Telemonitoring of CPAP Therapy in Apoplexy Patients With OSA

NCT01986452 | Completed

• 1 other identifier: StrOSA2013
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

OSA; Apoplexy

Keywords

OSA; Apoplexy; CPAP; adherence; telemonitoring

Outcome Measures

Primary Outcomes (1)

• Adherence to CPAP usage

  CPAP device usage time will be readout and compared.

  6 months

Secondary Outcomes (1)

• Quality of life

  6 months

Study Arms (2)

Unattended CPAP therapy

ACTIVE COMPARATOR

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

Telemonitoring and support

EXPERIMENTAL

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: Support

Interventions

CPAP therapy DEVICE

Also known as: ICON™

Telemonitoring and support; Unattended CPAP therapy

Support OTHER

Also known as: Motivation, Telemonitoring, Software Infosmart Web, GSM module

Telemonitoring and support

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut für Pneumologie Hagen Ambrock eV: lead
• Reinhard Löwenstein-Stiftung: collaborator

Study Sites (1)

Helios Klinik Hagen

Hagen, North Rhine-Westphalia, 58091, Germany

Location

MeSH Terms

Conditions

Stroke

Interventions

Palliative Care; Information Motivation Behavioral Skills Model

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Models, Psychological; Models, Theoretical; Investigative Techniques

Study Officials

• Georg Nilius, MD

  Helios Klinik Hagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pneumology Department of Helios Clinic Hagen

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 18, 2013
• Study Start: February 13, 2014
• Primary Completion: October 5, 2017
• Study Completion: October 5, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

DE (1)