Back to resultsComparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography
Primary Purpose
Sleep Disordered-breathing
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
polysomnography
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep Disordered-breathing focused on measuring polysomnography, portable monitoring, sleep, sleep disordered breathing, home based polysomnography
Eligibility Criteria
Inclusion Criteria:
- adult,
- suspects of SDB,
- leaving home,
- at maximum 30km around the hospital
Exclusion Criteria:
- suspicion of other sleep disorders
- children
Sites / Locations
- CHU Saint Pierre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
polysomnography for suspicion of SDB
Arm Description
adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
Outcomes
Primary Outcome Measures
Failure Rate of Sleep Study
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01361854
First Posted
May 26, 2011
Last Updated
May 22, 2015
Sponsor
Centre Hospitalier Universitaire Saint Pierre
1. Study Identification
Unique Protocol Identification Number
NCT01361854
Brief Title
Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography
Official Title
Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disordered-breathing
Keywords
polysomnography, portable monitoring, sleep, sleep disordered breathing, home based polysomnography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
polysomnography for suspicion of SDB
Arm Type
Experimental
Arm Description
adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
Intervention Type
Device
Intervention Name(s)
polysomnography
Other Intervention Name(s)
sleep study
Intervention Description
home-based polysomnography with hook-up performed ar at home or in the hospital
Primary Outcome Measure Information:
Title
Failure Rate of Sleep Study
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult,
suspects of SDB,
leaving home,
at maximum 30km around the hospital
Exclusion Criteria:
suspicion of other sleep disorders
children
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
marie Bruyneel, MD
Organizational Affiliation
CHU St Pierre
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
12. IPD Sharing Statement
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Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography
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