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Telemedicine for Sleep Apnea Patients (Respir@dom)

Primary Purpose

Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
With teletransmission
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sleep Apnea focused on measuring CPAP, adherence, SAOS, telemedicine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique - Hôpitaux de Paris, Béclère Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Without telemonitoring

With telemonitoring

Arm Description

Without teletransmission of alerts

With teletransmission of alerts

Outcomes

Primary Outcome Measures

CPAP adherence measured by the number of hours of nightly use

Secondary Outcome Measures

economics: cost estimation: investment and running costs
Quality of life
SF36 (french version) and FOSQ (Functional Outcomes of Sleep Questionnaire)
Organizational changes of home care providers and medical structures
Perception of healthcare professionals (autoquestionnaire RENEWING HEALTH)
Patients satisfaction

Full Information

First Posted
April 10, 2013
Last Updated
December 3, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01848509
Brief Title
Telemedicine for Sleep Apnea Patients
Acronym
Respir@dom
Official Title
A Telemedicine System for the Follow-up of Patients With SAS
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
CPAP, adherence, SAOS, telemedicine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Without telemonitoring
Arm Type
No Intervention
Arm Description
Without teletransmission of alerts
Arm Title
With telemonitoring
Arm Type
Experimental
Arm Description
With teletransmission of alerts
Intervention Type
Device
Intervention Name(s)
With teletransmission
Intervention Description
Teletransmission of alerts
Primary Outcome Measure Information:
Title
CPAP adherence measured by the number of hours of nightly use
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
economics: cost estimation: investment and running costs
Time Frame
3 months
Title
Quality of life
Description
SF36 (french version) and FOSQ (Functional Outcomes of Sleep Questionnaire)
Time Frame
3 months
Title
Organizational changes of home care providers and medical structures
Time Frame
9 months after the first patient inclusion
Title
Perception of healthcare professionals (autoquestionnaire RENEWING HEALTH)
Time Frame
3 months
Title
Patients satisfaction
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre ESCOURROU, MD, PhD
Organizational Affiliation
AP-HP - Antoine Béclère Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hôpitaux de Paris, Béclère Hospital
City
Clamart
ZIP/Postal Code
92141
Country
France

12. IPD Sharing Statement

Learn more about this trial

Telemedicine for Sleep Apnea Patients

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