Questionnaire (RCSQ) score on the night of surgery. The study aims to investigate the causal relationship between short-term perioperative Lemborexant intervention and improvements in patient sleep and postoperative recovery quality. The anticipated results will provide clinical evidence of the safety and efficacy of Lemborexant for use in high-stress populations during the perioperative period.
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
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 70 years;
- ASA I-III;
- Patients scheduled to undergo elective video-assisted thoracoscopic surgery (VATS) under general anaesthesia, including wedge resection, segmentectomy and lobectomy;
- Pre-operative Pittsburgh Sleep Quality Index (PSQI) score > 5 points;
- Expected post-operative hospital stay of ≥3 days;
Key exclusion criteria (7 listed)
- Patients whose surgery is expected to finish after 19:00, or who will remain intubated post-operatively or require admission to the ICU;
- Patients with a pre-operative diagnosis of moderate to severe obstructive sleep apnoea (OSA);
- Patients who take sedatives, sleeping tablets or antidepressants on a long-term basis;
- Patients with moderate to severe hepatic or renal impairment;
- Patients with cognitive impairment preventing them from cooperating with scale-based assessments;
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
The incidence of postoperative sleep disturbance (PSD)
Time frame: The first night after the operation
Differences in the incidence of perioperative sleep disorders (PSD) between the two groups, as assessed by the total score on the Richards-Campbell Sleep Questionnaire (RCSQ). The scale 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 rated on a 100-mm visual analogue scale (VAS). 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.
3 secondary outcomes
Objective sleep quality
Time frame: From the night before surgery to the second night after surgery (three consecutive nights).
Postoperative pain scores
Time frame: At 24 and 48 hours postoperation
Postoperative anxiety and depression
Time frame: The day before the operation and on the third day after the operation, or upon discharge
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 20 Oct 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 2 study testing Lemborexant 5 mg in people with Postoperative Sleep Disturbance and Thoracoscopic 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 7 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 20 Oct 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The incidence of postoperative sleep disturbance (PSD) (time frame: The first night after the operation). 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 20 Oct 2026.