Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 Study
1 other identifier
interventional
936
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2013
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2012
CompletedFirst Posted
Study publicly available on registry
January 9, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedSeptember 5, 2014
September 1, 2014
1.6 years
January 5, 2012
September 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
day 0 and month 6
Secondary Outcomes (8)
Objective CPAP compliance at 6 months
day 0 and month 6
Diastolic blood pressure evolution by comparing baseline and 6 months
day 0 and month 6
Subjective Sleepiness
inclusion and month 6
Fatigue
inclusion and month 6
Quality of Life
inclusion and month 6
- +3 more secondary outcomes
Study Arms (2)
Conventional
EXPERIMENTALTelemedicine
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Respiratory physician in private practice
Albertville, 73200, France
Respiratory physician in private practice
Annecy, 74000, France
Respiratory physician in private practice
Bordeaux, 33000, France
General Hospital
Cannes, 06401, France
General Hospital
Denain, 59225, France
Dieulefit Santé Clinic
Dieulefit, 26220, France
Respiratory physician in private practice
Échirolles, 38130, France
Saint Vincent Clinic
Épernay, 51200, France
Respiratory physician in private practice
Grenoble, 38000, France
University Hospital
Grenoble, 38000, France
Respiratory physician in private practice
La Rochelle, 17000, France
University Hospital Calmette
Lille, 59000, France
La Louvière Clinic
Lille, 59800, France
General Hospital
Magny-en-Vexin, 95420, France
Ambroise Paré Hospital
Marseille, 13000, France
General Hospital
Montélimar, 26216, France
Respiratory physician in private practice
Montigny-lès-Metz, 57950, France
Respiratory physician in private practice
Nîmes, 30900, France
Les Rieux Clinic
Nyons, 26110, France
Hospital Bichat Claude Bernard
Paris, 75018, France
Respiratory physician in private practice
Reims, 51000, France
University Hospital
Rouen, 76000, France
General Hospital
Saint-Avold, 57500, France
Respiratory physician in private practice
Saint-Etienne, 42100, France
Respiratory physician in private practice
Saint-Ismier, 38330, France
Respiratory physician in private practice
Saint-Laurent-du-Var, 06700, France
Respiratory physician in private practice
Saint-Omer, 62500, France
Respiratory physician in private practice
Six-Fours-les-Plages, 83140, France
Respiratory physician in private practice
Toulon, 83000, France
Respiratory physician in private practice
Valence, 26000, France
Tessier Clinic
Valenciennes, 59300, France
Hospital Nord Ouest
Villefranche-sur-Saône, 69655, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Louis PEPIN, Prof, PhD
University Hospital, Grenoble, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, PhD, Hospital Grenoble France
Study Record Dates
First Submitted
January 5, 2012
First Posted
January 9, 2012
Study Start
February 1, 2013
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
September 5, 2014
Record last verified: 2014-09