The effects of zopiclone on obstructive sleep apnoea

Completed

• Conditions: Obstructive sleep apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12613001106729
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-03
• Last Update Posted: 13 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Men and women with obstructive sleep apnoea (OSA)

Exclusion Criteria

-People without OSA or who are currently on continuous positive airway pressure therapy for OSA
-People with high arousal thresholds (average nadir epiglottic pressure just prior to arousal <-25cmH2O) as determined by overnight polysomnogram (sleep study) during a screening visit.
-Known allergy or previous adverse reaction zopiclone
-Pregnant or nursing mothers

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine if zopiclone reduces the apnoea/hypopnoea index (AHI) via overnight polysomnographyin in sleep apnoea patients with low to moderate arousal thresholds[1 month]

Secondary Outcome Measures

Name	Time	Method
Symptoms of sleepiness as measured by standardized questionnaires (KSS, ESS, Leeds and FOSQ) [In the morning after Night 1 of the study intervention (KSS and Leeds) <br>In the evening before the study intervention at 1 month (KSS, ESS and FOSQ) and <br>The following morning after the study intervention at 1 month (KSS and Leeds)];AusEd driving simulator performance[Night 1 in the morning after the study intervention and 1 month in the morning after the study intervention];Other standard measures of sleep apnoea severity as determined during the polysomnogram (e.g. sleep efficiency, arousal index, event duration, nadir SaO2 and AHI on night 1)[Night 1 and 1 month, both after the study intervention]