Obstructive Sleep ApneaNCT04868422
Telemonitoring of CPAP Therapy in Sleep Apnea Patients
A study testing Telemonitoring via wireless internet-based system in people with Obstructive Sleep Apnea, run by University of Turku at 1 site in Finland.
Trial summary
Wireless telemonitoring is compared with regular nursing procedure in terms of patient satisfaction, adherence to continuous positive pressure (CPAP) treatment and nursing time during the habituation phase of the CPAP therapy in obstructive sleep apnea syndrome (OSAS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Telemonitoring via wireless internet-based system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteFinland
- Study dates
- 14 Aug 2012to 12 Mar 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with diagnosed obstructive sleep apnea
Who cannot join
- Not able to understand Finnish language
- Unable to co-operate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wireless Telemonitoring of Nasal CPAP Therapy in Sleep Apnea Patients
Wireless telemonitoring is compared with regular nursing procedure in terms of patient satisfaction, adherence to continuous positive pressure (CPAP) treatment and nursing time during the habituation phase of the CPAP therapy in obstructive sleep apnea syndrome (OSAS).
Read the detailed description
Both patients and study nurses were unblinded for the wireless telemonitoring system (ResTraxx™Online, ResMed, Sydney, Australia). The module was attached to the S9 Elite™ (ResMed, Sydney, Australia) CPAP device, which transmitted compliance data every day automatically to the ResTraxx™ Online (ResMed, Sydney, Australia) data base. The treatment was considered successful when CPAP use was >4 h/day, mask leak <0.4 L/s, and AHI <5/h during the last 6 days. Study nurses made the data check-ups daily during weekdays and if the criteria for successful CPAP therapy was not achieved during two consecutive nights the nurses adjusted the CPAP pressure remotely and called the patient to give further advice. Patients had also a control viist aftr one year.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Telemonitoring via wireless internet-based system
- Keywords
- sleep apnea, CPAP treatment, telemedicine, nursing time, patient satisfaction
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring via wireless internet-based systemDevice
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring | Experimental | After CPAP titration, patients will be followed with telemonitoring device attached to the fixed pressure CPAP device Receives: Device: Telemonitoring via wireless internet-based system |
| Usual care | No intervention | Patients with fixed pressure CPAP will be followed according to routine protocol without telemonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nursing time
Nursing time of the TM group was estimated as follows: patient education regarding ResTraxx™ Online system (2 min), online data check-ups (0.5 min), remote changes for pressure settings (1 min), telephone guidance (5 min for the end of monitoring, 10 min for each extra call), visit at the study nurse (30- 60 min depending on type of visit), updating the patient records (2 min), and no show visits, which led to organizing a new appointment (20min). The time estimations are based on the measurements of the first 20 telemonitored patients. Nursing time in the UC Group was estimated with the same time calculations as in the TM group presented above with the exception of ttelemonitoring time which was not applicable in the UC group.
Measured: One year after the baseline
Secondary outcomes (1)
Hours of CPAP use
Hours of CPAP use measured by the inbuilt counter of the CPAP device
Measured: One year after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start14 Aug 2012
- Primary completion12 Aug 2014
- Study completion12 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Model description
- The Ethics Committee approval was not required, since this study was part of our quality assurance procedure to revise the treatment protocol.
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital
- Responsible party
- Principal investigator, Tarja Saaresranta, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868422
- Sponsor's protocol ID
- T83/2012
- Other IDs
- K53
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless Telemonitoring of Nasal CPAP Therapy in Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT04868422
- Acronym / sponsor ID
- T83/2012
- Conditions
- Obstructive Sleep Apnea
- Keywords
- sleep apnea, CPAP treatment, telemedicine, nursing time, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Turku University Hospital
- Study start
- 14 Aug 2012 (actual)
- Primary completion
- 12 Aug 2014 (actual)
- Study completion
- 12 Mar 2015 (actual)
- First posted
- 3 May 2021 (actual)
- 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.
Wireless telemonitoring is compared with regular nursing procedure in terms of patient satisfaction, adherence to continuous positive pressure (CPAP) treatment and nursing time during the habituation phase of the CPAP therapy in obstructive sleep apnea syndrome (OSAS).
Detailed description
Both patients and study nurses were unblinded for the wireless telemonitoring system (ResTraxx™Online, ResMed, Sydney, Australia). The module was attached to the S9 Elite™ (ResMed, Sydney, Australia) CPAP device, which transmitted compliance data every day automatically to the ResTraxx™ Online (ResMed, Sydney, Australia) data base. The treatment was considered successful when CPAP use was >4 h/day, mask leak <0.4 L/s, and AHI <5/h during the last 6 days. Study nurses made the data check-ups daily during weekdays and if the criteria for successful CPAP therapy was not achieved during two consecutive nights the nurses adjusted the CPAP pressure remotely and called the patient to give further advice. Patients had also a control viist aftr one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Ethics Committee approval was not required, since this study was part of our quality assurance procedure to revise the treatment protocol.
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | Experimental | Device: Telemonitoring via wireless internet-based systemAfter CPAP titration, patients will be followed with telemonitoring device attached to the fixed pressure CPAP device |
| Usual care | No intervention | –Patients with fixed pressure CPAP will be followed according to routine protocol without telemonitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with diagnosed obstructive sleep apnea
Key exclusion criteria (2 listed)
- Not able to understand Finnish language
- Unable to co-operate
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 |
|---|---|---|
| Telemonitoring via wireless internet-based system | Device | Telemonitoring |
Primary outcome
Nursing time
Time frame: One year after the baseline
Nursing time of the TM group was estimated as follows: patient education regarding ResTraxx™ Online system (2 min), online data check-ups (0.5 min), remote changes for pressure settings (1 min), telephone guidance (5 min for the end of monitoring, 10 min for each extra call), visit at the study nurse (30- 60 min depending on type of visit), updating the patient records (2 min), and no show visits, which led to organizing a new appointment (20min). The time estimations are based on the measurements of the first 20 telemonitored patients. Nursing time in the UC Group was estimated with the same time calculations as in the TM group presented above with the exception of ttelemonitoring time which was not applicable in the UC group.
1 secondary outcome
Hours of CPAP use
Time frame: One year after baseline
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 3 May 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring via wireless internet-based system in people with Obstructive Sleep Apnea, run by University of Turku at 1 site in Finland.
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 1 inclusion and 2 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 3 May 2021. 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 Finland. 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?
Nursing time (time frame: One year after the baseline). 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 3 May 2021.