Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography
1 other identifier
interventional
102
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2011
CompletedFirst Posted
Study publicly available on registry
May 27, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
June 8, 2015
CompletedJune 8, 2015
May 1, 2015
3.3 years
May 26, 2011
February 20, 2015
May 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 day
Study Arms (1)
polysomnography for suspicion of SDB
EXPERIMENTALadults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography
Interventions
home-based polysomnography with hook-up performed ar at home or in the hospital
Eligibility Criteria
You may qualify if:
- adult,
- suspects of SDB,
- leaving home,
- at maximum 30km around the hospital
You may not qualify if:
- suspicion of other sleep disorders
- children
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Saint Pierre
Brussels, 1000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Marie Bruyneel
- Organization
- CHU St Pierre
Study Officials
- PRINCIPAL INVESTIGATOR
marie Bruyneel, MD
CHU St Pierre
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chest physician
Study Record Dates
First Submitted
May 26, 2011
First Posted
May 27, 2011
Study Start
August 1, 2011
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
June 8, 2015
Results First Posted
June 8, 2015
Record last verified: 2015-05