Status:
NOT_YET_RECRUITING
Effects of Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty Sleeping
Lead Sponsor:
Flinders University
Conditions:
OSA - Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Detailed Description
Background: 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06928766
Start Date
May 1 2025
End Date
June 30 2027
Last Update
April 18 2025
Active Locations (1)
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1
Flinders University, Adelaide Institute for Sleep Health
Bedford Park, South Australia, Australia, 5042