Telemedicine to Enhance Adherence to CPAP Therapy in Patients With OSAS

Study Overview
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Brief Summary
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We hypothesize that the use of telemedicine combined with support interventions by short messages, telephone calls and ambulatory visits to control CPAP treatment during the first month improves adherence and reduces unresolved side effects of therapy. The primary objective of an OSAS treatment program is to successfully implement indicated CPAP in the highest possible proportion of patients in order to lower the proportion of untreated OSAS in the population. On an individual basis, it has been shown that a longer duration of CPAP use is associated with better outcomes in terms of daytime functioning and in the control of metabolic and blood pressure effects of CPAP. For our study, we have therefore decided to use 2 co-primary endpoints, taking into account both aspects of adherence mentioned. Cardiovascular complications are a major concern in OSAS patients. Effective CPAP treatment has been shown to reduce surrogate measures of cardiovascular risk. We hypothesize that intensified efforts for CPAP adherence with telemedicine has a positive impact on a number of surrogate measures of the cardiovascular risk at 1 and 6 months of treatment.

Official Title
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Telemedicine to Enhance Adherence to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Syndrome; a Randomized Placebo-controlled Prospective Study

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Device: Telemedicine intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic OSAS patients with an AHI and an oxygen desaturation index (ODI) of >5/h in polysomnography (PSG) consenting to start longterm CPAP treatment. Exclusion Criteria: Age <18 years Unable to communicate in German, English, French or Italian Alcohol consumption > 4 units >4 times a week Acute manifestation of psychiatric diseases Life expectancy of < 6 months for any reason Surgical obesity treatment planned within the next 6 months Predominantly Central sleep apnea and cheyne stokes respiration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telemedicine intervention<br>In the telemedicine intervention arm, a telemetry device is instructed and attached to the CPAP. Patients are instructed to use CPAP every night. Data of the CPAP are downloaded to the internet once daily. On week days, a nurse is checking the downloaded data three times per week. The nurse contacts the patient if CPAP was used <4h/ night for 2 consecutive night the median leakage was above 0.4 L/sec on 2 consecutive nights The nurse informs the patient of the problem observed, asks for explanations and gives advice on possibilities to solve the problem. The common problems and the respective solutions are discussed according to the ELF facts sheet (Dry mouth/throat, nasal congestion, skin irritation, conjunctivitis, headache, loss of benefits, appendix 1). The patient is encouraged to use CPAP every night. In the case of regular use and acceptable leakage, a congratulatory message is sent to the patient via sms or e-mail (for procedural rules, see appendix 4). | Device: Telemedicine intervention<br>* Patients undergoing telemedicine intervention<br>* Other names: ResMed Telemedicine S9 Wireless-Modul;|
| No Intervention: Control (without telemedicine)<br>In the control arm, no device is attached to the CPAP machine, but data stored in the CPAP machine are collected at the follow-up visit after 1 month of CPAP use. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of nights with CPAP use (defined as ≥1h of CPAP use per night within the last month including nights of no-use of CPAP) at 6 months |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average nightly use of CPAP during the first 6 months of treatment (minutes per night including nights of no-use of CPAP since day 1) |  | at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSAS, CPAP, Adherence, Telemedicine