Telemonitoring of CPAP Therapy in Sleep Apnea Patients

Study Overview
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Brief Summary
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Wireless telemonitoring is compared with regular nursing procedure in terms of patient satisfaction, adherence to continuous positive pressure (CPAP) treatment and nursing time during the habituation phase of the CPAP therapy in obstructive sleep apnea syndrome (OSAS).

Detailed Description
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Both patients and study nurses were unblinded for the wireless telemonitoring system (ResTraxx™Online, ResMed, Sydney, Australia). The module was attached to the S9 Elite™ (ResMed, Sydney, Australia) CPAP device, which transmitted compliance data every day automatically to the ResTraxx™ Online (ResMed, Sydney, Australia) data base. The treatment was considered successful when CPAP use was >4 h/day, mask leak <0.4 L/s, and AHI <5/h during the last 6 days. Study nurses made the data check-ups daily during weekdays and if the criteria for successful CPAP therapy was not achieved during two consecutive nights the nurses adjusted the CPAP pressure remotely and called the patient to give further advice. Patients had also a control viist aftr one year.

Official Title
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Wireless Telemonitoring of Nasal CPAP Therapy in Sleep Apnea Patients

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Telemonitoring via wireless internet-based system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with diagnosed obstructive sleep apnea Exclusion Criteria: Not able to understand Finnish language Unable to co-operate

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
Interventional Model Description: The Ethics Committee approval was not required, since this study was part of our quality assurance procedure to revise the treatment protocol.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring<br>After CPAP titration, patients will be followed with telemonitoring device attached to the fixed pressure CPAP device | Device: Telemonitoring via wireless internet-based system<br> <br> |
| No Intervention: Usual care<br>Patients with fixed pressure CPAP will be followed according to routine protocol without telemonitoring | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nursing time | Nursing time of the TM group was estimated as follows: patient education regarding ResTraxx™ Online system (2 min), online data check-ups (0.5 min), remote changes for pressure settings (1 min), telephone guidance (5 min for the end of monitoring, 10 min for each extra call), visit at the study nurse (30- 60 min depending on type of visit), updating the patient records (2 min), and no show visits, which led to organizing a new appointment (20min). The time estimations are based on the measurements of the first 20 telemonitored patients. Nursing time in the UC Group was estimated with the same time calculations as in the TM group presented above with the exception of ttelemonitoring time which was not applicable in the UC group. | One year after the baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hours of CPAP use | Hours of CPAP use measured by the inbuilt counter of the CPAP device | One year after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea, CPAP treatment, telemedicine, nursing time, patient satisfaction