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OpenTrials
Completed

NCT Number: NCT01986452

Telemonitoring of CPAP Therapy in Apoplexy Patients With OSA

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.

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Key information

Conditions

OSA Apoplexy Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helios Klinik Hagen

Hagen, North Rhine-Westphalia, 58091, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP therapy

Device

Other names: ICON™

SUPPORT

Other

Other names: Motivation, Telemonitoring, Software Infosmart Web, GSM module

Primary outcomes

  1. Adherence to CPAP usage

    Time frame: 6 months

    CPAP device usage time will be readout and compared.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Institut für Pneumologie Hagen Ambrock eV

Industry

Collaborators

  • Reinhard Löwenstein-Stiftung

Registry information

Official study title

CPAP Therapie Mit Telemonitoring Bei Obstruktiver Schlafapnoe Und Apoplexie

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 18, 2013
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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