Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 Study
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|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
Sleep apnea patients at high cardiovascular risk newly treated by CPAP
Improvement in blood pressure after 6 months of CPAP treatment might be greater in the telemonitoring arm compared to usual CPAP care.
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||936 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Device: CPAP treatment
Usual CPAP treatment
|Active Comparator: Telemedicine||
Device: CPAP treatment
CPAP treatment with telemedicine system
- 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)
- 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)
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
|Contact: Jean Louis PEPIN, Prof, PhD||0033476765516||JPepin@chu-grenoble.fr|
|Principal Investigator:||Jean Louis PEPIN, Prof, PhD||University Hospital, Grenoble, France|