Telemedicine for Sleep Apnea Patients (Respir@dom)

December 3, 2014 updated by: Assistance Publique - Hôpitaux de Paris

A Telemedicine System for the Follow-up of Patients With SAS

Objective: Set up an interoperable telemedicine system for the follow-up of patients with sleep apnea syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The medico-economics protocol will use the MAST (Methodology for Assessment of Telemedicine) criteria. 200 patients will be randomized into 2 arms (telemedicine with GPRS transmission of CPAP data from patients' home and classical follow-up) during the 3 first months of the follow-up. The main end-point is CPAP compliance with the aim of detecting a mean increase of at least 1hr in the use of CPAP.

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clamart, France, 92141
        • Assistance Publique - Hôpitaux de Paris, Béclère Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • AHI > 30/hr
  • hypersomnolence
  • agreement for the use of CPAP
  • internet and GSM connection

Exclusion Criteria:

  • central apnea >20%,
  • pneumothorax,
  • severe nasal obstruction,
  • previous pharyngeal surgery,
  • severe COPD,
  • heart failure,
  • previous use of CPAP,
  • no social security coverage,
  • unavailability,
  • no GSM and internet network

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Without telemonitoring
Without teletransmission of alerts
Experimental: With telemonitoring
With teletransmission of alerts
Device: With teletransmission
Teletransmission of alerts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CPAP adherence measured by the number of hours of nightly use
Time Frame: 3 Months
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
economics: cost estimation: investment and running costs
Time Frame: 3 months
3 months
Quality of life
Time Frame: 3 months
SF36 (french version) and FOSQ (Functional Outcomes of Sleep Questionnaire)
3 months
Organizational changes of home care providers and medical structures
Time Frame: 9 months after the first patient inclusion
9 months after the first patient inclusion
Perception of healthcare professionals (autoquestionnaire RENEWING HEALTH)
Time Frame: 3 months
3 months
Patients satisfaction
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Pierre ESCOURROU, MD, PhD, AP-HP - Antoine Béclère Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

April 10, 2013

First Submitted That Met QC Criteria

May 3, 2013

First Posted (Estimate)

May 7, 2013

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A00713-40
  • K120501 (Other Identifier: APHP - Clinical research department)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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