RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Flinders University • ClinicalTrials.gov ID: NCT06928766

Registry updated: 2026-09-02

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Description

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).

Interventions

Eszopiclone 3 mg (Drug)
Both eszopiclone and lemborexant taken together at bedtime for one night
Placebo (Drug)
Placebo sugar pills that looks like the eszopiclone and lemborexant capsules taken at bedtime for one night.
Lemborexant 10mg (Drug)
Both eszopiclone and lemborexant taken together at bedtime for one night

Eligibility criteria

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

Conditions

OSA - Obstructive Sleep Apnea

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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