Back to resultsTelemonitoring of CPAP Therapy in Apoplexy Patients With OSA
Primary Purpose
OSA, Apoplexy
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CPAP therapy
Support
Sponsored by
About this trial
This is an interventional treatment trial for OSA focused on measuring OSA, Apoplexy, CPAP, adherence, telemonitoring
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
Sites / Locations
- Helios Klinik Hagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Unattended CPAP therapy
Telemonitoring and support
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Adherence to CPAP usage
CPAP device usage time will be readout and compared.
Secondary Outcome Measures
Quality of life
Patients will fill the questionnaire SF-12 Health Survey before starting the therapy and after 6 months of therapy.
Full Information
NCT ID
NCT01986452
First Posted
November 11, 2013
Last Updated
February 20, 2018
Sponsor
Institut für Pneumologie Hagen Ambrock eV
Collaborators
Reinhard Löwenstein-Stiftung
1. Study Identification
Unique Protocol Identification Number
NCT01986452
Brief Title
Telemonitoring of CPAP Therapy in Apoplexy Patients With OSA
Official Title
CPAP Therapie Mit Telemonitoring Bei Obstruktiver Schlafapnoe Und Apoplexie
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 13, 2014 (Actual)
Primary Completion Date
October 5, 2017 (Actual)
Study Completion Date
October 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut für Pneumologie Hagen Ambrock eV
Collaborators
Reinhard Löwenstein-Stiftung
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OSA, Apoplexy
Keywords
OSA, Apoplexy, CPAP, adherence, telemonitoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unattended CPAP therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Telemonitoring and support
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CPAP therapy
Other Intervention Name(s)
ICON™
Intervention Type
Other
Intervention Name(s)
Support
Other Intervention Name(s)
Motivation, Telemonitoring, Software Infosmart Web, GSM module
Primary Outcome Measure Information:
Title
Adherence to CPAP usage
Description
CPAP device usage time will be readout and compared.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
Patients will fill the questionnaire SF-12 Health Survey before starting the therapy and after 6 months of therapy.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Nilius, MD
Organizational Affiliation
Helios Klinik Hagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios Klinik Hagen
City
Hagen
State/Province
NRW
ZIP/Postal Code
58091
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Telemonitoring of CPAP Therapy in Apoplexy Patients With OSA
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