OSANCT01986452
Telemonitoring of CPAP Therapy in Apoplexy Patients With OSA
A study testing CPAP therapy and Support in people with OSA and Apoplexy, run by Institut für Pneumologie Hagen Ambrock eV at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- CPAP therapy and Support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 13 Feb 2014to 5 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CPAP Therapie Mit Telemonitoring Bei Obstruktiver Schlafapnoe Und Apoplexie
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.
Read the 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.
- Being tested
- CPAP therapy, Support
- Keywords
- OSA, Apoplexy, CPAP, adherence, telemonitoring
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP therapyDevice
Also called ICON™
SupportOther
Also called Motivation, Telemonitoring, Software Infosmart Web, GSM module
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: CPAP therapy; Other: Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to CPAP usage
CPAP device usage time will be readout and compared.
Measured: 6 months
Secondary outcomes (1)
Quality of life
Patients will fill the questionnaire SF-12 Health Survey before starting the therapy and after 6 months of therapy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study start13 Feb 2014
- Primary completion5 Oct 2017
- Study completion5 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Reinhard Löwenstein-Stiftung
- Responsible party
- Principal investigator, Georg Nilius, Institut für Pneumologie Hagen Ambrock eV
- Investigators
- Georg Nilius, MD, Principal investigator, Helios Klinik Hagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986452
- Sponsor's protocol ID
- StrOSA2013
- Status last verified
- Feb 2018
- First submitted
- 11 Nov 2013
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPAP Therapie Mit Telemonitoring Bei Obstruktiver Schlafapnoe Und Apoplexie
- ClinicalTrials.gov ID
- NCT01986452
- Acronym / sponsor ID
- StrOSA2013
- Keywords
- OSA, Apoplexy, CPAP, adherence, telemonitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eVIndustry (pharma, biotech, devices)
- Collaborators
- Reinhard Löwenstein-Stiftung
- Study start
- 13 Feb 2014 (actual)
- Primary completion
- 5 Oct 2017 (actual)
- Study completion
- 5 Oct 2017 (actual)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unattended CPAP therapy | Active comparator | Device: CPAP therapyTherapy 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. |
| Telemonitoring and support | Experimental | Device: CPAP therapy, Other: SupportCPAP 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Already existing ventilatory support (CPAP, NIV etc)
- Central AI >50% baseline
- Central AI >5/h under CPAP therapy
- Drug abuse
- Pregnant or nursing women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP therapyAlso: ICON™ | Device | Telemonitoring and support, Unattended CPAP therapy |
| SupportAlso: Motivation, Telemonitoring, Software Infosmart Web, GSM module | Other | Telemonitoring and support |
Primary outcome
Adherence to CPAP usage
Time frame: 6 months
CPAP device usage time will be readout and compared.
1 secondary outcome
Quality of life
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Nilius, MD principal investigator
Helios Klinik Hagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP therapy and Support in people with OSA and Apoplexy, run by Institut für Pneumologie Hagen Ambrock eV at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to CPAP usage (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.