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

NCT05763329 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 218/64
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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:

• 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

Conditions

OSA

Keywords

Apnea/Hypopnea Index (AHI); Lemborexant; Obstructive Sleep Apnea (OSA); Low Arousal Threshold; Polysomnography

Outcome Measures

Primary Outcomes (1)

• apnea/hypopnea index (AHI)

  AHI

  through study completion, one week

Secondary Outcomes (6)

• Mean and nadir oxygen saturation

  through study completion, one week

• Sleep latency (Time the patients fall asleep)

  through study completion, one week

• Sleep efficiency (Time the patients actually sleep through out the experiment)

  through study completion, one week

• Wake after sleep onset (WASO)

  through study completion, one week

• Percentage of time spent in NREM stage 1-3 and REM stage

  through study completion, one week

Study Arms (2)

Lemborexant

EXPERIMENTAL

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.

Drug: Lemborexant 5 MG Oral Tablet [Dayvigo] Day 1; Drug: Placebo Day 2

Placebo

PLACEBO COMPARATOR

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.

Drug: Lemborexant 5 MG Oral Tablet [Dayvigo] Day 2; Drug: Placebo Day 1

Interventions

Lemborexant 5 MG Oral Tablet [Dayvigo] Day 1 DRUG

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

Lemborexant

Lemborexant 5 MG Oral Tablet [Dayvigo] Day 2 DRUG

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

Placebo

Placebo Day 1 DRUG

Patients will receive placebo on the first day of sleep test

Placebo

Placebo Day 2 DRUG

Patients will receive placebo on the second day of sleep test

Lemborexant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Apnea; Sleep Apnea, Obstructive

Interventions

lemborexant; Tablets

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Sarocha Vivatvakin, MD

  Department of Medicine, Faculty of Medicine, Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. Time of lights out was calculated from the median usual bedtime for each participant from the most recent 5 days (± 1 hour) and was kept constant between the two study nights. During this 2-night polysomnography, sleep parameters will be analyzed. The OSLER test to define vigilance will be obtained on the following morning.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 10, 2023
• Study Start: February 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: June 30, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)