Telemedicine for Sleep Apnea Patients | NCT01848509

Studies
Telemedicine for Sleep Apnea Patients

NCT01848509

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Dec 4, 2014Estimated

Enrollment

201Actual

Phase

Not Applicable

Conditions

Sleep Apnea

Interventions

With teletransmission

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
K120501	Other Identifier	APHP - Clinical research department

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Apr 10, 2013

First Submission Date that Met QC Criteria

May 3, 2013

First Posted Date

May 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2014

Last Update Posted Date

Dec 4, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

201Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Without telemonitoring	No Intervention	Without teletransmission of alerts
With telemonitoring	Experimental	With teletransmission of alerts	Device: With teletransmission

Interventions

Name	Type	Description	Arm Group Labels	Other Names
With teletransmission	Device	Teletransmission of alerts	With telemonitoring

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CPAP adherence measured by the number of hours of nightly use		3 Months

Secondary Outcomes

Measure	Description	Time Frame
economics: cost estimation: investment and running costs		3 months
Quality of life	SF36 (french version) and FOSQ (Functional Outcomes of Sleep Questionnaire)	3 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre ESCOURROU, MD, PhD	AP-HP - Antoine Béclère Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique - Hôpitaux de Paris, Béclère Hospital		Clamart		92141	France

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided