Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving CPAP Compliance in Low Cardiovascular Risk Sleep Apnea Patients : OPTISAS 1 Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fédération des Spécialités Médicales
Information provided by (Responsible Party):
Jean Louis PEPIN, Fédération Française de Pneumologie
ClinicalTrials.gov Identifier:
NCT01796769
First received: February 15, 2013
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

Targeted population:

Sleep apnea patients at low cardiovascular risk newly treated by CPAP

Hypothesis:

Six months CPAP compliance might be greater in the telemonitoring arm compared to usual CPAP care.

Main goal:

To compare 6-months CPAP compliance when Sleep Apnea patients at low cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.


Condition Intervention Phase
Sleep Apnea Syndrome
Low Cardiovascular Risk
Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving Continuous Positive Airway Pressure (CPAP) Compliance in Low Cardiovascular Risk Sleep Apnea Patients

Resource links provided by NLM:


Further study details as provided by Fédération Française de Pneumologie:

Primary Outcome Measures:
  • Change from baseline CPAP compliance at 6 months [ Time Frame: day 0 and month 6 ] [ Designated as safety issue: Yes ]
    CPAP compliance evolution by comparing baseline and 6 months measurements. CPAP compliance is assessed at month 6 in the two groups.


Secondary Outcome Measures:
  • Subjective Sleepiness [ Time Frame: inclusion and month 6 ] [ Designated as safety issue: Yes ]
    Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups

  • Fatigue [ Time Frame: inclusion and month 6 ] [ Designated as safety issue: Yes ]
    Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups

  • Quality of Life [ Time Frame: inclusion and month 6 ] [ Designated as safety issue: Yes ]
    Quality of life is assessed with SF-12 questionnaire at inclusion and month 6 in the two groups

  • Health status [ Time Frame: inclusion and month 6 ] [ Designated as safety issue: Yes ]
    Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups

  • Cost analysis [ Time Frame: month 6 ] [ Designated as safety issue: Yes ]
    Cost analysis will include all key resources associated with the telemonitoring intervention and related health (referrals, consultations, resource use)


Estimated Enrollment: 936
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
Usual CPAP treatment in sleep apnea patients
Active Comparator: Telemedicine Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
CPAP treatment with telemedicine system

Detailed Description:

Study procedures:

The telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of oximetry, 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 200 patients will be included.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 to 78 years
  • Men and women
  • AHI > 30 / hour
  • Patient with low cardiovascular score (<5% defined by European SCORE)
  • Patient affiliated to the national health insurance
  • Willingness to use a telemonitoring system

Exclusion Criteria:

  • Known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)
  • Central sleep apnea syndrome
  • Previous CPAP treatment with respiratory support for sleep respiratory trouble
  • Cardiac failure
  • Hypercapnic chronic respiratory failure (daytime PaCO2 > 50 mmHg)
  • Terminal disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796769

Locations
France
Respiratory physician in private practice
Albertville, France, 73200
Respiratory physician in private practice
Annecy, France, 74000
Respiratory physician in private practice
Bordeaux, France, 33000
General Hospital
Cannes, France, 06401
General Hospital
Denain, France, 59225
Dieulefit Santé Clinic
Dieulefit, France, 26220
Respiratory physician in private practice
Echirolles, France, 38130
Saint Vincent Clinic
Epernay, France, 51200
University Hospital
Grenoble, France, 38000
Respiratory physician in private practice
Grenoble, France, 38100
Respiratory physician in private practice
La Rochelle, France, 17000
University Hospital Calmette
Lille, France, 59000
La Louvière Clinic
Lille, France, 59800
General Hospital
Magny en Vexin, France, 95420
Ambroise Paré Hospital
Marseille, France, 13000
Respiratory physician in private practice
Montigny les Metz, France, 57950
General Hospital
Montélimar, France, 26216
Les Rieux Clinic
Nyons, France, 26110
Respiratory physician in private practice
Nîmes, France, 30900
Hospital Bichat Claude Bernard
Paris, France, 75018
Respiratory physician in private practice
Reims, France, 51000
University Hospital
Rouen, France, 76000
Respiratory physician in private practice
Saint Etienne, France, 42100
Respiratory physician in private practice
Saint Ismier, France, 38330
Respiratory physician in private practice
Saint Omer, France, 62500
Respiratory physician in private practice
Six Fours Les Plages, France, 83140
General Hospital
St Avold, France, 57500
Respiratory physician in private practice
St Laurent du Var, France, 06700
Respiratory physician in private practice
Toulon, France, 83000
Respiratory physician in private practice
Valence, France, 26000
Tessier Clinic
Valenciennes, France, 59300
Hospital Nord Ouest
Villefranche Sur Saone, France, 69655
Sponsors and Collaborators
Fédération Française de Pneumologie
Fédération des Spécialités Médicales
Investigators
Principal Investigator: Jean Louis PEPIN, Prof, PhD Functional Cardio-Respiratory Exploration Laboratory - University Hospital Grenoble - France
  More Information

No publications provided

Responsible Party: Jean Louis PEPIN, Professor, PhD, Hospital Grenoble France, Fédération Française de Pneumologie
ClinicalTrials.gov Identifier: NCT01796769     History of Changes
Other Study ID Numbers: 11-FFPO-01
Study First Received: February 15, 2013
Last Updated: November 20, 2013
Health Authority: France: Ansm - French Health Products Safety Agency
France: The Commission nationale de l’informatique et des libertés

Keywords provided by Fédération Française de Pneumologie:
Obstructive Sleep Apnea Syndrome
Telemedicine
Patient Compliance

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2014