Telemonitoring of CPAP Therapy in Apoplexy Patients With OSA

February 20, 2018 updated by: Georg Nilius, Institut für Pneumologie Hagen Ambrock eV

CPAP Therapie Mit Telemonitoring Bei Obstruktiver Schlafapnoe Und Apoplexie

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Hagen, NRW, Germany, 58091
        • Helios Klinik Hagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: CPAP therapy
Other Names:
  • ICON™
Experimental: 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.
Device: CPAP therapy
Other Names:
  • ICON™
Other: Support
Other Names:
  • Motivation
  • Telemonitoring
  • Software Infosmart Web
  • GSM module

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut für Pneumologie Hagen Ambrock eV

Collaborators

Reinhard Löwenstein-Stiftung

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2014

Primary Completion (Actual)

October 5, 2017

Study Completion (Actual)

October 5, 2017

Study Registration Dates

First Submitted

November 11, 2013

First Submitted That Met QC Criteria

November 11, 2013

First Posted (Estimate)

November 18, 2013

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StrOSA2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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