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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlinders University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Eszopiclone 3 mg
  • Placebo
  • Lemborexant 10mg

Treatment groups

15 Participants
are divided into 2 treatment groups

Sponsors and collaborators