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

This study has been completed.
Information provided by (Responsible Party):
Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre Identifier:
First received: May 26, 2011
Last updated: May 22, 2015
Last verified: May 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 Intervention
Sleep Disordered-breathing
Device: polysomnography

Study Type: Interventional
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

Further study details as provided by Centre Hospitalier Universitaire Saint Pierre:

Primary Outcome Measures:
  • 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.

Enrollment: 102
Study Start Date: August 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: polysomnography for suspicion of SDB
adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
Device: polysomnography
home-based polysomnography with hook-up performed ar at home or in the hospital
Other Name: sleep study

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.


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • suspicion of other sleep disorders
  • children
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Please refer to this study by its identifier: NCT01361854

CHU Saint Pierre
Brussels, Belgium, 1000
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Principal Investigator: marie Bruyneel, MD CHU St Pierre
  More Information

No publications provided

Responsible Party: Marie Bruyneel, chest physician, Centre Hospitalier Universitaire Saint Pierre Identifier: NCT01361854     History of Changes
Other Study ID Numbers: AK/11-05-42/4024
Study First Received: May 26, 2011
Results First Received: February 20, 2015
Last Updated: May 22, 2015
Health Authority: Belgium: Ethics Committee

Keywords provided by Centre Hospitalier Universitaire Saint Pierre:
portable monitoring
sleep disordered breathing
home based polysomnography processed this record on October 07, 2015