Benefits of Telemedicine in CPAP Treatment

Study Overview
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Brief Summary
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Continuous positive airway pressure (CPAP) is the first choice of treatment for moderate to severe obstructive sleep apnea syndrome (OSAS). Although adherence is critical for achieving a good treatment effect, and early intervention if treatment problems emerge is important for achieving good adherence, information on patient compliance is usually based on assessment of the first few weeks of treatment. Telemedicine technology allows for monitoring of CPAP pressure, air leaks, apnea-hypopnea index (AHI) and compliance on a daily basis and could therefore be an option allowing for adequate support and quick response if a patient has problems with the treatment. In addition, improving early experiences of CPAP, identifying patients in need of more intensive support could potentially improve adherence but also reduced cost of care, and increased patient satisfaction. The proposed study will recruit 200 OSAS patients starting CPAP treatment; 100 patients randomized to afterwards receiving telemonitoring in combination with telephone calls, and 100 patients randomized to receiving usual office visits. All patients will in addition answer questionnaires on sleep and health, quality of life, and patient satisfaction after the first CPAP information visit and then again after 6 months of treatment. At time of follow-up all patients will also answer questionnaires on side effects of CPAP. Health economic variables will also be measured throughout the testing period. The study will provide valuable information regarding benefits of telemonitoring in clinical work with CPAP therapy. Implementation of telemedicine-based monitoring of CPAP therapy may be an important part of increasing adherence among patients but also in the development of a more cost-effective care as it can provide clinics with increased treatment capacity and follow-up of both new and established patients. It would further improve the care for these patients who often have a lifelong treatment, which aims to reduce the risk of developing cardiovascular disease or premature death.

Official Title
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The Benefits of Telemedicine in CPAP Treatment of Obstructive Sleep Apnea Syndrome (OSAS)

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Other: Telemonitoring of CPAP treatment
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with OSA and scheduled to receive CPAP treatment Exclusion Criteria: Patients not understandning Swedish Patients not eligible for CPAP start within a group session.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Telemedicine<br>Patients randomized to receive telemonitoring in combination with telephone calls after CPAP start. | Other: Telemonitoring of CPAP treatment<br>* Telemedicine technology allows for monitoring of CPAP pressure, air leaks, apnea-hypopnea index (AHI) and compliance on a daily basis.<br>|
| Standard care<br>Patients randomized to receive usual office visits after CPAP start. | Other: Standard care<br>* Office visits and monitoring of CPAP treatment at each visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP adherence | Time of CPAP use at follow-up. Assesed from count in CPAP machine. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction regarding CPAP treatment and contact with clinic | Patient satisfaction regarding CPAP treatment and contact with clinic. Assessed via questionnaire. | 6 months | 
| Number of visits/contacts. | Number of visits/contacts. Assessed via hospital computer records. | 6 months | 
| Duration of visits/contacts. | Time duration of visits/contacs. Assessed via hospital computer records. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive sleep apnea, Continuous positive airway pressure, Telemoedicine