Effects of Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty Sleeping
Key facts
- Who runs it
- Flinders University
- Where
- Bedford Park, AustraliaSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 15 people, planned
- Started
- 31 Oct 2025
- Expected to end
- 30 Jun 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Eszopiclone 3 mg
- Placebo
- Lemborexant 10mg
- Record updated
- 2 September 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- Concomitant medications that interact or are contraindicated with eszopiclone, zopiclone, and Lemborexant
- Concomitant medications known to influence breathing, sleep, arousal, or muscle physiology
- Current or recent other medical conditions likely to affect results or safety
- Current pregnancy or breast-feeding
Where in Australia
- Flinders University, Adelaide Institute for Sleep HealthBedford Park, AustraliaContact: Reem Laboratory ManagerTaking people
About the trial
What the trial wants to find out
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.
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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).
The 2 groups in the trial
- Eszopiclone 3mg and lemborexant 10mgTreatment being tested
Both Eszopiclone 3mg and Lemborexant 10mg in the form of capsules taken before bedtime. Dosages is taken on one instance for one night only.
Treatment: Eszopiclone 3 mg and Lemborexant 10mg
- PlaceboPlacebo, for comparison
Placebo capsules that look exactly like the study drugs, taken before bedtime. Dosage is taken on one instance for one night only.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects of Eszopiclone and Lemborexant in People With Obstructive Sleep Apnoea (OSA) With a Low Arousal Threshold Who Have Difficulty Maintaining or Falling Asleep (ELOSA): A Double-blind, Placebo-controlled, Randomised, Trial.
- Record updated
- 2 September 2026