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Taking peoplePhase 2

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
Australia1 site in 1 countryChoose a country to see its sites
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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

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.

Read full original descriptionShow less

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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