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The Optimal One-Month Dosing of Lemborexant for Moderate Obstructive Sleep Apnea (OSA) Patients With Low Arousal Threshold (LMOSALAT)

2. Juli 2026 aktualisiert von: 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:

  1. 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
  2. Oxford Sleep Resistance Test (OSLER) test
  3. Epworth Sleepiness Scale (ESS)
  4. Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T)
  5. Pittsburgh Sleep Quality Index (PSQI)

  6. Actigraphy parameters

    • Total sleep time
    • Sleep efficiency
    • Wake after sleep onset (WASO)
    • Sleep latency

  7. 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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

36

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Thailand
    • Bangkok
      • Pathum Wan, Bangkok, Thailand, 10330
        • Chulalongkorn University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion criteria

Individuals are eligible for participation in this study if they have all of the followings:

  1. Patient, aged 18 - 65 years at the time of informed consent
  2. Voluntary agreement and capable for giving written informed consent
  3. Diagnosis with OSA according to the criteria of the International Classification of Sleep Disorders, version 3 Text Revision
  4. Baseline screening polysomnography (PSG) demonstrated apnea-hypopnea index 15 - 30 events/h of sleep (moderate severity)
  5. 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.
  6. Peripheral capillary oxygen saturation (SpO2) ≥ 94% measured during screening visit
  7. Habitually sleeping ≥ 5.5 hours/night with usual bedtime falls within the range of 9:00 PM to 1:00 AM
  8. 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:

  1. Previous allergy or adverse effects with Lemborexant or other sedatives
  2. Pregnant or breastfeeding
  3. Significant medical comorbidities that could affect individual safety and study assessment results, regarding investigators' opinion
  4. Uncontrolled cardiovascular or cerebrovascular diseases
  5. Neuromuscular diseases
  6. Nasal anatomical defect
  7. Significant psychiatric comorbidities that could affect individual safety and study assessment results, regarding investigators' opinion
  8. Active respiratory disorders other than OSA
  9. Central respiratory events (CAHI) >25% of the total AHI
  10. Diagnosis/symptoms of sleep-related disease other than OSA including narcolepsy, restless legs syndrome, periodic limb movement disorder, or circadian rhythm sleep-wake disorder
  11. Severe hypersomnolence (ESS ≥16)
  12. Peripheral capillary oxygen saturation (SpO2) < 80% for ≥ 5% of total sleep time measured during screening visit
  13. Driving-related sleepiness accident or near misses in the past 12 months
  14. Safety-critical occupation
  15. Using CPAP or other dental devices within 2 weeks of screening polysomnography until the end of the study
  16. Unable to tolerate equipment in this study
  17. Taking any medication that affects sleep or other variable measured in this study
  18. Taking any medication with cytochrome P450 Family 3A (CYP3A) inhibitors and all CYP3A inducers
  19. Drug or alcohol use disorder within 2 years before the study initiation or current excessive alcohol intake
  20. Excessive caffeine intake

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: Lemborexant 5 MG [Dayvigo] Period 1
Participants will receive lemborexant 5 mg per day for 30 days during first period
Arzneimittel: Lemborexant 5 MG [Dayvigo] Period 2
Participant will receive lemborexant 5 mg per day for 30 days during the second period
Arzneimittel: Lemborexant 5 MG [Dayvigo] Period 3
Participants will receive lemborexant 5 mg per day for 30 days during third period
Placebo-Komparator: 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.
Arzneimittel: Placebo Period 1
Participants will receive placebo 5 mg per day for 30 days during the first period
Arzneimittel: Placebo Period 2
Participant will receive placebo 5 mg per day for 30 days during the second period
Arzneimittel: Placebo Period 3
Participants will receive placebo per day for 30 days during third period
Experimental: 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.
Arzneimittel: Lemborexant 10 MG [Dayvigo] Period 1
Participants will receive lemborexant 10 mg per day for 30 days during first period
Arzneimittel: Lemborexant 10 MG [Dayvigo] Period 2
Participants will receive lemborexant 10 mg per day for 30 days during second period
Arzneimittel: Lemborexant 10 MG [Dayvigo] Period 3
Participants will receive lemborexant 10 mg per day for 30 days during third period

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Apnea/hypopnea index (AHI)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean and nadir oxygen saturation
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Chulalongkorn University

Ermittler

  • Hauptermittler: Sarocha Vivatvakin, MD, Department of Medicine, Faculty of Medicine

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

30. Juni 2028

Studienabschluss (Geschätzt)

30. Juni 2028

Studienanmeldedaten

Zuerst eingereicht

26. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juli 2026

Zuerst gepostet (Tatsächlich)

6. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juli 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 0594/69

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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