Telemonitoring of CPAP Therapy in Apoplexy Patients With OSA

Study Overview
=================
Brief Summary
-----------------
Apoplexy patients with OSA are often not receiving a CPAP therapy due to generally poor acceptance and adherence. There is a great potential to significantly improve the treatment and care of these patients in a time economic way by telemonitoring the therapy in home environment. This study is planned to prove that telephone consultancy and motivation in times of recorded decreasing CPAP therapy usage can improve adherence, neurological function and quality of life.

Detailed Description
-----------------
Eligible patients with confirmed OSA from neurological rehab department of Helios Clinic Hagen Ambrock are asked to join the study. They will be randomly assigned to one of two arms [CPAP with Telemonitoring (MTM) or without Telemonitoring (OTM)] for 6 months of home treatment after hospital discharge. The MTM arm will receive supporting phone calls when the monitored usage time decreases.

Official Title
-----------------
CPAP Therapie Mit Telemonitoring Bei Obstruktiver Schlafapnoe Und Apoplexie

Conditions
-----------------
OSA, Apoplexy

Intervention / Treatment
-----------------
* Device: CPAP therapy
* Other: Support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: s/p ACM (Arteria Cerebri Media Insult) Diagnosed OSA AHI >15/h Barthel Index item 8 > 5 points (or home assistance) Life expectancy >6 month Capable of giving consent Exclusion Criteria: Already existing ventilatory support (CPAP, NIV etc) Central AI >50% baseline Central AI >5/h under CPAP therapy Drug abuse Pregnant or nursing women Participation in another clinical trial last 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: Unattended CPAP therapy<br>Therapy data will be examined by reading out the CPAP device after 6 months. Patients can obtain help on own request, corresponding to the standard CPAP prescription routine. | Device: CPAP therapy<br> <br> * Other names: ICON™;|
| Experimental: Telemonitoring and support<br>CPAP device therapy data will be downloaded by the study site via GSM modules once a week. In case of poor therapy adherence (defined by a minimum average usage of 3h/night over the week) a contact call will be initiated to motivate patients or solve problems identified by telemonitoring. If active home intervention is required, the study site will inform the healthcare provider to visit the patient in a timely manner. | Device: CPAP therapy<br> <br> * Other names: ICON™;Other: Support<br> <br> * Other names: GSM module;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to CPAP usage | CPAP device usage time will be readout and compared. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Patients will fill the questionnaire SF-12 Health Survey before starting the therapy and after 6 months of therapy. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OSA, Apoplexy, CPAP, adherence, telemonitoring