Sleep Apnea Syndromes Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 936 |
Est. completion date | December 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 78 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Respiratory physician in private practice | Albertville | |
France | Respiratory physician in private practice | Annecy | |
France | Respiratory physician in private practice | Bordeaux | |
France | General Hospital | Cannes | |
France | General Hospital | Denain | |
France | Dieulefit Santé Clinic | Dieulefit | |
France | Respiratory physician in private practice | Echirolles | |
France | Saint Vincent Clinic | Epernay | |
France | Respiratory physician in private practice | Grenoble | |
France | University Hospital | Grenoble | |
France | Respiratory physician in private practice | La Rochelle | |
France | La Louvière Clinic | Lille | |
France | University Hospital Calmette | Lille | |
France | General Hospital | Magny en Vexin | |
France | Ambroise Paré Hospital | Marseille | |
France | General Hospital | Montélimar | |
France | Respiratory physician in private practice | Montigny les Metz | |
France | Respiratory physician in private practice | Nîmes | |
France | Les Rieux Clinic | Nyons | |
France | Hospital Bichat Claude Bernard | Paris | |
France | Respiratory physician in private practice | Reims | |
France | University Hospital | Rouen | |
France | Respiratory physician in private practice | Saint Etienne | |
France | Respiratory physician in private practice | Saint Ismier | |
France | Respiratory physician in private practice | Six Fours Les Plages | |
France | General Hospital | St Avold | |
France | Respiratory physician in private practice | St Laurent du Var | |
France | Respiratory physician in private practice | St Omer | |
France | Respiratory physician in private practice | Toulon | |
France | Respiratory physician in private practice | Valence | |
France | Tessier Clinic | Valenciennes | |
France | Hospital Nord Ouest | Villefranche Sur Saône |
Lead Sponsor | Collaborator |
---|---|
Fédération Française de Pneumologie | Fédération des Spécialités Médicales |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | Objective CPAP compliance at 6 months | CPAP compliance assessed after 6 months in the two groups | day 0 and month 6 | Yes |
Secondary | 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 | day 0 and month 6 | Yes |
Secondary | Subjective Sleepiness | Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups | inclusion and month 6 | Yes |
Secondary | Fatigue | Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups | inclusion and month 6 | Yes |
Secondary | Quality of Life | Quality of life is assessed with SF-12 questionnaire at inclusion and month 6 in the two groups | inclusion and month 6 | Yes |
Secondary | Health status | Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups | inclusion and month 6 | Yes |
Secondary | Physical activity | Physical activity is assessed with actimetry at inclusion and month 6 in the two groups | inclusion and month 6 | Yes |
Secondary | Cost analysis | Cost analysis will include all key resources associated with the telemonitoring intervention and related health (referrals, consultations, resource use) | month 6 | Yes |
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