Effects of Lemborexant as a Treatment for Moderate-to-severe OSA Patients With Low Arousal Threshold
Status:
Recruiting
Trial end date:
2025-05-01
Target enrollment:
Participant gender:
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
20 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), with esophageal
pressure catheter placement and standard polysomnography monitoring
- complete the Stanford Sleepiness Scale Questionnaire and 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