Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients

Study Overview
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Brief Summary
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The purpose of this study is to compare the effectiveness of telemonitoring versus standard follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS).

Detailed Description
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Obstructive Sleep Apnea (OSA) is defined by the presence of repetitive episodes of upper airways collapse during sleep, leading to nocturnal hypoxemia, sleep fragmentation and daytime sleepiness. When untreated, OSA is a risk factor for arterial hypertension , cardiovascular and cerebrovascular diseases, road accidents and a worse quality of life. The application of a continuous positive airways pressure (CPAP) represents the first line therapy in patients with moderate to severe OSA. CPAP treatment improves daytime sleepiness and oxygen saturation , reduces cardiovascular risk, ameliorates neurobehavioral performance, improves quality of life and reduces road accidents. Despite its demonstrated efficacy, CPAP effectiveness is significantly limited by poor adherence. A closer follow up could improve CPAP adherence but it would take up more work and additional costs for sleep units. So on that account, the investigators propose a study to demonstrate that automatic home treatment monitoring of patients with OSA is a cost-effectiveness alternative approach to patient's management. Moreover, the investigators believe that telemonitoring could improve CPAP compliance and patient's satisfaction and reduce follow-up costs. Methods: Prospective and randomized study during three months. Patients diagnosed as OSA in St. Maria's Hospital (Sleep Unit) and requiring CPAP treatment, will be randomized into two groups differing in CPAP compliance monitoring and management . Group 1 Standard care Patients will be fitted with a mask and given a CPAP and instructed on how to use the device. Patients will follow the standard treatment management. All patients will be visited at 1 month at sleep unit. Patients will be checked about progress and adherence to therapy and any problems with their machine. Information will be downloaded from their machines (CPAP adherence, applied CPAP pressure, mask leak, and residual respiratory events…). Group 2 Telemonitoring Patients will be fitted with a mask and given a CPAP. Each CPAP device will be provided with a modem sending daily compliance information (CPAP adherence, CPAP pressure, mask leak, and residual respiratory events) to a web database. Patients of both 2 groups will be finally visited at 3 months at sleep unit.

Official Title
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Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients

Conditions
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Sleep Apnea Syndrome

Intervention / Treatment
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* Other: Standard follow-up
* Other: Telemonitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and Women over 18 years old Diagnosed as OSA and requiring CPAP treatment Written informed consent form signed. Exclusion Criteria: Patients with impaired lung function (overlap syndrome, obesity hypoventilation syndrome, and restrictive disorders) Severe heart failure Severe chronic pathology associated Psychiatric disorder Periodic leg movements Pregnancy Other dyssomnias or parasomnias Patients already treated with CPAP

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard follow up-Sleep Unit<br>Patients diagnosed as OSA, treated with CPAP and followed up in sleep unit | Other: Standard follow-up<br>* Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.<br>|
| Experimental: Telemonitoring<br>Patients diagnosed as OSA and treated with CPAP in sleep unit, followed up by telemonitoring system | Other: Telemonitoring<br>* Follow up by telemonitoring system during 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP adherence at 3 months | Number of hours of use per day of CPAP according to the internal clock of the CPAP device | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' satisfaction at 3 months | Patients will be asked to grade their satisfaction with the follow up care provided by telemonitoring /sleep unit using a questionnaire and a visual analogue scale. | 3 months | 
| Cost effectiveness at 3 months | Costs in each group (CPAP carrying charge, number of visits and calls, number of hospital admissions) will be compared. | 3 months | 
| Change from baseline in quality of life at 3 months | EuroQOL health questionnaire and visual analogue scale will be used. | 3 months | 
| Fast detection of the non-adherent patient with telemonitoring | We assume that telemonitoring could quickly detect non- adherent patients. | 3 months | 
| Change in blood pressure at 3 months |  | 3 months | 
| Change in body mass index at 3 months |  | 3 months | 
| Abandons at 3 months | Number of patients lost at follow up at 3 months of CPAP therapy. | 3 months | 
| Adverse events at 3 months |  | 3 months | 
| Change from baseline in snoring at 3 months | Patients will be asked about the persistence of snoring | 3 months | 
| Change from baseline in witnessed apneas at 3 months | Patients will be asked about the persistence of witnessed apneas | 3 months | 
| Change from baseline in nocturia at 3 months | Patients will be asked about the presence of nocturia. | 3 months | 
| Change from baseline in daytime sleepiness at 3 months | Epworth sleepiness scale will be used. | 3 months | 
| Changes in nocturnal gasping at 3 months | Patients will be asked about the persistence of nocturnal gasping | 3 months | 
| Changes in sleep fragmentation at 3 months | Patients will be asked about the persistence of sleep fragmentation/maintenance insomnia | 3 months | 
| Presence of symptoms of restlees leg syndrome at 3 months | Patients will be asked about the presence of symptoms of restless leg syndrome | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPAP compliance, Telemonitoring, Standard management, Cost effectiveness