Clincosm LogoSign in Get a demo

Telemonitoring of CPAP Therapy in Apoplexy Patients With OSA

Sponsor
Institut für Pneumologie Hagen Ambrock eV (Industry)
Overall Status
Completed
CT.gov ID
NCT01986452
Collaborator
Reinhard Löwenstein-Stiftung (Other)
80
Enrollment
1
Location
2
Arms
43.7
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CPAP therapy
  • Other: Support
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CPAP Therapie Mit Telemonitoring Bei Obstruktiver Schlafapnoe Und Apoplexie
Actual Study Start Date :
Feb 13, 2014
Actual Primary Completion Date :
Oct 5, 2017
Actual Study Completion Date :
Oct 5, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adherence to CPAP usage [6 months]

      CPAP device usage time will be readout and compared.

    Secondary Outcome Measures

    1. Quality of life [6 months]

      Patients will fill the questionnaire SF-12 Health Survey before starting the therapy and after 6 months of therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Helios Klinik Hagen Hagen NRW Germany 58091

    Sponsors and Collaborators

    • Institut für Pneumologie Hagen Ambrock eV
    • Reinhard Löwenstein-Stiftung

    Investigators

    • Principal Investigator: Georg Nilius, MD, Helios Klinik Hagen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Georg Nilius, Head of Pneumology Department of Helios Clinic Hagen, Institut für Pneumologie Hagen Ambrock eV
    ClinicalTrials.gov Identifier:
    NCT01986452
    Other Study ID Numbers:
    • StrOSA2013
    First Posted:
    Nov 18, 2013
    Last Update Posted:
    Feb 22, 2018
    Last Verified:
    Feb 1, 2018
    Keywords provided by Georg Nilius, Head of Pneumology Department of Helios Clinic Hagen, Institut für Pneumologie Hagen Ambrock eV
    OSA
    Apoplexy
    CPAP
    adherence
    telemonitoring
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of Feb 22, 2018