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NCT Number: NCT07683442

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

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

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Key information

Conditions

OSA - Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lemborexant 5 MG [Dayvigo] Period 1

Drug

Participants will receive lemborexant 5 mg per day for 30 days during first period

Placebo Period 1

Drug

Participants will receive placebo 5 mg per day for 30 days during the first period

Lemborexant 5 MG [Dayvigo] Period 2

Drug

Participant will receive lemborexant 5 mg per day for 30 days during the second period

Placebo Period 2

Drug

Participant will receive placebo 5 mg per day for 30 days during the second period

Lemborexant 5 MG [Dayvigo] Period 3

Drug

Participants will receive lemborexant 5 mg per day for 30 days during third period

Placebo Period 3

Drug

Participants will receive placebo per day for 30 days during third period

Lemborexant 10 MG [Dayvigo] Period 1

Drug

Participants will receive lemborexant 10 mg per day for 30 days during first period

Lemborexant 10 MG [Dayvigo] Period 2

Drug

Participants will receive lemborexant 10 mg per day for 30 days during second period

Lemborexant 10 MG [Dayvigo] Period 3

Drug

Participants will receive lemborexant 10 mg per day for 30 days during third period

Primary outcomes

  1. Apnea/hypopnea index (AHI)

    Time frame: 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)

Secondary outcomes

  1. Mean and nadir oxygen saturation

    Time frame: 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)

  2. Sleep efficiency

    Time frame: 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)

  3. Wake after sleep onset (WASO)

    Time frame: 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)

  4. Sleep latency

    Time frame: 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)

  5. REM latency

    Time frame: 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)

  6. Percentage of time spent in NREM stage 1-3 and REM stage

    Time frame: 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)

  7. Arousal index

    Time frame: 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)

  8. OSLER error index

    Time frame: 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)

  9. Epworth Sleepiness Scale (ESS)

    Time frame: 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)

  10. Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T)

    Time frame: 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)

  11. Pittsburgh Sleep Quality Index

    Time frame: 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)

  12. Total sleep time

    Time frame: 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)

  13. Sleep efficiency

    Time frame: During day 1-29 of intervention

    Sleep efficiency measured by actigraphy (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)

  14. Wake after sleep onset (WASO)

    Time frame: 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)

  15. Sleep latency

    Time frame: During day 1-29 of intervention

    Sleep latency measured by actigraphy (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)

  16. Total sleep time

    Time frame: 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)

  17. Sleep efficiency

    Time frame: During day 1-29 of intervention

    Sleep efficiency recorded by sleep diary (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)

  18. Wake after sleep onset (WASO)

    Time frame: 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)

  19. Sleep latency

    Time frame: 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)

  20. Sleep quality

    Time frame: During day 1-29 of intervention

    Sleep quality recorded by sleep diary (5-point Likert scale of 1-5; higher score mean better outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Naricha Chirakalwasan, MD

CONTACT

[email protected]

662-649-4037

Sarocha Vivatvakin, MD

CONTACT

[email protected]

66879310233

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

One-Month Dosing of Lemborexant for Treatment of Moderate OSA Patients With Low Arousal Threshold, a Randomized, Double-blind, Crossover, Placebo-Controlled Trial

Acronym: LMOSALAT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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