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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
Results First Submitted: February 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (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 
Overall Participants Analyzed 
[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



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
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