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Not yet recruiting NCT07683442

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

Phase I / Phase II Interventional OSA - Obstructive Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lemborexant 5 MG [Dayvigo] Period 1, Placebo Period 1, Lemborexant 5 MG [Dayvigo] Period 2, Placebo Period 2.
Who it may be relevant to
Registry conditions: OSA - Obstructive Sleep Apnea. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Lemborexant 5 MG [Dayvigo] Period 1
    Participants will receive lemborexant 5 mg per day for 30 days during first period
  • Drug Placebo Period 1
    Participants will receive placebo 5 mg per day for 30 days during the first period
  • Drug Lemborexant 5 MG [Dayvigo] Period 2
    Participant will receive lemborexant 5 mg per day for 30 days during the second period
  • Drug Placebo Period 2
    Participant will receive placebo 5 mg per day for 30 days during the second period
  • Drug Lemborexant 5 MG [Dayvigo] Period 3
    Participants will receive lemborexant 5 mg per day for 30 days during third period
  • Drug Placebo Period 3
    Participants will receive placebo per day for 30 days during third period
  • Drug Lemborexant 10 MG [Dayvigo] Period 1
    Participants will receive lemborexant 10 mg per day for 30 days during first period
  • Drug Lemborexant 10 MG [Dayvigo] Period 2
    Participants will receive lemborexant 10 mg per day for 30 days during second period
  • Drug Lemborexant 10 MG [Dayvigo] Period 3
    Participants will receive lemborexant 10 mg per day for 30 days during third period

Primary outcome measures

  • Apnea/hypopnea index (AHI) [Time frame: At day 30 during the overnight in-laboratory of each study period]
Secondary outcome measures (12)
  • Mean and nadir oxygen saturation [Time frame: At day 30 during the overnight in-laboratory of each study period]
  • Sleep efficiency [Time frame: At day 30 during the overnight in-laboratory of each study period]
  • Wake after sleep onset (WASO) [Time frame: At day 30 during the overnight in-laboratory of each study period]
  • Sleep latency [Time frame: At day 30 during the overnight in-laboratory of each study period]
  • REM latency [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 [Time frame: At day 30 during the overnight in-laboratory of each study period]
  • Arousal index [Time frame: At day 30 during the overnight in-laboratory of each study period]
  • OSLER error index [Time frame: On the morning of the in-laboratory polysomnography]
  • 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]
  • 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]
  • 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]
  • Total sleep time [Time frame: During day 1-29 of intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • Chulalongkorn University — Pathum Wan

Identifiers

NCT: NCT07683442 · 0594/69

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗