The Optimal One-Month Dosing of Lemborexant for Moderate Obstructive Sleep Apnea (OSA) Patients With Low Arousal Threshold (LMOSALAT)
2026年7月2日 更新者：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
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
36
段階
- フェーズ2
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Sarocha Vivatvakin, MD
- 電話番号：66879310233
- メール：sarocha.v@chula.ac.th
研究連絡先のバックアップ
- 名前：Naricha Chirakalwasan, MD
- 電話番号：662-649-4037
- メール：narichac@hotmail.com
研究場所
-
-
Bangkok
-
Pathum Wan、Bangkok、タイ、10330
- Chulalongkorn University
-
コンタクト：
- Sarocha Vivatvakin, MD
- 電話番号：66879310233
- メール：sarocha.v@chula.ac.th
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
|
プラセボコンパレーター：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
|
|
実験的：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Apnea/hypopnea index (AHI)
時間枠：At day 30 during the overnight in-laboratory of each study period
|
Apnea/hypopnea index (AHI) 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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean and nadir oxygen saturation
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
At day 30 during the overnight in-laboratory of each study period
|
|
Arousal index
時間枠：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
時間枠：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)
|
On the morning of the in-laboratory polysomnography
|
|
Epworth Sleepiness Scale (ESS)
時間枠：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)
時間枠：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)
|
Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
|
|
Pittsburgh Sleep Quality Index
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Sarocha Vivatvakin, MD、Department of Medicine, Faculty of Medicine
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2028年6月30日
研究の完了 (推定)
2028年6月30日
試験登録日
最初に提出
2026年6月26日
QC基準を満たした最初の提出物
2026年7月2日
最初の投稿 (実際)
2026年7月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月6日
QC基準を満たした最後の更新が送信されました
2026年7月2日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 0594/69
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。