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

Condition(s) studied

Investigational drug(s) / intervention(s)

Eszopiclone 3 mg: Both eszopiclone and lemborexant taken together at bedtime for one night

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

Lemborexant 10mg: Both eszopiclone and lemborexant taken together at bedtime for one night

Study 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

Primary outcome measure(s)

• Change in OSA severity (eszopiclone and lemborexant night vs. placebo night) — Two non-consecutive single night sleep studies (eszopiclone and lemborexant night vs. placebo night) up to one month apart.
  OSA severity as measured by the apnoea hypopnea index (units: number of respiratory events/h sleep) during overnight in-laboratory polysomnography.

Trial sites (1)

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