Telemonitoring of CPAP Therapy in Apoplexy Patients With OSA

NCT ID: NCT01986452

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-13
• Study Completion Date: 2017-10-05

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.

Conditions

OSA; Apoplexy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unattended CPAP therapy

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.

Group Type: ACTIVE_COMPARATOR

CPAP therapy

Intervention Type: DEVICE

Telemonitoring and support

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.

Group Type: EXPERIMENTAL

CPAP therapy

Intervention Type: DEVICE

Support

Intervention Type: OTHER

Interventions

CPAP therapy

Intervention Type: DEVICE

Support

Intervention Type: OTHER

Other Intervention Names

ICON™; Motivation; Telemonitoring; Software Infosmart Web; GSM module

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reinhard Löwenstein-Stiftung

UNKNOWN

Sponsor Role: collaborator

Institut für Pneumologie Hagen Ambrock eV

INDUSTRY

Sponsor Role: lead

Responsible Party

Georg Nilius

Head of Pneumology Department of Helios Clinic Hagen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georg Nilius, MD

Role: PRINCIPAL_INVESTIGATOR

Helios Klinik Hagen

Locations

Helios Klinik Hagen

Hagen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

StrOSA2013

Identifier Type: -

Identifier Source: org_study_id