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

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. 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

Conditions

• OSA - Obstructive Sleep Apnea

Interventions

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

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

Sponsors & Collaborators

• Chulalongkorn University

  lead OTHER

Principal Investigators

• Sarocha Vivatvakin, MD · Department of Medicine, Faculty of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2028-06-30

Completion

2028-06-30

FDA Drug

Yes

Countries

• Thailand

Study Locations