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Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 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: NCT01505959
Recruitment Status : Unknown
Verified September 2014 by Jean Louis PEPIN, Fédération Française de Pneumologie.
Recruitment status was:  Recruiting
First Posted : January 9, 2012
Last Update Posted : September 5, 2014
Sponsor:
Collaborator:
Federation of Medical Specialties
Information provided by (Responsible Party):
Jean Louis PEPIN, Fédération Française de Pneumologie

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes High Cardiovascular Risk Device: CPAP treatment Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 936 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
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

Arm Intervention/treatment
Experimental: Conventional Device: CPAP treatment
Usual CPAP treatment

Active Comparator: Telemedicine Device: CPAP treatment
CPAP treatment with telemedicine system




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Objective CPAP compliance at 6 months [ Time Frame: day 0 and month 6 ]
    CPAP compliance assessed after 6 months in the two groups

  2. 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

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

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

  5. 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

  6. 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

  7. Physical activity [ Time Frame: inclusion and month 6 ]
    Physical activity is assessed with actimetry at inclusion and month 6 in the two groups

  8. 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)



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.


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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 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

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): NCT01505959


Contacts
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Contact: Jean Louis PEPIN, Prof, PhD 0033476765516 JPepin@chu-grenoble.fr

Locations
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Sponsors and Collaborators
Fédération Française de Pneumologie
Federation of Medical Specialties
Investigators
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Principal Investigator: Jean Louis PEPIN, Prof, PhD University Hospital, Grenoble, France
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Responsible Party: Jean Louis PEPIN, Professor, PhD, Hospital Grenoble France, Fédération Française de Pneumologie
ClinicalTrials.gov Identifier: NCT01505959    
Other Study ID Numbers: 11-FFPO-02
First Posted: January 9, 2012    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
Apnea
Sleep Apnea
Telemedicine
CPAP compliance
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases