NCT06928766 Effects of Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty Sleeping
| NCT ID | NCT06928766 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Flinders University |
| Condition | OSA - Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-10-31 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 15 participants in total. It began in 2025-10-31 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Danny J Eckert, PhD
PRINCIPAL INVESTIGATOR
Flinders University
Frequently Asked Questions
Who can join the NCT06928766 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying OSA - Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06928766 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06928766 currently recruiting?
Yes, NCT06928766 is actively recruiting participants. Contact the research team at danny.eckert@flinders.edu.au for enrollment information.
Where is the NCT06928766 trial being conducted?
This trial is being conducted at Bedford Park, Australia.
Who is sponsoring the NCT06928766 clinical trial?
NCT06928766 is sponsored by Flinders University. The principal investigator is Danny J Eckert, PhD at Flinders University. The trial plans to enroll 15 participants.