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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 bijgewerkt door: 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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

36

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Lemborexant 5 MG [Dayvigo] Period 1
Participants will receive lemborexant 5 mg per day for 30 days during first period
Geneesmiddel: Lemborexant 5 MG [Dayvigo] Period 2
Participant will receive lemborexant 5 mg per day for 30 days during the second period
Geneesmiddel: Lemborexant 5 MG [Dayvigo] Period 3
Participants will receive lemborexant 5 mg per day for 30 days during third period
Placebo-vergelijker: 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.
Geneesmiddel: Placebo Period 1
Participants will receive placebo 5 mg per day for 30 days during the first period
Geneesmiddel: Placebo Period 2
Participant will receive placebo 5 mg per day for 30 days during the second period
Geneesmiddel: Placebo Period 3
Participants will receive placebo per day for 30 days during third period
Experimenteel: 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.
Geneesmiddel: Lemborexant 10 MG [Dayvigo] Period 1
Participants will receive lemborexant 10 mg per day for 30 days during first period
Geneesmiddel: Lemborexant 10 MG [Dayvigo] Period 2
Participants will receive lemborexant 10 mg per day for 30 days during second period
Geneesmiddel: Lemborexant 10 MG [Dayvigo] Period 3
Participants will receive lemborexant 10 mg per day for 30 days during third period

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Apnea/hypopnea index (AHI)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean and nadir oxygen saturation
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Chulalongkorn University

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

30 juni 2028

Studie voltooiing (Geschat)

30 juni 2028

Studieregistratiedata

Eerst ingediend

26 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juli 2026

Eerst geplaatst (Werkelijk)

6 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juli 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 0594/69

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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