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

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).

NCT Number	NCT06928766
Lead Sponsor	Flinders University
Conditions	OSA - Obstructive Sleep Apnea
Enrollment	15 participants
Start Date	2025-05-01
Primary Completion	2027-05-01 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-04-18