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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
Sponsor:
Information provided by (Responsible Party):
Marie Bruyneel, 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.


Condition or disease Intervention/treatment Phase
Sleep Disordered-breathing Device: polysomnography Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • suspicion of other sleep disorders
  • children

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361854


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

Responsible Party: Marie Bruyneel, chest physician, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT01361854     History of Changes
Other Study ID Numbers: AK/11-05-42/4024
First Posted: May 27, 2011    Key Record Dates
Results First Posted: June 8, 2015
Last Update Posted: June 8, 2015
Last Verified: May 2015

Keywords provided by Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre:
polysomnography
portable monitoring
sleep
sleep disordered breathing
home based polysomnography

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes