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

Primary Purpose

Sleep Apnea Syndromes, High Cardiovascular Risk

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
CPAP treatment
CPAP treatment
Sponsored by
Fédération Française de Pneumologie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea Syndromes focused on measuring Obstructive Sleep Apnea Syndrome, Apnea, Sleep Apnea, Telemedicine, CPAP compliance

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Respiratory physician in private practiceRecruiting
  • Respiratory physician in private practiceRecruiting
  • Respiratory physician in private practiceRecruiting
  • General HospitalRecruiting
  • General HospitalRecruiting
  • Dieulefit Santé ClinicRecruiting
  • Respiratory physician in private practiceRecruiting
  • Saint Vincent ClinicRecruiting
  • Respiratory physician in private practiceRecruiting
  • University HospitalRecruiting
  • Respiratory physician in private practiceRecruiting
  • University Hospital CalmetteRecruiting
  • La Louvière ClinicRecruiting
  • General HospitalRecruiting
  • Ambroise Paré HospitalRecruiting
  • Respiratory physician in private practiceRecruiting
  • General HospitalRecruiting
  • Les Rieux ClinicRecruiting
  • Respiratory physician in private practiceRecruiting
  • Hospital Bichat Claude BernardRecruiting
  • Respiratory physician in private practiceRecruiting
  • University HospitalRecruiting
  • Respiratory physician in private practiceRecruiting
  • Respiratory physician in private practiceRecruiting
  • Respiratory physician in private practiceRecruiting
  • General HospitalRecruiting
  • Respiratory physician in private practiceRecruiting
  • Respiratory physician in private practiceRecruiting
  • Respiratory physician in private practiceRecruiting
  • Respiratory physician in private practiceRecruiting
  • Tessier ClinicRecruiting
  • Hospital Nord OuestRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conventional

Telemedicine

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Objective CPAP compliance at 6 months
CPAP compliance assessed after 6 months in the two groups
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
Subjective Sleepiness
Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups
Fatigue
Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups
Quality of Life
Quality of life is assessed with SF-12 questionnaire at inclusion and month 6 in the two groups
Health status
Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups
Physical activity
Physical activity is assessed with actimetry at inclusion and month 6 in the two groups
Cost analysis
Cost analysis will include all key resources associated with the telemonitoring intervention and related health (referrals, consultations, resource use)

Full Information

First Posted
January 5, 2012
Last Updated
September 4, 2014
Sponsor
Fédération Française de Pneumologie
Collaborators
Federation of Medical Specialties
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1. Study Identification

Unique Protocol Identification Number
NCT01505959
Brief Title
Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 Study
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 Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fédération Française de Pneumologie
Collaborators
Federation of Medical Specialties

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes, High Cardiovascular Risk
Keywords
Obstructive Sleep Apnea Syndrome, Apnea, Sleep Apnea, Telemedicine, CPAP compliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
936 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional
Arm Type
Experimental
Arm Title
Telemedicine
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
CPAP treatment
Intervention Description
Usual CPAP treatment
Intervention Type
Device
Intervention Name(s)
CPAP treatment
Intervention Description
CPAP treatment with telemedicine system
Primary Outcome Measure Information:
Title
Systolic blood pressure evolution by comparing baseline and 6 months measurements
Description
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 Outcome Measure Information:
Title
Objective CPAP compliance at 6 months
Description
CPAP compliance assessed after 6 months in the two groups
Time Frame
day 0 and month 6
Title
Diastolic blood pressure evolution by comparing baseline and 6 months
Description
Diastolic blood pressure is assessed at day 0 and month 6 in the two groups
Time Frame
day 0 and month 6
Title
Subjective Sleepiness
Description
Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups
Time Frame
inclusion and month 6
Title
Fatigue
Description
Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups
Time Frame
inclusion and month 6
Title
Quality of Life
Description
Quality of life is assessed with SF-12 questionnaire at inclusion and month 6 in the two groups
Time Frame
inclusion and month 6
Title
Health status
Description
Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups
Time Frame
inclusion and month 6
Title
Physical activity
Description
Physical activity is assessed with actimetry at inclusion and month 6 in the two groups
Time Frame
inclusion and month 6
Title
Cost analysis
Description
Cost analysis will include all key resources associated with the telemonitoring intervention and related health (referrals, consultations, resource use)
Time Frame
month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Louis PEPIN, Prof, PhD
Phone
0033476765516
Email
JPepin@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Louis PEPIN, Prof, PhD
Organizational Affiliation
University Hospital, Grenoble, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Respiratory physician in private practice
City
Albertville
ZIP/Postal Code
73200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique LIGEONNET, MD
Facility Name
Respiratory physician in private practice
City
Annecy
ZIP/Postal Code
74000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François BON, MD
Facility Name
Respiratory physician in private practice
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc SAPENE, MD
First Name & Middle Initial & Last Name & Degree
François PELLET, MD
First Name & Middle Initial & Last Name & Degree
Laurent FALQUE, MD
First Name & Middle Initial & Last Name & Degree
Vincent PUEL, MD
First Name & Middle Initial & Last Name & Degree
Nathalie RAYMOND, MD
First Name & Middle Initial & Last Name & Degree
Christophe SUREAU, MD
Facility Name
General Hospital
City
Cannes
ZIP/Postal Code
06401
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe PERRIN, MD
Facility Name
General Hospital
City
Denain
ZIP/Postal Code
59225
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre GRIGNET, MD
Facility Name
Dieulefit Santé Clinic
City
Dieulefit
ZIP/Postal Code
26220
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric HERENGT, MD
Facility Name
Respiratory physician in private practice
City
Echirolles
ZIP/Postal Code
38130
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François ARBIB, MD
First Name & Middle Initial & Last Name & Degree
Nathalie CHOURI, MD
Facility Name
Saint Vincent Clinic
City
Epernay
ZIP/Postal Code
51200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric BONGRAIN, MD
Facility Name
Respiratory physician in private practice
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janie GIREY-RANNAUD, MD
Facility Name
University Hospital
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Louis PEPIN, Prof, PhD
First Name & Middle Initial & Last Name & Degree
Patrick LEVY, Prof, PhD
First Name & Middle Initial & Last Name & Degree
Renaud TAMISIER, MD
First Name & Middle Initial & Last Name & Degree
Natalia SIYANKO, MD
First Name & Middle Initial & Last Name & Degree
Sandrine LAUNOIS, MD
Facility Name
Respiratory physician in private practice
City
La Rochelle
ZIP/Postal Code
17000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric LE GUILLOU, MD
First Name & Middle Initial & Last Name & Degree
Claude GENDREAU, MD
Facility Name
University Hospital Calmette
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne MALLART, MD
First Name & Middle Initial & Last Name & Degree
Stéphanie FRY, MD
Facility Name
La Louvière Clinic
City
Lille
ZIP/Postal Code
59800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaut GENTINA, MD
First Name & Middle Initial & Last Name & Degree
Jean Marc DERNIS, MD
First Name & Middle Initial & Last Name & Degree
Catherine LAMBLIN, MD
First Name & Middle Initial & Last Name & Degree
Marc BURE, MD
First Name & Middle Initial & Last Name & Degree
François CODRON, MD
Facility Name
General Hospital
City
Magny en Vexin
ZIP/Postal Code
95420
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie NARES, MD
Facility Name
Ambroise Paré Hospital
City
Marseille
ZIP/Postal Code
13000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hervé PEGLIASCO, MD
Facility Name
Respiratory physician in private practice
City
Montigny les Metz
ZIP/Postal Code
57950
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique MULLER, MD
Facility Name
General Hospital
City
Montélimar
ZIP/Postal Code
26216
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique MARTINEAU, MD
First Name & Middle Initial & Last Name & Degree
Gilbert SALARD, MD
Facility Name
Les Rieux Clinic
City
Nyons
ZIP/Postal Code
26110
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabrielle VOTTERO, MD
First Name & Middle Initial & Last Name & Degree
Jorge Lucilo BENGOLEA, MD
First Name & Middle Initial & Last Name & Degree
Valérie MAYER, MD
First Name & Middle Initial & Last Name & Degree
Bernard PORSIN, MD
Facility Name
Respiratory physician in private practice
City
Nîmes
ZIP/Postal Code
30900
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier BENEZET, MD
Facility Name
Hospital Bichat Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Pia D'ORTHO, Prof, PhD
Facility Name
Respiratory physician in private practice
City
Reims
ZIP/Postal Code
51000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric MASURE, MD
Facility Name
University Hospital
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-François MUIR, Prof, PhD
Facility Name
Respiratory physician in private practice
City
Saint Etienne
ZIP/Postal Code
42100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique MOUNIER, MD
Facility Name
Respiratory physician in private practice
City
Saint Ismier
ZIP/Postal Code
38330
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique BERTRAND, MD
Facility Name
Respiratory physician in private practice
City
Six Fours Les Plages
ZIP/Postal Code
83140
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireille PADOVANI, MD
First Name & Middle Initial & Last Name & Degree
Gaël CHAIGNEAU, MD
Facility Name
General Hospital
City
St Avold
ZIP/Postal Code
57500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian KOLTES, MD
Facility Name
Respiratory physician in private practice
City
St Laurent du Var
ZIP/Postal Code
06700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy BOYER, MD
Facility Name
Respiratory physician in private practice
City
St Omer
ZIP/Postal Code
62500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe RICHARD, MD
Facility Name
Respiratory physician in private practice
City
Toulon
ZIP/Postal Code
83000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu LARROUSSE, MD
First Name & Middle Initial & Last Name & Degree
Catherine PACCHIONI, MD
First Name & Middle Initial & Last Name & Degree
Philippe SALLETTAZ, MD
Facility Name
Respiratory physician in private practice
City
Valence
ZIP/Postal Code
26000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves GRILLET, MD
First Name & Middle Initial & Last Name & Degree
Florence BOIS, MD
Facility Name
Tessier Clinic
City
Valenciennes
ZIP/Postal Code
59300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno STACH, MD
Facility Name
Hospital Nord Ouest
City
Villefranche Sur Saône
ZIP/Postal Code
69655
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel FALCHERO, MD

12. IPD Sharing Statement

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

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