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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Fédération Française de Pneumologie
Sponsor:
Collaborator:
Fédération des Spécialités Médicales
Information provided by (Responsible Party):
Jean Louis PEPIN, Fédération Française de Pneumologie
ClinicalTrials.gov Identifier:
NCT01505959
First received: January 5, 2012
Last updated: September 4, 2014
Last verified: September 2014

January 5, 2012
September 4, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Diastolic blood pressure is assessed at day 0 and month 6 in the two groups
  • Subjective Sleepiness [ Time Frame: inclusion and month 6 ] [ Designated as safety issue: Yes ]
    Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups
  • Fatigue [ Time Frame: inclusion and month 6 ] [ Designated as safety issue: Yes ]
    Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups
  • Quality of Life [ Time Frame: inclusion and month 6 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Physical activity is assessed with actimetry at inclusion and month 6 in the two groups
  • Cost analysis [ Time Frame: month 6 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Diastolic blood pressure is assessed at day 0 and month 6 in the two groups
  • Subjective Sleepiness [ Time Frame: inclusion and month 6 ] [ Designated as safety issue: Yes ]
    Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups
  • Fatigue [ Time Frame: inclusion and month 6 ] [ Designated as safety issue: Yes ]
    Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups
  • Quality of Life [ Time Frame: inclusion and month 6 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Physical activity is assessed with actimetry at inclusion and month 6 in the two groups
  • Cost analysis [ Time Frame: month 6 ] [ Designated as safety issue: Yes ]
    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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
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
Both
18 Years to 78 Years
No
Contact: Jean Louis PEPIN, Prof, PhD 0033476765516 JPepin@chu-grenoble.fr
France
 
NCT01505959
11-FFPO-02
Yes
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