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

RecruitingPhase 2Ages 18 Years - anyAllFlinders University
NCT06928766 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Eszopiclone 3 mg
  • Placebo
  • Lemborexant 10mg
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Where

1 site
Flinders University, Adelaide Institute for Sleep Health
Bedford Park, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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