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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

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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

Tracking Information
First Submitted Date  ICMJE February 15, 2013
First Posted Date  ICMJE February 22, 2013
Last Update Posted Date September 5, 2014
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
  • Subjective Sleepiness [ Time Frame: inclusion and month 6 ]
    Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups
  • Fatigue [ Time Frame: inclusion and month 6 ]
    Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Apnea Syndrome
  • Low Cardiovascular Risk
Intervention  ICMJE
  • Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
    Usual CPAP treatment in sleep apnea patients
  • Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
    CPAP treatment with telemedicine system
Study Arms  ICMJE
  • Experimental: Conventional
    Intervention: Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
  • Active Comparator: Telemedicine
    Intervention: Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 20, 2013)
936
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 78 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01796769
Other Study ID Numbers  ICMJE 11-FFPO-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jean Louis PEPIN, Fédération Française de Pneumologie
Study Sponsor  ICMJE Fédération Française de Pneumologie
Collaborators  ICMJE Federation of Medical Specialties
Investigators  ICMJE
Principal Investigator: Jean Louis PEPIN, Prof, PhD Functional Cardio-Respiratory Exploration Laboratory - University Hospital Grenoble - France
PRS Account Fédération Française de Pneumologie
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP