Telemedicine for Sleep Apnea Patients

Not Applicable

Completed

• Conditions: Sleep Apnea
• Interventions: Device: With teletransmission

• Registration Number: NCT01848509
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-07
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-03
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With telemonitoring	With teletransmission	With teletransmission of alerts

Primary Outcome Measures

Name	Time	Method
CPAP adherence measured by the number of hours of nightly use	3 Months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assistance Publique - Hôpitaux de Paris, Béclère Hospital; 🇫🇷 Clamart, France