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: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chulalongkorn University
• Treatments: Lemborexant

Criteria

Inclusion Criteria:

• Untreated OSA patient 18 - 65 years of age(49)

• AHI ≥15 events/h of sleep (moderate to severe)(23, 49)

• Low arousal threshold was defined using previously recommended criteria which allocated a score of 1 to each criterion that was satisfied: (apnea-hypopnea index, <30 events per hour) + (nadir oxygen saturation as measured by pulse oximetry >82.5%) + (fraction of hypopneas >58.3%). A score of 2 or above defined a low arousal threshold(50) (low arousal threshold defined as esophageal pressure values are 0 to -15 cmH2O)(27)

Exclusion Criteria:

• Previous allergy or adverse effects with Lemborexant or other sedatives - Taking any medication that affects sleep or other variable measured in this study - Pregnant or nursing mothers - Respiratory disorders other than OSA - Comorbid disease of poor controlled or resistant hypertension, uncontrolled cardiovascular or cerebrovascular disease

• Using CPAP or other dental devices

• Unable to tolerate equipment in this study