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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
  Purpose

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 (Investigator)
Primary Purpose: Diagnostic
Official Title: Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography

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

Primary Outcome Measures:
  • 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.


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.

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: May 26, 2011
First Posted: May 27, 2011
Results First Submitted: February 20, 2015
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