OSA - Obstructive Sleep ApneaPhase 1/2LMOSALATNCT07683442
The Optimal One-Month Dosing of Lemborexant for Moderate Obstructive Sleep Apnea (OSA) Patients With Low Arousal Threshold
A Phase 1/2 study testing Lemborexant 5 MG [Dayvigo] Period 1, Lemborexant 5 MG [Dayvigo] Period 2 and Lemborexant 5 MG [Dayvigo] Period 3 in people with OSA - Obstructive Sleep Apnea, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- OSA - Obstructive Sleep Apnea
- What is being tested?
- Lemborexant 5 MG [Dayvigo] Period 1, Lemborexant 5 MG [Dayvigo] Period 2 and Lemborexant 5 MG [Dayvigo] Period 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2026to 30 Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 30Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Chulalongkorn University
Pathum Wan, Bangkok, 10330
Sarocha Vivatvakin, MD, 66879310233, sarocha.v@chula.ac.th
About this study
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
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:
Read more
Primary outcome measure: Apnea/hypopnea index (AHI)
Secondary outcome measure:
- 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
- Oxford Sleep Resistance Test (OSLER) test
- Epworth Sleepiness Scale (ESS)
- Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T)
- Pittsburgh Sleep Quality Index (PSQI)
- Actigraphy parameters
- Total sleep time
- Sleep efficiency
- Wake after sleep onset (WASO)
- Sleep latency
- 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
- Conditions
- OSA - Obstructive Sleep Apnea
- Being tested
- Lemborexant 5 MG [Dayvigo] Period 1, Placebo Period 1, Lemborexant 5 MG [Dayvigo] Period 2, Placebo Period 2, Lemborexant 5 MG [Dayvigo] Period 3
- Keywords
- Apnea/Hypopnea Index (AHI), Lemborexant, Obstructive Sleep Apnea (OSA), Low Arousal Threshold, Polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lemborexant 5 MG [Dayvigo] Period 1Drug
Participants will receive lemborexant 5 mg per day for 30 days during first period
Placebo Period 1Drug
Participants will receive placebo 5 mg per day for 30 days during the first period
Lemborexant 5 MG [Dayvigo] Period 2Drug
Participant will receive lemborexant 5 mg per day for 30 days during the second period
Placebo Period 2Drug
Participant will receive placebo 5 mg per day for 30 days during the second period
Lemborexant 5 MG [Dayvigo] Period 3Drug
Participants will receive lemborexant 5 mg per day for 30 days during third period
Placebo Period 3Drug
Participants will receive placebo per day for 30 days during third period
Lemborexant 10 MG [Dayvigo] Period 1Drug
Participants will receive lemborexant 10 mg per day for 30 days during first period
Lemborexant 10 MG [Dayvigo] Period 2Drug
Participants will receive lemborexant 10 mg per day for 30 days during second period
Lemborexant 10 MG [Dayvigo] Period 3Drug
Participants will receive lemborexant 10 mg per day for 30 days during third period
| Study group | Role | What they receive |
|---|---|---|
| Lemborexant 5 mg | Experimental | 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. Receives: Drug: Lemborexant 5 MG [Dayvigo] Period 1; Drug: Lemborexant 5 MG [Dayvigo] Period 2; Drug: Lemborexant 5 MG [Dayvigo] Period 3 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo Period 1; Drug: Placebo Period 2; Drug: Placebo Period 3 |
| Lemborexant 10 mg | Experimental | 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. Receives: Drug: Lemborexant 10 MG [Dayvigo] Period 1; Drug: Lemborexant 10 MG [Dayvigo] Period 2; Drug: Lemborexant 10 MG [Dayvigo] Period 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea/hypopnea index (AHI)
Apnea/hypopnea index (AHI) measured by polysomnography (scale: events/hour: minimum 0 event/hour - no maximum scoring; higher scores mean worse outcome)
Measured: At day 30 during the overnight in-laboratory of each study period
Secondary outcomes (20)
Mean and nadir oxygen saturation
Mean and nadir oxygen saturation measured by polysomnography (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
Measured: At day 30 during the overnight in-laboratory of each study period
Sleep efficiency
Sleep efficiency measured by polysomnography (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
Measured: At day 30 during the overnight in-laboratory of each study period
Wake after sleep onset (WASO)
Wake after sleep onset (WASO) measured by polysomnography (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
Measured: At day 30 during the overnight in-laboratory of each study period
Sleep latency
Sleep latency measured by polysomnography (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
Measured: At day 30 during the overnight in-laboratory of each study period
REM latency
REM latency measured by polysomnography (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
Measured: At day 30 during the overnight in-laboratory of each study period
Percentage of time spent in NREM stage 1-3 and REM stage
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)
Measured: At day 30 during the overnight in-laboratory of each study period
Arousal index
Arousal index measured by polysomnography (scale: events/hour: minimum 0 event/hour - no maximum scoring; higher scores mean worse outcome)
Measured: At day 30 during the overnight in-laboratory of each study period
OSLER error index
Oxford Sleep Resistance Test (OSLER) test (scale: events/hour: minimum 0 event/hour - no maximum scoring; higher scores mean worse outcome)
Measured: On the morning of the in-laboratory polysomnography
Epworth Sleepiness Scale (ESS)
Epworth Sleepiness Scale (ESS) questionnaires (scale: point: minimum 0 point - maximum 24 point; higher scores mean worse outcome)
Measured: 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)
Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T) (scale: point: minimum 5 point - maximum 20 point; higher scores mean better outcome)
Measured: Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (scale: point: minimum 0 point - maximum 21 point; higher scores mean worse outcome)
Measured: Baseline (prior to intervention) and at day 30 of intervention before the overnight in-laboratory of each study period
Total sleep time
Total sleep time measured by actigraphy (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean better outcome)
Measured: During day 1-29 of intervention
Sleep efficiency
Sleep efficiency measured by actigraphy (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
Measured: During day 1-29 of intervention
Wake after sleep onset (WASO)
Wake after sleep onset (WASO) measured by actigraphy (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
Measured: During day 1-29 of intervention
Sleep latency
Sleep latency measured by actigraphy (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
Measured: During day 1-29 of intervention
Total sleep time
Total sleep time recorded by sleep diary (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean better outcome)
Measured: During day 1-29 of intervention
Sleep efficiency
Sleep efficiency recorded by sleep diary (scale: percent: minimum 0% - maximum 100%; higher scores mean better outcome)
Measured: During day 1-29 of intervention
Wake after sleep onset (WASO)
Wake after sleep onset (WASO) recorded by sleep diary (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
Measured: During day 1-29 of intervention
Sleep latency
Sleep latency recorded by sleep diary (scale: minute: minimum 0 minute - no maximum scoring; higher scores mean worse outcome)
Measured: During day 1-29 of intervention
Sleep quality
Sleep quality recorded by sleep diary (5-point Likert scale of 1-5; higher score mean better outcome)
Measured: During day 1-29 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSA - Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarocha Vivatvakin, MD, Principal investigator, Department of Medicine, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683442
- Sponsor's protocol ID
- 0594/69
- Acronym
- LMOSALAT
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07683442
- Acronym / sponsor ID
- LMOSALAT / 0594/69
- Conditions
- OSA - Obstructive Sleep Apnea
- Keywords
- Apnea/Hypopnea Index (AHI), Lemborexant, Obstructive Sleep Apnea (OSA), Low Arousal Threshold, Polysomnography
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Oxford Sleep Resistance Test (OSLER) test
- Epworth Sleepiness Scale (ESS)
- Functional Outcome of Sleep Questionnaire-short version (FOSQ-10T)
- Pittsburgh Sleep Quality Index (PSQI)
- Actigraphy parameters
- Total sleep time
- Sleep efficiency
- Wake after sleep onset (WASO)
- Sleep latency
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lemborexant 5 mg | Experimental | Drug: Lemborexant 5 MG [Dayvigo] Period 1, Drug: Lemborexant 5 MG [Dayvigo] Period 2, Drug: Lemborexant 5 MG [Dayvigo] Period 3Participants 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. |
| Placebo | Placebo comparator | Drug: Placebo Period 1, Drug: Placebo Period 2, Drug: Placebo Period 3Participants 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. |
| Lemborexant 10 mg | Experimental | Drug: Lemborexant 10 MG [Dayvigo] Period 1, Drug: Lemborexant 10 MG [Dayvigo] Period 2, Drug: Lemborexant 10 MG [Dayvigo] Period 3Participants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lemborexant 5 MG [Dayvigo] Period 1Participants will receive lemborexant 5 mg per day for 30 days during first period | Drug | Lemborexant 5 mg |
| Placebo Period 1Participants will receive placebo 5 mg per day for 30 days during the first period | Drug | Placebo |
| Lemborexant 5 MG [Dayvigo] Period 2Participant will receive lemborexant 5 mg per day for 30 days during the second period | Drug | Lemborexant 5 mg |
| Placebo Period 2Participant will receive placebo 5 mg per day for 30 days during the second period | Drug | Placebo |
| Lemborexant 5 MG [Dayvigo] Period 3Participants will receive lemborexant 5 mg per day for 30 days during third period | Drug | Lemborexant 5 mg |
| Placebo Period 3Participants will receive placebo per day for 30 days during third period | Drug | Placebo |
| Lemborexant 10 MG [Dayvigo] Period 1Participants will receive lemborexant 10 mg per day for 30 days during first period | Drug | Lemborexant 10 mg |
| Lemborexant 10 MG [Dayvigo] Period 2Participants will receive lemborexant 10 mg per day for 30 days during second period | Drug | Lemborexant 10 mg |
| Lemborexant 10 MG [Dayvigo] Period 3Participants will receive lemborexant 10 mg per day for 30 days during third period | Drug | Lemborexant 10 mg |
Primary outcome
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)
20 secondary outcomes
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
Sleep efficiency
Time frame: During day 1-29 of intervention
Wake after sleep onset (WASO)
Time frame: During day 1-29 of intervention
Sleep latency
Time frame: During day 1-29 of intervention
Total sleep time
Time frame: During day 1-29 of intervention
Sleep efficiency
Time frame: During day 1-29 of intervention
Wake after sleep onset (WASO)
Time frame: During day 1-29 of intervention
Sleep latency
Time frame: During day 1-29 of intervention
Sleep quality
Time frame: During day 1-29 of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarocha Vivatvakin, MD principal investigator
Department of Medicine, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lemborexant 5 MG [Dayvigo] Period 1, Lemborexant 5 MG [Dayvigo] Period 2 and Lemborexant 5 MG [Dayvigo] Period 3 in people with OSA - Obstructive Sleep Apnea, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarocha Vivatvakin, MD (66879310233, sarocha.v@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea/hypopnea index (AHI) (time frame: At day 30 during the overnight in-laboratory of each study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.