Assessing the impact of short-course Zopiclone on Continuous Positive Away Pressure (CPAP) effectiveness for people with Obstructive Sleep Apnoea (OSA) who wake easily

Assessing the impact of a physiology-informed proof-of-concept study on OSA severity with CPAP therapy in people with a low respiratory arousal threshold (ZSTOPOSA)

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12625001009404

Enrollment

Registered

2025-09-11

Start date

2025-09-29

Completion date

2026-10-26

Last updated

2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Untreated obstructive sleep apnea (OSA) can lead to serious health, safety, and economic problems. Continuous Positive Airway Pressure (CPAP) therapy is the main treatment and it helps improve sleep quality and daytime alertness. However, about half of all people prescribed CPAP stop using it within the first year, often within the first month. Early interventions to make CPAP more effective can help improve health and quality of life. People with a low respiratory arousal threshold (who wake up easily due to minor airway narrowing) are at higher risk of not sticking with CPAP therapy. Cognitive Behavioural Therapy for Insomnia (CBTi) can help increase the arousal threshold and improve CPAP effectiveness, but it has limitations like the need for trained therapists and time commitment. Using common sleep (hypnotic) medications like zopiclone might be a cost-effective way to help promote sleep (increase the arousal threshold) and improve CPAP adherence. However, more research is needed to confirm the effectiveness of combining hypnotics with CPAP for people who wake up easily. The research project aims to test whether a medication that promotes sleep can help reduce the severity of OSA by improving the effectiveness of the first-line treatment for OSA, Continuous Positive Airway Pressure (CPAP).

Interventions

Zopiclone (7.5mg) each night for 4-weeks (30 days) in conjunction with CPAP initiation. Timing of dosage: To be taken within 30 minutes prior to CPAP initiation each night. Mode of administration: Oral tablet.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Participants must be aged 18 years and older with newly diagnosed OSA (AHI>10 or more events/hr) confirmed by polysomnography (PSG) scored using standard criteria. Participants must also have a low respiratory arousal threshold confirmed via in-laboratory or home-based (level 2) PSG. All participants will be untreated for their OSA and must be willing to try CPAP and take either zopiclone or placebo nightly for 1-month.

Exclusion criteria

Any medications known to effect sleep, breathing or muscle activity, pregnant or nursing mothers, any known allergy to zopiclone or previous adverse effects to zopiclone.

Outcome results