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Telemonitoring of CPAP Therapy in Apoplexy Patients With OSA

CPAP Therapie Mit Telemonitoring Bei Obstruktiver Schlafapnoe Und Apoplexie

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01986452
Enrollment
80
Registered
2013-11-18
Start date
2014-02-13
Completion date
2017-10-05
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OSA, Apoplexy

Keywords

OSA, Apoplexy, CPAP, adherence, telemonitoring

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.

Interventions

Sponsors

Reinhard Löwenstein-Stiftung
CollaboratorUNKNOWN
Institut für Pneumologie Hagen Ambrock eV
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adherence to CPAP usage6 monthsCPAP device usage time will be readout and compared.

Secondary

MeasureTime frameDescription
Quality of life6 monthsPatients will fill the questionnaire SF-12 Health Survey before starting the therapy and after 6 months of therapy.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026