A Randomized, Double-blind, Placebo-Controlled Trial on the Effects of Lemborexant as a Treatment for moderate-to-severe OSA Patients with Low Arousal Threshold

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210217004

Enrollment

Registered

2021-02-17

Start date

2024-10-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe OSA patients with low arousal threshold Apnea/Hypopnea Index (AHI) Lemborexant Obstructive Sleep Apnea (OSA) Low Arousal Threshold Polysomnography

Interventions

The patients will receive Lemborexant 5 mg per oral before go to sleep at the sleep laboratory for evaluation of previous mentioned sleep parameters, The patients will receive Placebo 5 mg per oral be

Experimental Drug,Placebo Comparator Drug

Lemborexant,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Eligible, healthy individuals with all the followings 1 Untreated OSA patient 2 AHI more than or equal to 15 events/h of sleep (moderate to severe) 3 Low arousal threshold was defined using previously recommended criteria which allocated a score of 1 to each criterion that was satisfied: (apnea-hypopnea index, less than 30 events per hour) + (nadir oxygen saturation as measured by pulse oximetry more than 82.5%) + (fraction of hypopneas more than 58.3%). A score of 2 or above defined a low arousal threshold

Exclusion criteria

Exclusion criteria: 1 Previous allergy or adverse effects with Lemborexant or other sedatives 2Taking any medication that affects sleep or other variable measured in this study 3 Pregnant or nursing mothers 4 Respiratory disorders other than OSA 5 Using CPAP or other dental devices 6 Unable to tolerate equipment in this study

Design outcomes

Primary

Measure	Time frame
AHI (apnea/hypopnea index) Intervention is given before the patient sleep, the outcome is measure during the same night AHI (apnea/hypopnea index) by polysomnography	—

Secondary

Measure	Time frame
Mean and nadir oxygen saturation Intervention is given before the patient sleep, the outcome is measure during the same night Mean and nadir oxygen saturation by pulse oximetry,Sleep latency Intervention is given before the patient sleep, the outcome is measure during the same night Sleep latency by polysomnography,Sleep efficiency Intervention is given before the patient sleep, the outcome is measure during the same night Sleep efficiency by polysomnography,Wake after sleep onset (WASO) Intervention is given before the patient sleep, the outcome is measure during the same night Wake after sleep onset (WASO) by polysomnography,Percentage of time spent in NREM stage 1-3 and REM stage Intervention is given before the patient sleep, the outcome is measure during the same night Percentage of time spent in NREM stage 1-3 and REM stage by polysomnography,Vigilance Intervention is given before the patient sleep, the outcome is measure at the next morning The Oxford Sleep Resistance (OSLER) Test	—

Measure

Time frame

Mean and nadir oxygen saturation Intervention is given before the patient sleep, the outcome is measure during the same night Mean and nadir oxygen saturation by pulse oximetry,Sleep latency Intervention is given before the patient sleep, the outcome is measure during the same night Sleep latency by polysomnography,Sleep efficiency Intervention is given before the patient sleep, the outcome is measure during the same night Sleep efficiency by polysomnography,Wake after sleep onset (WASO) Intervention is given before the patient sleep, the outcome is measure during the same night Wake after sleep onset (WASO) by polysomnography,Percentage of time spent in NREM stage 1-3 and REM stage Intervention is given before the patient sleep, the outcome is measure during the same night Percentage of time spent in NREM stage 1-3 and REM stage by polysomnography,Vigilance Intervention is given before the patient sleep, the outcome is measure at the next morning The Oxford Sleep Resistance (OSLER) Test

—

Countries

Thailand

Contacts

Public ContactSarocha Vivatvakin

Department of Medicine, Faculty of Medicine, Chulalongkorn University

sarocha.v@chula.ac.th66879310233

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026