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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01361854
First Posted: May 27, 2011
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
May 26, 2011
May 27, 2011
February 20, 2015
June 8, 2015
June 8, 2015
August 2011
November 2014   (Final data collection date for primary outcome measure)
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.
quality of sleep study [ Time Frame: 2 weeks ]
quality of polysomnography according to the hook-up protocol
Complete list of historical versions of study NCT01361854 on ClinicalTrials.gov Archive Site
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Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Sleep Disordered-breathing
Device: polysomnography
home-based polysomnography with hook-up performed ar at home or in the hospital
Other Name: sleep study
Experimental: polysomnography for suspicion of SDB
adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
Intervention: Device: polysomnography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
November 2014
November 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • suspicion of other sleep disorders
  • children
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01361854
AK/11-05-42/4024
No
Not Provided
Not Provided
Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
Centre Hospitalier Universitaire Saint Pierre
Not Provided
Principal Investigator: marie Bruyneel, MD CHU St Pierre
Centre Hospitalier Universitaire Saint Pierre
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP