Effects of Lemborexant on Sleep Apnea
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
This study is testing if the sleep medication Lemborexant can improve sleep quality and alertness in people with moderate to severe sleep apnea.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Chulalongkorn University Academic / other |
| Locations | 1 site (Pathum Wan, Bangkok) |
| Trial ID | NCT05763329 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of Lemborexant, a medication, on patients with moderate to severe obstructive sleep apnea (OSA) who have a low arousal threshold. It is a randomized, placebo-controlled, double-blind, crossover trial involving two overnight polysomnography sessions with a one-week washout period. Participants will receive either Lemborexant or a placebo before sleep, and various sleep parameters will be assessed, including the apnea/hypopnea index and sleep efficiency. The study aims to determine how Lemborexant impacts sleep quality and alertness in these patients.
Who should consider this trial
Good fit: Ideal candidates are untreated adults aged 18 to 65 with moderate to severe OSA and a low arousal threshold.
Not a fit: Patients with other respiratory disorders, those using CPAP or dental devices, or individuals with uncontrolled comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and daytime alertness for patients with obstructive sleep apnea.
How similar studies have performed: While the specific use of Lemborexant in this context is novel, similar studies have shown promise in improving sleep parameters in OSA patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pathum Wan, Bangkok
- Chulalongkorn University — Pathum Wan, Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Sarocha Vivatvakin, MD — Department of Medicine, Faculty of Medicine, Chulalongkorn University
- Study coordinator: Sarocha Vivatvakin, MD
- Email: sarocha.v@chula.ac.th
- Phone: 66879310233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.