Sleep ApneaTeleCPAPNCT02509247
Telemonitoring in CPAP Treatment
A study testing Telemonitoring in people with Sleep Apnea, run by Turku University Hospital at 1 site in Finland.
Trial summary
Wireless telemonitoring was used during the habituation phase of continuous positive airway pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated either to the telemonitoring group (n=50) or the usual care group (n=61). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Telemonitoring
- 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
- Aug 2012to 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive adult patients commencing CPAP therapy for OSA
Who cannot join
- Patient not able to co-operate
Trial locations and contacts
1 site in 1 country.
About this study
Wireless telemonitoring was used during the habituation phase of continuous positive airway pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing time, patient satisfaction and treatment efficiency and efficacy were compared between the groups at baseline and after one year treatment the CPAP adherence and treatment efficacy were recorded.
Read the detailed description
Wireless telemonitoring was used during the habituation phase of continuous positive airway pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing time, patient satisfaction and treatment efficiency and efficacy were compared between the groups at baseline and after one year treatment the CPAP adherence and treatment efficacy were recorded.
This study was part of our regular testing and quality assurance procedure when developing and revising clinical treatment protocol of sleep apnoea patients. When planning remarkable changes in treatment protocol we have to test whether it is feasible and cost-effective to change the protocol. The data was retrospectively collected from hospital records and nurses' notes (nursing time). According to instructions of our hospital, the Ethics Committee approval is not required. The approval of the hospital (Head of the Division of Medicine) for testing the wireless telemonitoring system of CPAP treatment was applied and received (Protocol Record T200/2013, diary number TO5/049/13). Written informed consent was obtained from those patients allocated to the telemonitoring group.
- Conditions
- Sleep Apnea
- Being tested
- Telemonitoring
- Keywords
- sleep apnea, CPAP, telemonitoring, telecare
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringDevice
Also called Restraxx System (ResMed, Sydney, Australia)
Wireless telemonitoring
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring group | Experimental | Patients allocated to the telemonitoring group started with wireless telemonitoring after the titration period, i.e. in the beginning of habituation phase of CPAP treatment. Receives: Device: Telemonitoring |
| Usual care group | No intervention | Patients were followed-up during the habituation phase according to hospital's standard procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nursing time
Nursing time includes patient's visit at nurse office, phone calls, check-ups of telemonitoring data and completing patient records
Measured: 3 months
Secondary outcomes (1)
CPAP adherence measured with in-built clock counter
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startAug 2012
- Primary completionAug 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tarja Saaresranta, MD, Phd, Principal investigator, Hospital District of Southwest Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509247
- Sponsor's protocol ID
- T200/2013
- Acronym
- TeleCPAP
- Status last verified
- Jul 2015
- First submitted
- 10 Jun 2015
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemonitoring in CPAP Treatment
- ClinicalTrials.gov ID
- NCT02509247
- Acronym / sponsor ID
- TeleCPAP / T200/2013
- Conditions
- Sleep Apnea
- Keywords
- sleep apnea, CPAP, telemonitoring, telecare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Jul 2015 (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.
Wireless telemonitoring was used during the habituation phase of continuous positive airway pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing time, patient satisfaction and treatment efficiency and efficacy were compared between the groups at baseline and after one year treatment the CPAP adherence and treatment efficacy were recorded.
Detailed description
Wireless telemonitoring was used during the habituation phase of continuous positive airway pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing time, patient satisfaction and treatment efficiency and efficacy were compared between the groups at baseline and after one year treatment the CPAP adherence and treatment efficacy were recorded.
This study was part of our regular testing and quality assurance procedure when developing and revising clinical treatment protocol of sleep apnoea patients. When planning remarkable changes in treatment protocol we have to test whether it is feasible and cost-effective to change the protocol. The data was retrospectively collected from hospital records and nurses' notes (nursing time). According to instructions of our hospital, the Ethics Committee approval is not required. The approval of the hospital (Head of the Division of Medicine) for testing the wireless telemonitoring system of CPAP treatment was applied and received (Protocol Record T200/2013, diary number TO5/049/13). Written informed consent was obtained from those patients allocated to the telemonitoring group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring group | Experimental | Device: TelemonitoringPatients allocated to the telemonitoring group started with wireless telemonitoring after the titration period, i.e. in the beginning of habituation phase of CPAP treatment. |
| Usual care group | No intervention | –Patients were followed-up during the habituation phase according to hospital's standard procedure. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive adult patients commencing CPAP therapy for OSA
Key exclusion criteria (1 listed)
- Patient not able 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 |
|---|---|---|
| TelemonitoringAlso: Restraxx System (ResMed, Sydney, Australia)Wireless telemonitoring | Device | Telemonitoring group |
Primary outcome
Nursing time
Time frame: 3 months
Nursing time includes patient's visit at nurse office, phone calls, check-ups of telemonitoring data and completing patient records
1 secondary outcome
CPAP adherence measured with in-built clock counter
Time frame: 1 year
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 27 Jul 2015.
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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.
Tarja Saaresranta, MD, Phd principal investigator
Hospital District of Southwest Finland
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 in people with Sleep Apnea, run by Turku University Hospital 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 1 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 27 Jul 2015. 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: 3 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 27 Jul 2015.