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).
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
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
Crossover
Eszopiclone 3 mg
DrugBoth eszopiclone and lemborexant taken together at bedtime for one night
Placebo
DrugPlacebo sugar pills that looks like the eszopiclone and lemborexant capsules taken at bedtime for one night.
Lemborexant 10mg
DrugBoth eszopiclone and lemborexant taken together at bedtime for one night
Change in OSA severity (eszopiclone and lemborexant night vs. placebo night)
OSA severity as measured by the apnoea hypopnea index (units: number of respiratory events/h sleep) during overnight in-laboratory polysomnography.
Change in nadir overnight hypoxemia (eszopiclone and lemborexant night vs. placebo night)
Nadir overnight oxygen saturation during sleep (units: %) measured via pulse oximetry during overnight in-laboratory polysomnography.
Change in mean overnight hypoxemia (eszopiclone and lemborexant night vs. placebo night)
Mean overnight oxygen saturation during sleep (units: %) measured via pulse oximetry during overnight in-laboratory polysomnography.
Change in time below 90% blood arterial oxygen saturation (eszopiclone and lemborexant night vs. placebo night)
Percent time asleep spent below an arterial oxygen saturation of 90% measured via pulse oximetry during overnight in-laboratory polysomnography.
Change in sleep efficiency (eszopiclone and lemborexant night vs. placebo night)
Percent time spent asleep divided by the recording time from lights out to lights on during overnight in-laboratory polysomnography
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