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

• ClinicalTrials.gov Identifier: NCT01796769
• Recruitment Status: Unknown
• First Posted: February 22, 2013
• Last Update Posted: September 5, 2014
• Sponsor: Fédération Française de Pneumologie
• Collaborator: Federation of Medical Specialties
• Information provided by (Responsible Party): Jean Louis PEPIN, Fédération Française de Pneumologie

Tracking Information

• First Submitted Date: February 15, 2013
• First Posted Date: February 22, 2013
• Last Update Posted Date: September 5, 2014
• Study Start Date: February 2013
• Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 20, 2013)

Change from baseline CPAP compliance at 6 months [ Time Frame: day 0 and month 6 ]

CPAP compliance evolution by comparing baseline and 6 months measurements. CPAP compliance is assessed at month 6 in the two groups.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 20, 2013)

• Subjective Sleepiness [ Time Frame: inclusion and month 6 ]
  Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups
• Fatigue [ Time Frame: inclusion and month 6 ]
  Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups
• 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
• 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
• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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

Brief Summary

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.

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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Sleep Apnea Syndrome
• Low Cardiovascular Risk

Intervention

• Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
  Usual CPAP treatment in sleep apnea patients
• Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
  CPAP treatment with telemedicine system

Study Arms

• Experimental: Conventional
  Intervention: Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
• Active Comparator: Telemedicine
  Intervention: Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 20, 2013): 936
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2014
• Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 78 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01796769
• Other Study ID Numbers: 11-FFPO-01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jean Louis PEPIN, Fédération Française de Pneumologie
• Study Sponsor: Fédération Française de Pneumologie
• Collaborators: Federation of Medical Specialties

Investigators

• Principal Investigator: Jean Louis PEPIN, Prof, PhD; Functional Cardio-Respiratory Exploration Laboratory - University Hospital Grenoble - France

• PRS Account: Fédération Française de Pneumologie
• Verification Date: September 2014