Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

2 juli 2026 uppdaterad av: 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

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

36

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Lemborexant 5 MG [Dayvigo] Period 1
Participants will receive lemborexant 5 mg per day for 30 days during first period
Läkemedel: Lemborexant 5 MG [Dayvigo] Period 2
Participant will receive lemborexant 5 mg per day for 30 days during the second period
Läkemedel: Lemborexant 5 MG [Dayvigo] Period 3
Participants will receive lemborexant 5 mg per day for 30 days during third period
Placebo-jämförare: 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.
Läkemedel: Placebo Period 1
Participants will receive placebo 5 mg per day for 30 days during the first period
Läkemedel: Placebo Period 2
Participant will receive placebo 5 mg per day for 30 days during the second period
Läkemedel: Placebo Period 3
Participants will receive placebo per day for 30 days during third period
Experimentell: 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.
Läkemedel: Lemborexant 10 MG [Dayvigo] Period 1
Participants will receive lemborexant 10 mg per day for 30 days during first period
Läkemedel: Lemborexant 10 MG [Dayvigo] Period 2
Participants will receive lemborexant 10 mg per day for 30 days during second period
Läkemedel: Lemborexant 10 MG [Dayvigo] Period 3
Participants will receive lemborexant 10 mg per day for 30 days during third period

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Apnea/hypopnea index (AHI)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean and nadir oxygen saturation
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Chulalongkorn University

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

30 juni 2028

Avslutad studie (Beräknad)

30 juni 2028

Studieregistreringsdatum

Först inskickad

26 juni 2026

Först inskickad som uppfyllde QC-kriterierna

2 juli 2026

Första postat (Faktisk)

6 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 juli 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 0594/69

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera