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

NCT ID: NCT05763329

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lemborexant

Patients will receive two treatment sequences. Participants will complete two overnight sleep studies and cross-over with 1-week wash-out period The participants will receive Lemborexant 5 mg per day 5 minutes before lights-out for one dose for the first overnight sleep test of the experiment. After 1 week wash-out period, the participants will cross to the placebo arm and receive placebo 5 minutes before lights-out for one dose for the second overnight sleep test of the experiment.

Group Type: EXPERIMENTAL

Lemborexant 5 MG Oral Tablet [Dayvigo] Day 1

Intervention Type: DRUG

Patients will receive Lemborexant 5 mg per day on the first day of sleep test

Placebo Day 2

Intervention Type: DRUG

Patients will receive placebo on the second day of sleep test

Placebo

Patients will receive two treatment sequences. Participants will complete two overnight sleep studies and cross-over with 1-week wash-out period The participants will receive placebo 5 minutes before lights-out for one dose for the first overnight sleep test of the experiment. After 1 week wash-out period, the participants will cross to the Lemborexant arm and receive Lemborexant 5 mg per day 5 minutes before lights-out for one dose for the second overnight sleep test of the experiment.

Group Type: PLACEBO_COMPARATOR

Lemborexant 5 MG Oral Tablet [Dayvigo] Day 2

Intervention Type: DRUG

Patients will receive Lemborexant 5 mg per day on the second day of sleep test

Placebo Day 1

Intervention Type: DRUG

Patients will receive placebo on the first day of sleep test

Interventions

Lemborexant 5 MG Oral Tablet [Dayvigo] Day 1

Patients will receive Lemborexant 5 mg per day on the first day of sleep test

Intervention Type: DRUG

Lemborexant 5 MG Oral Tablet [Dayvigo] Day 2

Patients will receive Lemborexant 5 mg per day on the second day of sleep test

Intervention Type: DRUG

Placebo Day 1

Patients will receive placebo on the first day of sleep test

Intervention Type: DRUG

Placebo Day 2

Patients will receive placebo on the second day of sleep test

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarocha Vivatvakin, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Faculty of Medicine, Chulalongkorn University

Locations

Chulalongkorn University

Pathum Wan, Bangkok, Thailand

Countries

Thailand

Other Identifiers

218/64

Identifier Type: -

Identifier Source: org_study_id