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NCT01471626 Clinical Trial

Real-time Attended Home-polysomnography Through Telematic Data Transmission

Obstructive Sleep Apnea Clinical Trial

— sleepbox  

Official title:
Real-time Attended Home-polysomnography Through Telematic Data Transmission

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01471626
Other study ID # AK/-10-81/4077
Secondary ID
Status Completed
Phase N/A
First received October 10, 2011
Last updated September 6, 2012
Start date December 2011
Est. completion date March 2012

Study information
Verified date September 2012
Source Centre Hospitalier Universitaire Saint Pierre
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date March 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- clinical suspicion of OSA

- 18 y old

Exclusion Criteria:

- restrictive respiratory disorders

- distance home-hospital exceeding 30 Km.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• polysomnograph Dream and Sleep Box
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.

Locations
Country Name City State
Belgium CHU St Pierre Brussels

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 1 week No
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