RecruitingPhase 2NCT06928766

Effects of Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty Sleeping

Effects of Eszopiclone and Lemborexant in People With Obstructive Sleep Apnoea (OSA) With a Low Arousal Threshold Who Have Difficulty Maintaining or Falling Asleep (ELOSA): A Double-blind, Placebo-controlled, Randomised, Trial.


Sponsor

Flinders University

Enrollment

15 participants

Start Date

Oct 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Insomnia and obstructive sleep apnoea (OSA) are very common conditions, collectively estimated to affect 2 billion people globally, and share many of the same symptoms. It is also common for people to have both insomnia and sleep apnoea (COMISA). Indeed, 30 to 40% of patients with chronic insomnia also fulfil the diagnostic criteria for OSA. These people can be particularly challenging to treat with conventional therapy approaches. People get OSA for different reasons. One key cause is waking up too easily to minor airway narrowing episodes (a low arousal threshold). Accordingly, this study aims to increase the arousal threshold using a combination approach with a GABAergic and an orexin agent in appropriately selected individuals (i.e., the clinically relevant group of people with OSA with a low arousal threshold and difficulty maintain or initiating sleep). Sleep, breathing and next day performance will be compared across two monitored overnight sleep studies (placebo vs the study drugs).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Eszopiclone 3 mg, a drug called Lemborexant 10mg, and others for people with osa - obstructive sleep apnea. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEszopiclone 3 mg

Both eszopiclone and lemborexant taken together at bedtime for one night

DRUGPlacebo

Placebo sugar pills that looks like the eszopiclone and lemborexant capsules taken at bedtime for one night.

DRUGLemborexant 10mg

Both eszopiclone and lemborexant taken together at bedtime for one night


Locations(1)

Flinders University, Adelaide Institute for Sleep Health

Bedford Park, South Australia, Australia

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NCT06928766


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