drugset / Trial / NCT05763329

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

NCT05763329

Phase 1/2 Completed 10 enrolled Chulalongkorn University
RandomizedCrossoverDouble-blindTreatment

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

Timeline

Start
2023-02-01
Primary completion
2025-02-28
Completion
2025-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Lemborexant Small molecule 5 mg Oral