Cooperative Research Centre (CRC) for Alertness, Safety and Productivity: Respiratory Phenotyping for Obstructive Sleep Apnea - Oxygen therapy in combination with Zopiclone

Phase 2

• Conditions: Obstructive Sleep Apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12615000858594
• Lead Sponsor: A/Prof Peter Catcheside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Diagnosed with obstructive sleep apnoea (OSA)
- Demonstrated partial treatment response to one night of oxygen therapy (defined as AHI being reduced by 50% or more on oxygen versus air, but AHI on oxygen still greater than or equal to 10/hour), as part of the study CRC Respiratory Phenotyping for Obstructive Sleep Apnea.

The current study is a sub-study of CRC Respiratory Phenotyping for Obstructive Sleep Apnea (ACTRN12615000918527).

Exclusion Criteria

- A history of significant COPD (gold criteria 3-4), chronic ventilatory failure from any other cause or psychiatric disorders likely to place the patient at a higher than normal risk or likely to confound experimental treatment outcomes.
- Age >65 years
- Pregnancy or nursing mother
- Any major contra-indication for Zopiclone (known hypersensitivity to Zopiclone or any of the excipients, prior or concomitant use of alcohol, myasthenia gravis, severe impairments of hepatic function and acute cerebrovascular accident).
- Physician recommended exclusion
- Patient unable (i.e. language difficulties) or unwilling to consent
- Central sleep apnoea (central apnea index >5 /hr)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apnoea-Hypopnoea Index (AHI) scored without conventional oxygen desaturation criteria and compared to baseline (diagnostic) sleep study scored with the same criteria. [AHI assessed without standard desaturation criteria will be measured from each overnight polysomnography study already conducted in preceding trials (baseline night, single night of O2 treatment alone, single night of air (control) treatment) compared to this trial intervention (single night of oxygen plus zopiclone). The current study is a sub-study of CRC Respiratory Phenotyping for Obstructive Sleep Apnea (ACTRN12615000918527).]