We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Jean Louis PEPIN, Fédération Française de Pneumologie.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01505959
First Posted: January 9, 2012
Last Update Posted: September 5, 2014
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.
Collaborator:
Fédération des Spécialités Médicales
Information provided by (Responsible Party):
Jean Louis PEPIN, Fédération Française de Pneumologie
January 5, 2012
January 9, 2012
September 5, 2014
February 2013
September 2014   (Final data collection date for primary outcome measure)
Systolic blood pressure evolution by comparing baseline and 6 months measurements [ Time Frame: day 0 and month 6 ]
Systolic blood pressure is assessed at day 0 and month 6 in the two groups by home self-measured blood pressure (4 consecutive days)
Same as current
Complete list of historical versions of study NCT01505959 on ClinicalTrials.gov Archive Site
  • Objective CPAP compliance at 6 months [ Time Frame: day 0 and month 6 ]
    CPAP compliance assessed after 6 months in the two groups
  • Diastolic blood pressure evolution by comparing baseline and 6 months [ Time Frame: day 0 and month 6 ]
    Diastolic blood pressure is assessed at day 0 and month 6 in the two groups
  • 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
  • Physical activity [ Time Frame: inclusion and month 6 ]
    Physical activity is assessed with actimetry 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)
  • Objective CPAP compliance at 6 months [ Time Frame: day 0 and month 6 ]
    CPAP compliance assessed after 6 months in the two groups
  • Diastolic blood pressure evolution by comparing baseline and 6 months [ Time Frame: day 0 and month 6 ]
    Diastolic blood pressure is assessed at day 0 and month 6 in the two groups
  • 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
  • Physical activity [ Time Frame: inclusion and month 6 ]
    Physical activity is assessed with actimetry 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)
Not Provided
Not Provided
 
Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 Study
Blood Pressure Reduction Induced by Continuous Positive Airway Pressure (CPAP) in Sleep Apnea Patients at High Cardiovascular Risk : A Randomized Controlled Trial Comparing Usual CPAP Care Versus a Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform

Targeted population:

Sleep apnea patients at high cardiovascular risk newly treated by CPAP

Hypothesis:

Improvement in blood pressure after 6 months of CPAP treatment might be greater in the telemonitoring arm compared to usual CPAP care.

Main goal:

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

Study procedures:

The telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of home self-measured blood pressure, oximetry, physical activity recorded by actigraphy, 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 300 patients will be included.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Sleep Apnea Syndromes
  • High Cardiovascular Risk
  • Device: CPAP treatment
    Usual CPAP treatment
  • Device: CPAP treatment
    CPAP treatment with telemedicine system
  • Experimental: Conventional
    Intervention: Device: CPAP treatment
  • Active Comparator: Telemedicine
    Intervention: Device: CPAP treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
936
December 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 18 to 78 years
  • Men and women
  • AHI > 30 / hour
  • Patient with high cardiovascular score (>5% defined by European SCORE) or known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)
  • Patient affiliated to the National health insurance
  • Willingness to use a telemonitoring system

Exclusion Criteria:

  • Central sleep apnea syndrome
  • Previous CPAP treatment with respiratory support for sleep respiratory trouble
  • Cardiac failure with left ventricular ejection fraction lesser than 40%
  • Hypercapnic chronic respiratory failure (daytime PaCO2 > 50 mmHg)
  • Terminal disease
Sexes Eligible for Study: All
18 Years to 78 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01505959
11-FFPO-02
Yes
Not Provided
Not Provided
Jean Louis PEPIN, Fédération Française de Pneumologie
Fédération Française de Pneumologie
Fédération des Spécialités Médicales
Principal Investigator: Jean Louis PEPIN, Prof, PhD University Hospital, Grenoble, France
Fédération Française de Pneumologie
September 2014

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