Trial intelligence / Profile preview

Zopiclone for CPAP Compliance in OSA

NCT01369576Phase 3

Key facts

Status: Completed
Start: May 2011
Primary completion: May 2014
Countries: 1
Sponsor: OSR Holdings
Modality: Small Molecules

Drugs: zopiclone
Conditions: obstructive sleep apnea (OSA)

Overview

Phase 3, randomised, double-blind trial in obstructive sleep apnea (OSA) comparing Zopiclone with Placebo (2 arms). Primary endpoint: CPAP adherence at 6 months. Started May 2011; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Zopiclone
Zopiclone 3.75-7.5mg (14 doses) + CPAP
Placebo
Placebo (14 doses) + CPAP

Who it enrols

Newly diagnosed OSA patients with no previous CPAP use and no concurrent hypnotic use. Excludes patients with fatal comorbidities, contraindications for CPAP, pregnancy, or liver failure.

Endpoints

Primary

CPAP adherence6 months

Secondary

Epworth Sleepiness Scale6 months
Calgary Sleep Apnea Quality of Life Index6 months
% time of average CPAP usage over the last month/ self-estimated total sleep time6 months
Residual Apnea-Hypopnea Index6 months

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