Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving CPAP Compliance in Low Cardiovascular Risk Sleep Apnea Patients : OPTISAS 1 Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01796769
Recruitment Status : Unknown
Verified September 2014 by Jean Louis PEPIN, Fédération Française de Pneumologie.
Recruitment status was:  Recruiting
First Posted : February 22, 2013
Last Update Posted : September 5, 2014
Sponsor:
Collaborator:
Federation of Medical Specialties
Information provided by (Responsible Party):
Jean Louis PEPIN, Fédération Française de Pneumologie

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Targeted population:

Sleep apnea patients at low cardiovascular risk newly treated by CPAP

Hypothesis:

Six months CPAP compliance might be greater in the telemonitoring arm compared to usual CPAP care.

Main goal:

To compare 6-months CPAP compliance when Sleep Apnea patients at low cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.


Condition or disease Intervention/treatment Phase
Sleep Apnea Syndrome Low Cardiovascular Risk Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients Phase 4

Detailed Description:

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 936 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Conventional Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
Usual CPAP treatment in sleep apnea patients
Active Comparator: Telemedicine Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
CPAP treatment with telemedicine system


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change from baseline CPAP compliance at 6 months [ Time Frame: day 0 and month 6 ]
    CPAP compliance evolution by comparing baseline and 6 months measurements. CPAP compliance is assessed at month 6 in the two groups.


Secondary Outcome Measures :
  1. Subjective Sleepiness [ Time Frame: inclusion and month 6 ]
    Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups

  2. Fatigue [ Time Frame: inclusion and month 6 ]
    Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups

  3. Quality of Life [ Time Frame: inclusion and month 6 ]
    Quality of life is assessed with SF-12 questionnaire at inclusion and month 6 in the two groups

  4. Health status [ Time Frame: inclusion and month 6 ]
    Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups

  5. Cost analysis [ Time Frame: month 6 ]
    Cost analysis will include all key resources associated with the telemonitoring intervention and related health (referrals, consultations, resource use)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 to 78 years
  • Men and women
  • AHI > 30 / hour
  • Patient with low cardiovascular score (<5% defined by European SCORE)
  • Patient affiliated to the national health insurance
  • Willingness to use a telemonitoring system

Exclusion Criteria:

  • Known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)
  • Central sleep apnea syndrome
  • Previous CPAP treatment with respiratory support for sleep respiratory trouble
  • Cardiac failure
  • Hypercapnic chronic respiratory failure (daytime PaCO2 > 50 mmHg)
  • Terminal disease
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796769


Contacts
Layout table for location contacts
Contact: Jean Louis PEPIN, Prof, PhD 0033476765516 ext 65516 JPepin@chu-grenoble.fr

Locations
Show Show 32 study locations
Sponsors and Collaborators
Fédération Française de Pneumologie
Federation of Medical Specialties
Investigators
Layout table for investigator information
Principal Investigator: Jean Louis PEPIN, Prof, PhD Functional Cardio-Respiratory Exploration Laboratory - University Hospital Grenoble - France
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jean Louis PEPIN, Professor, PhD, Hospital Grenoble France, Fédération Française de Pneumologie
ClinicalTrials.gov Identifier: NCT01796769    
Other Study ID Numbers: 11-FFPO-01
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: September 2014
Keywords provided by Jean Louis PEPIN, Fédération Française de Pneumologie:
Obstructive Sleep Apnea Syndrome
Telemedicine
Patient Compliance
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases