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Telemonitoring of CPAP Therapy in Apoplexy Patients With OSA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986452
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : February 22, 2018
Sponsor:
Collaborator:
Reinhard Löwenstein-Stiftung
Information provided by (Responsible Party):
Georg Nilius, Institut für Pneumologie Hagen Ambrock eV

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
OSA Apoplexy Device: CPAP therapy Other: Support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : February 13, 2014
Actual Primary Completion Date : October 5, 2017
Actual Study Completion Date : October 5, 2017

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 Name: 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 Name: ICON™

Other: Support
Other Names:
  • Motivation
  • Telemonitoring
  • Software Infosmart Web
  • GSM module




Primary Outcome Measures :
  1. Adherence to CPAP usage [ Time Frame: 6 months ]
    CPAP device usage time will be readout and compared.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986452


Locations
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Germany
Helios Klinik Hagen
Hagen, NRW, Germany, 58091
Sponsors and Collaborators
Institut für Pneumologie Hagen Ambrock eV
Reinhard Löwenstein-Stiftung
Investigators
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Principal Investigator: Georg Nilius, MD Helios Klinik Hagen
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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: November 18, 2013    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Keywords provided by Georg Nilius, Institut für Pneumologie Hagen Ambrock eV:
OSA
Apoplexy
CPAP
adherence
telemonitoring
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases