Telemonitoring of CPAP Therapy in Apoplexy Patients With OSA

Institut für Pneumologie Hagen Ambrock eV

Status: Completed

Conditions: Apoplexy; OSA

Treatments: Other: Support; Device: CPAP therapy

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01986452

StrOSA2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Unattended CPAP therapy

Active Comparator group

Description:

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.

Treatment:

Device: CPAP therapy

Telemonitoring and support

Experimental group

Description:

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.

Treatment:

Device: CPAP therapy

Other: Support