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Effects of Lemborexant as a Treatment for Moderate-to-severe OSA Patients With Low Arousal Threshold

NCT05763329 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-09-17

No results posted yet for this study

Summary

The goal of this randomized, placebo-controlled, double-blind, crossover trial (1-week wash out period) is to compare 1 night of 5 mg Lemborexant to placebo administered before sleep in 10 moderate to severe OSA patients with low arousal threshold

The main questions it aims to answer are:

1. The effect of Lemborexant on apnea/hypopnea index (AHI) in moderate-to-severe OSA patients with low arousal threshold.
2. The effect of Lemborexant on the following parameters in moderate-to-severe OSA patients with low arousal threshold.

* Arousal threshold
* Mean and nadir oxygen saturation
* Sleep latency
* Sleep efficiency
* Wake after sleep onset (WASO)
* Percentage of time spent in NREM stage 1-3 and REM stage
* Stanford Sleepiness Scale Questionnaire in the morning
* The Oxford Sleep Resistance Test (OSLER) test

Participants will

* complete two overnight in-laboratory polysomnography (1-week washout)
* complete the OSLER test in the morning of the two overnight test

Researchers will compare with the placebo group to see if there is a difference in AHI

Conditions

  • OSA

Interventions

DRUG

Lemborexant 5 MG Oral Tablet [Dayvigo] Day 1

Patients will receive Lemborexant 5 mg per day on the first day of sleep test

DRUG

Lemborexant 5 MG Oral Tablet [Dayvigo] Day 2

Patients will receive Lemborexant 5 mg per day on the second day of sleep test

DRUG

Placebo Day 1

Patients will receive placebo on the first day of sleep test

DRUG

Placebo Day 2

Patients will receive placebo on the second day of sleep test

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2025-02-28
Completion
2025-06-30
FDA Drug
Yes

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05763329 on ClinicalTrials.gov