Telemedicine for Sleep Apnea Patients

Sleep Apnea Clinical Trial

— Respir@dom  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848509
• Other study ID #: 2012-A00713-40
• Secondary ID: K120501
• Status: Completed
• Phase: N/A
• First received: April 10, 2013
• Last updated: December 3, 2014
• Start date: April 2013
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• With teletransmission
Teletransmission of alerts

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris, Béclère Hospital	Clamart

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPAP adherence measured by the number of hours of nightly use		3 Months	No
Secondary	economics: cost estimation: investment and running costs		3 months	No
Secondary	Quality of life	SF36 (french version) and FOSQ (Functional Outcomes of Sleep Questionnaire)	3 months	No
Secondary	Organizational changes of home care providers and medical structures		9 months after the first patient inclusion	No
Secondary	Perception of healthcare professionals (autoquestionnaire RENEWING HEALTH)		3 months	No
Secondary	Patients satisfaction		3 months	No