Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography

Not Applicable

Completed

• Conditions: Sleep Disordered-breathing

• Registration Number: NCT01361854
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

Brief Summary

Comparison of 2 hook-up protocols to perform home-based sleep studies in patients suspected of sleep-disordered breathing.

First one: hook-up is performed in the hospital, around 4 PM, and the patient go home with the portable monitoring.

Second one: hook-up is performed home, around 7 PM, and the patient has not to move after hook-up.

Detailed Description

All the patients will undergo 2 polysomnographies, according to two different hook-up protocols, within 2 weeks. Order of the exams will be randomized.

We hypothesised that quality of recording is better when hook-up is performed at home.

Final polysomnographic diagnosis, with the 2 different techniques, must be similar.

Study Timeline

• Study First Submitted: 2011-05-26
• Study First Submitted QC: 2011-05-26
• Study First Posted: 2011-05-27
• Study Start: 2011-08
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2015-02-20
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-22
• Last Update Submitted: 2015-05-22
• Results First Posted: 2015-06-08
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• adult,
• suspects of SDB,
• leaving home,
• at maximum 30km around the hospital

Exclusion Criteria

• suspicion of other sleep disorders
• children

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Failure Rate of Sleep Study	1 day	failure rate of polysomnography according to the hook-up protocol. Polysomnographies scored as "poor" or "unsatisafctory" according to Redline et al. SLEEP 1998 are considered as failed.

Trial Locations

Locations (1)

CHU Saint Pierre; 🇧🇪 Brussels, Belgium