Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
|Official Title:||Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography|
- Failure Rate of Sleep Study [ Time Frame: 1 day ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2011|
|Study Completion Date:||November 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361854
|CHU Saint Pierre|
|Brussels, Belgium, 1000|
|Principal Investigator:||marie Bruyneel, MD||CHU St Pierre|