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Telemedicine for Sleep Apnea Patients

NCT ID: NCT01848509

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Without telemonitoring

Without teletransmission of alerts

Group Type NO_INTERVENTION

No interventions assigned to this group

With telemonitoring

With teletransmission of alerts

Group Type EXPERIMENTAL

With teletransmission

Intervention Type DEVICE

Teletransmission of alerts

Interventions

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With teletransmission

Teletransmission of alerts

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre ESCOURROU, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AP-HP - Antoine Béclère Hospital

Locations

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Assistance Publique - Hôpitaux de Paris, Béclère Hospital

Clamart, , France

Site Status

Countries

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France

Other Identifiers

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K120501

Identifier Type: OTHER

Identifier Source: secondary_id

2012-A00713-40

Identifier Type: -

Identifier Source: org_study_id