Back to resultsReal-time Attended Home-polysomnography Through Telematic Data Transmission (sleepbox)
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
polysomnograph Dream and Sleep Box
Sponsored by
About this trial
This is an interventional diagnostic trial for Obstructive Sleep Apnea focused on measuring sleep apnea, polysomnography, telemedicine
Eligibility Criteria
Inclusion Criteria:
- clinical suspicion of OSA
- 18 y old
Exclusion Criteria:
- restrictive respiratory disorders
- distance home-hospital exceeding 30 Km.
Sites / Locations
- CHU St Pierre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
telematic attended polysomnography
Arm Description
Outcomes
Primary Outcome Measures
Quality of Polysomnographic Recordings
Quality of recordings will be graded according to Redline S et al (SLEEP 1998): Unsatisfactory, poor, fair, good, very good,excellent. Unsatisfactory and poor recordings are considered as failures.
Secondary Outcome Measures
Full Information
NCT ID
NCT01471626
First Posted
October 10, 2011
Last Updated
September 6, 2012
Sponsor
Centre Hospitalier Universitaire Saint Pierre
1. Study Identification
Unique Protocol Identification Number
NCT01471626
Brief Title
Real-time Attended Home-polysomnography Through Telematic Data Transmission
Acronym
sleepbox
Official Title
Real-time Attended Home-polysomnography Through Telematic Data Transmission
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2012 (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
The purpose of this study is to develop an efficient home-based polysomnography device, which allows, through GPRS,continuous real-time monitoring from the sleep lab based in the hospital, in order to decrease the failure rate of home-based recordings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
sleep apnea, polysomnography, telemedicine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
telematic attended polysomnography
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
polysomnograph Dream and Sleep Box
Intervention Description
Portable polysomnograph will be placed at home around 7:00PM. The Sleep Box (wireless monitoring device) will be left near the patient, to allow real-time GPRS transmission of recorded sleep parameters to the sleep lab.
Primary Outcome Measure Information:
Title
Quality of Polysomnographic Recordings
Description
Quality of recordings will be graded according to Redline S et al (SLEEP 1998): Unsatisfactory, poor, fair, good, very good,excellent. Unsatisfactory and poor recordings are considered as failures.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical suspicion of OSA
18 y old
Exclusion Criteria:
restrictive respiratory disorders
distance home-hospital exceeding 30 Km.
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 St Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Real-time Attended Home-polysomnography Through Telematic Data Transmission
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