Telemedicine for Sleep Apnea Patients (Respir@dom)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Sleep Apnea

Treatments: Device: With teletransmission

Study type: Interventional

Funder types: Other

Identifiers

NCT01848509

2012-A00713-40

K120501 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 2 patient groups

Without telemonitoring

No Intervention group

Description:

Without teletransmission of alerts

With telemonitoring

Experimental group

Description:

With teletransmission of alerts

Treatment:

Device: With teletransmission