The Optimal One-Month Dosing of Lemborexant for Moderate Obstructive Sleep Apnea (OSA) Patients With Low Arousal Threshold (LMOSALAT)
2026년 7월 2일 업데이트: Chulalongkorn University
One-Month Dosing of Lemborexant for Treatment of Moderate OSA Patients With Low Arousal Threshold, a Randomized, Double-blind, Crossover, Placebo-Controlled Trial
The goal of this clinical trial is to investigate the 1-month treatment effects of different dose of lemborexant in moderate OSA adult patients (18-65 years of age) with low arousal threshold.
The main questions it aims to answer are:
Primary outcome measure: Apnea/hypopnea index (AHI)
Secondary outcome measure:
Polysomnography parameters
- Mean and nadir oxygen saturation
- Sleep efficiency
- Wake after sleep onset (WASO)
- Sleep latency
- Rapid eye movement (REM) latency
- Percentage of time spent in Non-rapid eye movement (NREM) stage 1-3 and REM stage
- Arousal index
- Oxford Sleep Resistance Test (OSLER) test
- Epworth Sleepiness Scale (ESS)
- Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T)
- Pittsburgh Sleep Quality Index (PSQI)
Actigraphy parameters
- Total sleep time
- Sleep efficiency
- Wake after sleep onset (WASO)
- Sleep latency
Sleep diary parameters (Appendix 5)
- Total sleep time
- Sleep efficiency
- Wake after sleep onset (WASO)
- Sleep latency
- Sleep quality
Researchers will compare placebo to see if there is a difference in AHI.
Participants will
- participate a total of 3 phases of study (3-crossover trial)
- each phrase the participants will receive either lemborexant 5 mg, lemborexant 10 mg, or placebo orally per day for 30 days with 2-week washout (depend on intervention arm whether the participants receive which intervention sequence)
- complete three overnight in-laboratory polysomnography (2-week washout) at day 30 of each phrase
- monitor actigraphy during day 1 to 29 of intervention of all periods
- record sleep diary during day 1 to 29 of intervention of all periods
- complete the OSLER test in the morning of the three overnight test
- complete questionnaires including: Epworth Sleepiness Scale (ESS), Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T), Pittsburgh Sleep Quality Index (PSQI) at baseline (prior to intervention) and the night before overnight in-laboratory polysomnography
연구 개요
상태
아직 모집하지 않음
개입 / 치료
- 의약품: Lemborexant 5 MG [Dayvigo] Period 1
- 의약품: Lemborexant 5 MG [Dayvigo] Period 2
- 의약품: Lemborexant 5 MG [Dayvigo] Period 3
- 의약품: Placebo Period 1
- 의약품: Placebo Period 2
- 의약품: Placebo Period 3
- 의약품: Lemborexant 10 MG [Dayvigo] Period 1
- 의약품: Lemborexant 10 MG [Dayvigo] Period 2
- 의약품: Lemborexant 10 MG [Dayvigo] Period 3
연구 유형
중재적
등록 (추정된)
36
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Sarocha Vivatvakin, MD
- 전화번호: 66879310233
- 이메일: sarocha.v@chula.ac.th
연구 연락처 백업
- 이름: Naricha Chirakalwasan, MD
- 전화번호: 662-649-4037
- 이메일: narichac@hotmail.com
연구 장소
-
-
Bangkok
-
Pathum Wan, Bangkok, 태국, 10330
- Chulalongkorn University
-
연락하다:
- Sarocha Vivatvakin, MD
- 전화번호: 66879310233
- 이메일: sarocha.v@chula.ac.th
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion criteria
Individuals are eligible for participation in this study if they have all of the followings:
- Patient, aged 18 - 65 years at the time of informed consent
- Voluntary agreement and capable for giving written informed consent
- Diagnosis with OSA according to the criteria of the International Classification of Sleep Disorders, version 3 Text Revision
- Baseline screening polysomnography (PSG) demonstrated apnea-hypopnea index 15 - 30 events/h of sleep (moderate severity)
- Patients identified as low arousal threshold using previously recommended criteria which allocated a score of 1 to each criterion: apnea-hypopnea index < 30 events per hour, nadir oxygen saturation as measured by pulse oximetry > 82.5%, and fraction of hypopneas > 58.3%. A score of 2 or above defined a low arousal threshold.
- Peripheral capillary oxygen saturation (SpO2) ≥ 94% measured during screening visit
- Habitually sleeping ≥ 5.5 hours/night with usual bedtime falls within the range of 9:00 PM to 1:00 AM
- Body mass index 18 - 40 kg/m2 Exclusion criteria
Individuals were not eligible for participation in this study if they have any of the followings:
- Previous allergy or adverse effects with Lemborexant or other sedatives
- Pregnant or breastfeeding
- Significant medical comorbidities that could affect individual safety and study assessment results, regarding investigators' opinion
- Uncontrolled cardiovascular or cerebrovascular diseases
- Neuromuscular diseases
- Nasal anatomical defect
- Significant psychiatric comorbidities that could affect individual safety and study assessment results, regarding investigators' opinion
- Active respiratory disorders other than OSA
- Central respiratory events (CAHI) >25% of the total AHI
- Diagnosis/symptoms of sleep-related disease other than OSA including narcolepsy, restless legs syndrome, periodic limb movement disorder, or circadian rhythm sleep-wake disorder
- Severe hypersomnolence (ESS ≥16)
- Peripheral capillary oxygen saturation (SpO2) < 80% for ≥ 5% of total sleep time measured during screening visit
- Driving-related sleepiness accident or near misses in the past 12 months
- Safety-critical occupation
- Using CPAP or other dental devices within 2 weeks of screening polysomnography until the end of the study
- Unable to tolerate equipment in this study
- Taking any medication that affects sleep or other variable measured in this study
- Taking any medication with cytochrome P450 Family 3A (CYP3A) inhibitors and all CYP3A inducers
- Drug or alcohol use disorder within 2 years before the study initiation or current excessive alcohol intake
- Excessive caffeine intake
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Lemborexant 5 mg
Participants will receive two treatment sequences.
Participants will complete three overnight sleep studies and cross-over with 2-week wash-out period The participants will receive lemborexant 5 mg per day before sleep for a total of 30 days.
On the day 30 participants will receive the lemborexant 5 mg 5 minutes before lights-out at the sleep laboratory for overnight polysomnography.
After 2 week wash-out period, the participants will cross to the placebo or lemborexant 10 mg arm with same repeat of another 2 phases.
|
Participants will receive lemborexant 5 mg per day for 30 days during first period
Participant will receive lemborexant 5 mg per day for 30 days during the second period
Participants will receive lemborexant 5 mg per day for 30 days during third period
|
|
위약 비교기: Placebo
Participants will receive two treatment sequences.
Participants will complete three overnight sleep studies and cross-over with 2-week wash-out period The participants will receive placebo per day before sleep for a total of 30 days.
On the day 30 participants will receive the placebo 5 minutes before lights-out at the sleep laboratory for overnight polysomnography.
After 2 week wash-out period, the participants will cross to the lemborexant 5 or 10 mg arm with same repeat of another 2 phases.
|
Participants will receive placebo 5 mg per day for 30 days during the first period
Participant will receive placebo 5 mg per day for 30 days during the second period
Participants will receive placebo per day for 30 days during third period
|
|
실험적: Lemborexant 10 mg
Participants will receive two treatment sequences.
Participants will complete three overnight sleep studies and cross-over with 2-week wash-out period The participants will receive lemborexant 10 mg per day before sleep for a total of 30 days.
On the day 30 participants will receive the lemborexant 10 mg 5 minutes before lights-out at the sleep laboratory for overnight polysomnography.
After 2 week wash-out period, the participants will cross to the placebo or lemborexant 5 mg arm with same repeat of another 2 phases.
|
Participants will receive lemborexant 10 mg per day for 30 days during first period
Participants will receive lemborexant 10 mg per day for 30 days during second period
Participants will receive lemborexant 10 mg per day for 30 days during third period
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Apnea/hypopnea index (AHI)
기간: At day 30 during the overnight in-laboratory of each study period
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Apnea/hypopnea index (AHI) measured by polysomnography (scale: events/hour: minimum 0 event/hour - no maximum scoring; higher scores mean worse outcome)
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At day 30 during the overnight in-laboratory of each study period
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean and nadir oxygen saturation
기간: At day 30 during the overnight in-laboratory of each study period
|
Mean and nadir oxygen saturation measured by polysomnography (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
|
At day 30 during the overnight in-laboratory of each study period
|
|
Sleep efficiency
기간: At day 30 during the overnight in-laboratory of each study period
|
Sleep efficiency measured by polysomnography (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
|
At day 30 during the overnight in-laboratory of each study period
|
|
Wake after sleep onset (WASO)
기간: At day 30 during the overnight in-laboratory of each study period
|
Wake after sleep onset (WASO) measured by polysomnography (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
|
At day 30 during the overnight in-laboratory of each study period
|
|
Sleep latency
기간: At day 30 during the overnight in-laboratory of each study period
|
Sleep latency measured by polysomnography (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
|
At day 30 during the overnight in-laboratory of each study period
|
|
REM latency
기간: At day 30 during the overnight in-laboratory of each study period
|
REM latency measured by polysomnography (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
|
At day 30 during the overnight in-laboratory of each study period
|
|
Percentage of time spent in NREM stage 1-3 and REM stage
기간: At day 30 during the overnight in-laboratory of each study period
|
Percentage of time spent in NREM stage 1-3 and REM stage measured by polysomnography (scale: percent: minimum 0% - maximum 100%; higher scores in NREM stage 3 and REM mean better outcome but higher scores in NREM stage 1 and 2 mean worse outcome)
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At day 30 during the overnight in-laboratory of each study period
|
|
Arousal index
기간: At day 30 during the overnight in-laboratory of each study period
|
Arousal index measured by polysomnography (scale: events/hour: minimum 0 event/hour - no maximum scoring; higher scores mean worse outcome)
|
At day 30 during the overnight in-laboratory of each study period
|
|
OSLER error index
기간: On the morning of the in-laboratory polysomnography
|
Oxford Sleep Resistance Test (OSLER) test (scale: events/hour: minimum 0 event/hour - no maximum scoring; higher scores mean worse outcome)
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On the morning of the in-laboratory polysomnography
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Epworth Sleepiness Scale (ESS)
기간: Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
|
Epworth Sleepiness Scale (ESS) questionnaires (scale: point: minimum 0 point - maximum 24 point; higher scores mean worse outcome)
|
Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
|
|
Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T)
기간: Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
|
Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T) (scale: point: minimum 5 point - maximum 20 point; higher scores mean better outcome)
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Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
|
|
Pittsburgh Sleep Quality Index
기간: Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
|
Pittsburgh Sleep Quality Index (scale: point: minimum 0 point - maximum 21 point; higher scores mean worse outcome)
|
Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
|
|
Total sleep time
기간: During day 1-29 of intervention
|
Total sleep time measured by actigraphy (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean better outcome)
|
During day 1-29 of intervention
|
|
Sleep efficiency
기간: During day 1-29 of intervention
|
Sleep efficiency measured by actigraphy (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
|
During day 1-29 of intervention
|
|
Wake after sleep onset (WASO)
기간: During day 1-29 of intervention
|
Wake after sleep onset (WASO) measured by actigraphy (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
|
During day 1-29 of intervention
|
|
Sleep latency
기간: During day 1-29 of intervention
|
Sleep latency measured by actigraphy (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
|
During day 1-29 of intervention
|
|
Total sleep time
기간: During day 1-29 of intervention
|
Total sleep time recorded by sleep diary (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean better outcome)
|
During day 1-29 of intervention
|
|
Sleep efficiency
기간: During day 1-29 of intervention
|
Sleep efficiency recorded by sleep diary (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
|
During day 1-29 of intervention
|
|
Wake after sleep onset (WASO)
기간: During day 1-29 of intervention
|
Wake after sleep onset (WASO) recorded by sleep diary (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
|
During day 1-29 of intervention
|
|
Sleep latency
기간: During day 1-29 of intervention
|
Sleep latency recorded by sleep diary (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
|
During day 1-29 of intervention
|
|
Sleep quality
기간: During day 1-29 of intervention
|
Sleep quality recorded by sleep diary (5-point Likert scale of 1-5; higher score mean better outcome)
|
During day 1-29 of intervention
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Sarocha Vivatvakin, MD, Department of Medicine, Faculty of Medicine
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2028년 6월 30일
연구 완료 (추정된)
2028년 6월 30일
연구 등록 날짜
최초 제출
2026년 6월 26일
QC 기준을 충족하는 최초 제출
2026년 7월 2일
처음 게시됨 (실제)
2026년 7월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 2일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 0594/69
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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예
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아니
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예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .