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NCT06928766: ELOSA
Effects of Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty Sleeping
Phase 2 trial testing Eszopiclone 3 mg in OSA - Obstructive Sleep Apnea in 15 participants. Not yet recruiting.
1 May 2027
Quick facts
| Lead sponsor | Flinders University |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 1 May 2025 |
| Primary completion | 1 May 2027 |
| Estimated completion | 30 June 2027 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- Eszopiclone 3 mg — full drug profile →
- Placebo
- Lemborexant 10mg — full drug profile →
Conditions studied
- OSA - Obstructive Sleep Apnea — all drugs for OSA - Obstructive Sleep Apnea →
Sponsor
Flinders University
Who can join
18 and older, any sex, with OSA - Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Advances in Non-CPAP Management of Obstructive Sleep Apnea: Spotlight on Pharmacological Therapies.
Siciliano M, de Scisciolo M, Fratini A, Sottani C, et al · · 2026 · PMID 41745396 · DOI 10.3390/jpm16020105
Verify or expand the search:
- PubMed search for NCT06928766
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Eszopiclone 3 mg
Trials testing the same drug.
- NCT07018557 — Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN) · Phase 4 · recruiting
- NCT06017921 — Effect of Eszopiclone on Adherence to CPAP and Severity of Insomnia in Patients With COMISA · Phase 4 · unknown
Other recruiting trials for OSA - Obstructive Sleep Apnea
Currently open trials in the same condition.
- NCT07434050 — A Study of XW003 in Obese Participants With Obstructive Sleep Apnea Receiving Positive Airway Pressure Therapy · Phase 3 · recruiting
- NCT07387094 — A Study of XW003 in Obese Participants With Obstructive Sleep Apnea But Not Receive Positive Airway Pressure Therapy · Phase 3 · recruiting
- NCT07376343 — Comparative Study of CPAP Predictive Equations and In-laboratory Manual Titration in Thai Patients With Obstructive Slee · recruiting
- NCT07082608 — Effect of Weight Loss From ESG Plus Lifestyle Changes vs. Lifestyle Changes Alone in Sleep Apnea Patients · NA · recruiting
- NCT07259200 — Impact of Atrial Fibrillation Ablation on Sleep Parameters. · recruiting
Other Flinders University trials
Trials by the same sponsor.
- NCT05527457 — BAY2586116 Nasal Spray and OSA Severity · Phase 1 · completed
- NCT05303935 — Effects of Quetiapine on Sleep and Next Day Alertness in People With Obstructive Sleep Apnea · Phase 2 · completed
- NCT05349058 — Assessment of Myocardial Injury in Patients Treated With Immune Checkpoint Inhibitors · unknown
- NCT04426578 — Role of Perhexiline in Hypertrophic Cardiomyopathy · Phase 2 · unknown
- NCT04128891 — Study of Sacubitril/ValsarTan on MyocardIal OxygenatioN and Fibrosis in Heart Failure With Preserved Ejection Fraction · Phase 3 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06928766 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Flinders University
- Last refreshed: 18 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06928766.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing