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
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| ClinicalTrials.gov Identifier: NCT01796769 |
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Recruitment Status : Unknown
Verified September 2014 by Jean Louis PEPIN, Fédération Française de Pneumologie.
Recruitment status was: Recruiting
First Posted : February 22, 2013
Last Update Posted : September 5, 2014
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Sleep Apnea Syndrome Low Cardiovascular Risk | Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients | Phase 4 |
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 (Clinical Trial) |
| Estimated Enrollment : | 936 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | February 2013 |
| Estimated Primary Completion Date : | September 2014 |
| Estimated Study Completion Date : | December 2014 |
| Arm | Intervention/treatment |
|---|---|
| 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 |
- 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.
- 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)
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| Ages Eligible for Study: | 18 Years to 78 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796769
| Contact: Jean Louis PEPIN, Prof, PhD | 0033476765516 ext 65516 | JPepin@chu-grenoble.fr |
Show 32 study locations
| Principal Investigator: | Jean Louis PEPIN, Prof, PhD | Functional Cardio-Respiratory Exploration Laboratory - University Hospital Grenoble - France |
| Responsible Party: | Jean Louis PEPIN, Professor, PhD, Hospital Grenoble France, Fédération Française de Pneumologie |
| ClinicalTrials.gov Identifier: | NCT01796769 |
| Other Study ID Numbers: |
11-FFPO-01 |
| First Posted: | February 22, 2013 Key Record Dates |
| Last Update Posted: | September 5, 2014 |
| Last Verified: | September 2014 |
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Obstructive Sleep Apnea Syndrome Telemedicine Patient Compliance |
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Apnea Sleep Apnea Syndromes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |