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

Fédération Française de Pneumologie936 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

936

Conditions

Sleep Apnea Syndromes High Cardiovascular Risk

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

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

Locations (32)

Respiratory physician in private practice

Albertville, France

RECRUITING

Respiratory physician in private practice

Annecy, France

RECRUITING

Respiratory physician in private practice

Bordeaux, France

RECRUITING

General Hospital

Cannes, France

Outcomes

Primary Outcomes

Systolic blood pressure evolution by comparing baseline and 6 months measurements

Systolic blood pressure is assessed at day 0 and month 6 in the two groups by home self-measured blood pressure (4 consecutive days)

Time frame: day 0 and month 6

Secondary Outcomes

Objective CPAP compliance at 6 months

CPAP compliance assessed after 6 months in the two groups

Time frame: day 0 and month 6

Diastolic blood pressure evolution by comparing baseline and 6 months

Diastolic blood pressure is assessed at day 0 and month 6 in the two groups

Time frame: day 0 and month 6

Subjective Sleepiness

Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups