Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography
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|ClinicalTrials.gov Identifier: NCT01361854|
Recruitment Status : Completed
First Posted : May 27, 2011
Results First Posted : June 8, 2015
Last Update Posted : June 8, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disordered-breathing||Device: polysomnography||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Experimental: polysomnography for suspicion of SDB
adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
home-based polysomnography with hook-up performed ar at home or in the hospital
Other Name: sleep study
- Failure Rate of Sleep Study [ Time Frame: 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361854
|CHU Saint Pierre|
|Brussels, Belgium, 1000|
|Principal Investigator:||marie Bruyneel, MD||CHU St Pierre|