Effects of Eszopiclone and Lemborexant in People with OSA and Low Arousal Threshold

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial examines whether adding a GABAergic sleep aid (eszopiclone) or an orexin antagonist (lemborexant), compared with placebo, improves sleep in adults with obstructive sleep apnea and a low arousal threshold who have difficulty maintaining or initiating sleep. Participants will undergo two overnight sleep studies to compare sleep and daytime performance across the different treatments. Eligible individuals have moderate to severe difficulty with sleep initiation/staying, an AHI of 10 or more, a low arousal threshold endotype, and BMI 35 or less. The trial is led by Flinders University in collaboration with the Adelaide Institute for Sleep Health, and excludes those taking interacting medications or with conditions likely to affect results or safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Moderate or more difficulty "staying or initiating asleep" score on the Insomnia Severity Index questionnaire
* Obstructive Sleep Apnoea (OSA), Apnoea Hypopnea Index ≥ 10 events/hour
* Low arousal respiratory threshold OSA endotype
* BMI ≤35 kg/m2

Exclusion Criteria:

* Concomitant medications that interact or are contraindicated with eszopiclone, zopiclone, and Lemborexant
* Concomitant medications known to influence breathing, sleep, arousal, or muscle physiology
* Current pregnancy or breast-feeding
* Current or recent other medical conditions likely to affect results or safety

Where it's running

• Flinders University, Adelaide Institute for Sleep Health
  Bedford Park, South Australia, Australia Recruiting

Study contacts

• Principal investigator: Danny J Eckert, PhD — Flinders University
• Study coordinator: Danny J Eckert, PhD
• Email: danny.eckert@flinders.edu.au
• Phone: +61 8 7421 9780

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.