NCT05763329

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

A Randomized, Double-blind, Placebo-Controlled Trial on the Effects of Lemborexant as a Treatment for Moderate-to-severe OSA Patients With Low Arousal Threshold

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

Research Design A randomized, placebo-controlled, double-blind, crossover trial (1-week wash out period) comparing 1 night of 5 mg Lemborexant to placebo administered before sleep. Research Methodology Participants A total of 10 moderate to severe OSA patients with low arousal threshold are randomized 1:1 to either Lemborexant or placebo. The participants will complete two overnight in-laboratory polysomnography (1-week washout). Next-morning alertness will also be assessed using OSLER test, respectively. Inclusion criteria Eligible, healthy individuals with all the followings: * Untreated OSA patient 18 - 65 years of age * AHI ≥15 events/h of sleep * Low arousal threshold Study protocol All patients who were previously diagnosed with moderate to severe obstructive sleep apnea from baseline polysomnography with a low arousal threshold will be enrolled. The patients will be subsequently randomized 1:1 to one of the two treatment sequences. Participants will complete two overnight sleep studies and cross-over with 1-week wash-out period. Patients will receive either Lemborexant 5 mg per day or placebo prior 5 minutes before lights-out. During this 2-night polysomnography, sleep parameters will be analyzed including AHI, mean and nadir oxygen indices, sleep latency, sleep efficiency, wake after sleep onset (WASO), and percentage of time spent in NREM, stage 1-3 and REM stage. The OSLER test to define vigilance will be obtained on the following morning.

Conditions

• OSA

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-02-28
• Completion: 2025-06-30
• First posted: 2023-03-10
• Last updated: 2025-09-17

Locations

1 site across 1 country: Thailand

Regulatory

• FDA-regulated drug study