Telemonitoring of CPAP Therapy in Apoplexy Patients With OSA

OSA Clinical Trial

Official title:

CPAP Therapie Mit Telemonitoring Bei Obstruktiver Schlafapnoe Und Apoplexie

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986452
• Other study ID #: StrOSA2013
• Status: Completed
• Phase: N/A
• First received: November 11, 2013
• Last updated: February 20, 2018
• Start date: February 13, 2014
• Est. completion date: October 5, 2017

Study information

• Verified date: February 2018
• Source: Institut für Pneumologie Hagen Ambrock eV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 5, 2017
• Est. primary completion date: October 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Apoplexy
• OSA
• Stroke

Intervention

Device:
• CPAP therapy

Other:
• Support

Locations

Country	Name	City	State
Germany	Helios Klinik Hagen	Hagen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pneumologie Hagen Ambrock eV	Reinhard Löwenstein-Stiftung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to CPAP usage	CPAP device usage time will be readout and compared.	6 months
Secondary	Quality of life	Patients will fill the questionnaire SF-12 Health Survey before starting the therapy and after 6 months of therapy.	6 months