Effects of Lemborexant as a Treatment for Moderate-to-severe OSA Patients With Low Arousal Threshold
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lemborexant | Small molecule | 5 mg | Oral |