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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier:
NCT01361854
First received: May 26, 2011
Last updated: May 22, 2015
Last verified: May 2015
Results First Received: February 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Diagnostic
Condition: Sleep Disordered-breathing
Intervention: Device: polysomnography

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Home Hook-up First Then Hook-up in the Hospital

adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography

polysomnography: home-based polysomnography with hook-up performed at home first.

Croosover design. 2nd polysomnography with in-lab hook-up performed within 2 weeks

Hospital Hook-up First, Then Home Hook-up

adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography

polysomnography: home-based polysomnography with hook-up performed at the hospital Croosover design. 2nd polysomnography with home hook-up performed within 2 weeks


Participant Flow for 3 periods

Period 1:   Day 1
    Home Hook-up First Then Hook-up in the Hospital     Hospital Hook-up First, Then Home Hook-up  
STARTED     51     51  
COMPLETED     47     48  
NOT COMPLETED     4     3  

Period 2:   Wash-out, Maximum 2 Weeks
    Home Hook-up First Then Hook-up in the Hospital     Hospital Hook-up First, Then Home Hook-up  
STARTED     47     48  
COMPLETED     47     48  
NOT COMPLETED     0     0  

Period 3:   Second Intervention
    Home Hook-up First Then Hook-up in the Hospital     Hospital Hook-up First, Then Home Hook-up  
STARTED     47     48  
COMPLETED     47     48  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
patients suspected of OSA

Reporting Groups
  Description
Polysomnography for Suspicion of SDB

adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography

polysomnography: home-based polysomnography with hook-up performed ar at home or in the hospital


Baseline Measures
    Polysomnography for Suspicion of SDB  
Number of Participants  
[units: participants]
  102  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     102  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  48  (12)  
Gender  
[units: participants]
 
Female     32  
Male     70  
Region of Enrollment  
[units: participants]
 
Belgium     102  



  Outcome Measures

1.  Primary:   Failure Rate of Sleep Study   [ Time Frame: 1 day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Marie Bruyneel
Organization: CHU St Pierre
phone: 003225354219
e-mail: Marie_BRUYNEEL@stpierre-bru.be


No publications provided


Responsible Party: Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov 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