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

September 4, 2014 updated by: Jean Louis PEPIN, Fédération Française de Pneumologie

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

936

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Albertville, France, 73200
        • Recruiting
        • Respiratory physician in private practice
        • Contact:
          • Dominique LIGEONNET, MD
      • Annecy, France, 74000
        • Recruiting
        • Respiratory physician in private practice
        • Contact:
          • François BON, MD
      • Bordeaux, France, 33000
        • Recruiting
        • Respiratory physician in private practice
        • Contact:
          • Marc SAPENE, MD
        • Sub-Investigator:
          • François PELLET, MD
        • Sub-Investigator:
          • Laurent FALQUE, MD
        • Sub-Investigator:
          • Vincent PUEL, MD
        • Sub-Investigator:
          • Nathalie RAYMOND, MD
        • Sub-Investigator:
          • Christophe SUREAU, MD
      • Cannes, France, 06401
        • Recruiting
        • General Hospital
      • Denain, France, 59225
        • Recruiting
        • General Hospital
        • Contact:
          • Jean-Pierre GRIGNET, MD
      • Dieulefit, France, 26220
        • Recruiting
        • Dieulefit Santé Clinic
        • Contact:
          • Frédéric HERENGT, MD
      • Echirolles, France, 38130
        • Recruiting
        • Respiratory physician in private practice
        • Contact:
          • François ARBIB, MD
        • Sub-Investigator:
          • Nathalie CHOURI, MD
      • Epernay, France, 51200
        • Recruiting
        • Saint Vincent Clinic
        • Contact:
          • Eric BONGRAIN, MD
      • Grenoble, France, 38000
        • Recruiting
        • University Hospital
        • Sub-Investigator:
          • Patrick LEVY, Prof, PhD
        • Sub-Investigator:
          • Natalia SIYANKO, MD
        • Sub-Investigator:
          • Sandrine LAUNOIS, MD
        • Contact:
          • Jean-Louis PEPIN, Prof, PhD
      • Grenoble, France, 38000
        • Recruiting
        • Respiratory physician in private practice
        • Contact:
          • Janie GIREY-RANNAUD, MD
      • La Rochelle, France, 17000
        • Recruiting
        • Respiratory physician in private practice
        • Contact:
          • Frédéric LE GUILLOU, MD
        • Sub-Investigator:
          • Claude GENDREAU, MD
      • Lille, France, 59000
        • Recruiting
        • University Hospital Calmette
        • Sub-Investigator:
          • Stéphanie FRY, MD
      • Lille, France, 59800
        • Recruiting
        • La Louvière Clinic
        • Contact:
          • Thibaut GENTINA, MD
        • Sub-Investigator:
          • Jean Marc DERNIS, MD
        • Sub-Investigator:
          • Catherine LAMBLIN, MD
        • Sub-Investigator:
          • Marc BURE, MD
        • Sub-Investigator:
          • François CODRON, MD
      • Magny en Vexin, France, 95420
        • Recruiting
        • General Hospital
        • Contact:
          • Sylvie NARES, MD
      • Marseille, France, 13000
        • Recruiting
        • Ambroise Paré Hospital
        • Contact:
          • Hervé PEGLIASCO, MD
      • Montigny les Metz, France, 57950
        • Recruiting
        • Respiratory physician in private practice
        • Contact:
          • Dominique MULLER, MD
      • Montélimar, France, 26216
        • Recruiting
        • General Hospital
        • Contact:
          • Dominique MARTINEAU, MD
        • Sub-Investigator:
          • Gilbert SALARD, MD
      • Nyons, France, 26110
        • Recruiting
        • Les Rieux Clinic
        • Contact:
          • Gabrielle VOTTERO, MD
        • Sub-Investigator:
          • Jorge Lucilo BENGOLEA, MD
        • Sub-Investigator:
          • Valérie MAYER, MD
        • Sub-Investigator:
          • Bernard PORSIN, MD
      • Nîmes, France, 30900
        • Recruiting
        • Respiratory physician in private practice
        • Contact:
          • Olivier BENEZET, MD
      • Paris, France, 75018
        • Recruiting
        • Hospital Bichat Claude Bernard
        • Contact:
          • Marie-Pia D'ORTHO, Prof, PhD
      • Reims, France, 51000
        • Recruiting
        • Respiratory physician in private practice
        • Contact:
          • Frédéric MASURE, MD
      • Rouen, France, 76000
        • Recruiting
        • University Hospital
        • Contact:
          • Jean-François MUIR, Prof, PhD
      • Saint Etienne, France, 42100
        • Recruiting
        • Respiratory physician in private practice
        • Contact:
          • Dominique MOUNIER, MD
      • Saint Ismier, France, 38330
        • Recruiting
        • Respiratory physician in private practice
        • Contact:
          • Dominique BERTRAND, MD
      • Six Fours Les Plages, France, 83140
        • Recruiting
        • Respiratory physician in private practice
        • Contact:
          • Mireille PADOVANI, MD
        • Sub-Investigator:
          • Gaël CHAIGNEAU, MD
      • St Avold, France, 57500
        • Recruiting
        • General Hospital
        • Contact:
          • Christian KOLTES, MD
      • St Laurent du Var, France, 06700
        • Recruiting
        • Respiratory physician in private practice
        • Contact:
          • Guy BOYER, MD
      • St Omer, France, 62500
        • Recruiting
        • Respiratory physician in private practice
        • Contact:
          • Philippe RICHARD, MD
      • Toulon, France, 83000
        • Recruiting
        • Respiratory physician in private practice
        • Contact:
          • Mathieu LARROUSSE, MD
        • Sub-Investigator:
          • Catherine PACCHIONI, MD
        • Sub-Investigator:
          • Philippe SALLETTAZ, MD
      • Valence, France, 26000
        • Recruiting
        • Respiratory physician in private practice
        • Contact:
          • Yves GRILLET, MD
        • Sub-Investigator:
          • Florence BOIS, MD
      • Valenciennes, France, 59300
        • Recruiting
        • Tessier Clinic
        • Contact:
          • Bruno STACH, MD
      • Villefranche Sur Saône, France, 69655
        • Recruiting
        • Hospital Nord Ouest
        • Contact:
          • Lionel FALCHERO, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Conventional
Device: CPAP treatment
Usual CPAP treatment
Device: CPAP treatment
CPAP treatment with telemedicine system
ACTIVE_COMPARATOR: Telemedicine
Device: CPAP treatment
Usual CPAP treatment
Device: CPAP treatment
CPAP treatment with telemedicine system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
day 0 and month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Sleepiness
Time Frame: inclusion and month 6
Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups
inclusion and month 6
Fatigue
Time Frame: inclusion and month 6
Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups
inclusion and month 6
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
inclusion and month 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
inclusion and month 6
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)
month 6
Objective CPAP compliance at 6 months
Time Frame: day 0 and month 6
CPAP compliance assessed after 6 months in the two groups
day 0 and month 6
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
day 0 and month 6
Physical activity
Time Frame: inclusion and month 6
Physical activity is assessed with actimetry at inclusion and month 6 in the two groups
inclusion and month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fédération Française de Pneumologie

Collaborators

Federation of Medical Specialties

Investigators

  • Principal Investigator: Jean Louis PEPIN, Prof, PhD, University Hospital, Grenoble, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ANTICIPATED)

September 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

January 6, 2012

First Posted (ESTIMATE)

January 9, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 5, 2014

Last Update Submitted That Met QC Criteria

September 4, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-FFPO-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Apnea Syndromes

Clinical Trials on CPAP treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe