Suspended

Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving Continuous Positive Airway Pressure (CPAP) Compliance in Low Cardiovascular Risk Sleep Apnea Patients

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What is being tested

Continuous Positive Airway Pressure (CPAP) in sleep apnea patients

+ Continuous Positive Airway Pressure (CPAP) in sleep apnea patients

Device
Who is being recruted

Treatment Adherence and Compliance+11

+ Apnea

+ Behavior

From 18 to 78 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorFédération Française de Pneumologie
Study ContactJean Louis PEPIN, Prof, PhDMore contacts
Last updated: September 5, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

Study procedures: The telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of oximetry, CPAP compliance, side effects and residual events. Secured data transmission to medical staff computers and secured websites will allow easy telemonitoring. Automatic algorithms have been built-up for early adjustment of CPAP treatment in case of side effects, leaks and persistent residual events. An interim analysis will be performed when 200 patients will be included.

NCT01796769
Principal SponsorFédération Française de Pneumologie
Study ContactJean Louis PEPIN, Prof, PhDMore contacts
Last updated: September 5, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

936 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 78 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Treatment Adherence and ComplianceApneaBehaviorNervous System DiseasesPatient Acceptance of Health CareRespiration DisordersRespiratory Tract DiseasesSleep Wake DisordersHealth BehaviorSleep Disorders, IntrinsicDyssomniasPatient ComplianceSleep Apnea SyndromesSleep Apnea, Obstructive

Criteria

6 inclusion criteria required to participate
AHI > 30 / hour
Age between 18 to 78 years
Men and women
Patient affiliated to the national health insurance
Show More Criteria
6 exclusion criteria prevent from participating
Cardiac failure
Central sleep apnea syndrome
Hypercapnic chronic respiratory failure (daytime PaCO2 > 50 mmHg)
Known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 32 locations

Recruiting

Respiratory physician in private practice

Albertville, FranceOpen Respiratory physician in private practice in Google Maps
Recruiting

Respiratory physician in private practice

Annecy, France
Recruiting

Respiratory physician in private practice

Bordeaux, France
Recruiting

General Hospital

Cannes, France
Suspended32 Study Centers