Telemonitoring in CPAP Treatment

Study Overview
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Brief Summary
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Wireless telemonitoring was used during the habituation phase of continuous positive airway pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing time, patient satisfaction and treatment efficiency and efficacy were compared between the groups at baseline and after one year treatment the CPAP adherence and treatment efficacy were recorded.

Detailed Description
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Wireless telemonitoring was used during the habituation phase of continuous positive airway pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing time, patient satisfaction and treatment efficiency and efficacy were compared between the groups at baseline and after one year treatment the CPAP adherence and treatment efficacy were recorded. This study was part of our regular testing and quality assurance procedure when developing and revising clinical treatment protocol of sleep apnoea patients. When planning remarkable changes in treatment protocol we have to test whether it is feasible and cost-effective to change the protocol. The data was retrospectively collected from hospital records and nurses' notes (nursing time). According to instructions of our hospital, the Ethics Committee approval is not required. The approval of the hospital (Head of the Division of Medicine) for testing the wireless telemonitoring system of CPAP treatment was applied and received (Protocol Record T200/2013, diary number TO5/049/13). Written informed consent was obtained from those patients allocated to the telemonitoring group.

Official Title
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Telemonitoring in CPAP Treatment

Conditions
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Sleep Apnea

Intervention / Treatment
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* Device: Telemonitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive adult patients commencing CPAP therapy for OSA Exclusion Criteria: Patient not able to co-operate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Experimental: Telemonitoring group<br>Patients allocated to the telemonitoring group started with wireless telemonitoring after the titration period, i.e. in the beginning of habituation phase of CPAP treatment. | Device: Telemonitoring<br>* Wireless telemonitoring<br>* Other names: Restraxx System (ResMed, Sydney, Australia);|
| No Intervention: Usual care group<br>Patients were followed-up during the habituation phase according to hospital's standard procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nursing time | Nursing time includes patient's visit at nurse office, phone calls, check-ups of telemonitoring data and completing patient records | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP adherence measured with in-built clock counter |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea, CPAP, telemonitoring, telecare