OSANCT03051724
Telemedicine for CPAP Therapy Control in OSA
A study testing Telematic follow up in people with OSA, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Obstructive sleep apnea is a very frequent syndrome and Continuous Positive Airway Pressure (CPAP) is the gold standard treatment. Nevertheless, obtaining the sufficient compliance is complex. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- OSA
- What is being tested?
- Telematic follow up
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 6 Feb 2017to 30 Jan 2018
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OSA diagnosis and CPAP prescription
- No use of internet or mobile devices
Who cannot join
- Unstable diseases and severe comorbidities
- Previous CPAP treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telemedicine for CPAP Therapy Control in OSA Patients With Limited Internet Knowledge
Obstructive sleep apnea is a very frequent syndrome and Continuous Positive Airway Pressure (CPAP) is the gold standard treatment. Nevertheless, obtaining the sufficient compliance is complex. New communication technologies and the current health challenges, such as aging and high health care costs have encouraged the interest in new strategies.
As showed recently, telemedicine is an alternative (Isetta, Thorax 2015) in patients that use internet and mobile technologies usually. However, there is a significant percentage of patients that does not use Internet and mobile technologies, only the 58% of patients over 65 years uses them (Dorsey, NEJM 2016). Although evidence regarding telemedicine is conflicting, it suggest that it's applicability depends in patient's characteristics and it is necessary to personalize it to make it safe and effective (Takahashi, Arch Intern Med 2012). That's why the investigators believe that the next step should be to choose those patient's that doesn't use Internet or mobile technologies and to verify the applicability of a telematic system that could facilitate the extra hospital management of this patient's.
The aim of the study is to evaluate the telematic management of various outcomes that are emitted by CPAP machine, and by an app where the patient's will answer different questions regarding their treatment during the three months of study period.
Read the detailed description
We include OSA patient's that are not familiarized with the use of internet and mobile technologies and with CPAP prescription. They follow up an adaptation session where an automatic CPAP machine is delivered. Patient's are titrated with this automatic device in 5-7 days and are treated with the automatic device during 3 months.
The other part of the follow up consists on a voicemail where the patient can contact the sleep unit 24h a day and on a tablet, with an special app where the patient's answer a questionnaire once two weeks.
- Conditions
- OSA
- Being tested
- Telematic follow up
- Keywords
- OSA, CPAP management, Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telematic follow upOther
Follow-up of OSA patients through automatic CPAP with data transmission (Dreamstation; Philips Respironics), a 24-hour voice mailbox available for questions or problems, and an Internet-connected (4G) tablet with a friendly mobile application for simple questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | These OSA patient's are not familiarized with the use of internet and mobile technologies and with CPAP prescription. They follow the intervetion follow up that consists in an adaptation session where the tecnitian delivers them an automatic CPAP machine. Patient's are titrated with this automatic device in 5-7 days and are treated with the automatic device during 3 months.
The other part of the follow up consists on a voicemail where the patient can contact us 24h a day and on an , with an internet-connected tablet with a special app where the patient's answer a questionnaire once two weeks. Receives: Other: Telematic follow up |
| Control group | No intervention | These patient's are patient's that follow the process that all patient's take during CPAP treatment. During the three months of study, the follow up will be the usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the telematic CPAP follow up
CPAP adherence: Hours of use
Measured: 3 months
Secondary outcomes (5)
Efficacy of titration and follow up of data transmitted by CPAP
Leaks, Residual events
Measured: 3 months
Evaluate the effects of treatment in patient's symptomatology
Epworth questionnaire
Measured: 3 months
Evaluate the satisfaction of patient's and professionals
Satisfaction questionnaire
Measured: 3 months
Evaluate the effect of CPAP treatment and telematic follow up
EQ5D questionnaire
Measured: 3 months
To compare the cost of the telematic follow up group vs hospital group
Bayesian cost analysis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start6 Feb 2017
- Primary completion20 Dec 2017
- Study completion30 Jan 2018
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.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose M. Montserrat, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051724
- Sponsor's protocol ID
- PI14/00416_1
- Status last verified
- Feb 2018
- First submitted
- 7 Feb 2017
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine for CPAP Therapy Control in OSA Patients With Limited Internet Knowledge
- ClinicalTrials.gov ID
- NCT03051724
- Acronym / sponsor ID
- PI14/00416_1
- Conditions
- OSA
- Keywords
- OSA, CPAP management, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 14 Feb 2017 (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.
Obstructive sleep apnea is a very frequent syndrome and Continuous Positive Airway Pressure (CPAP) is the gold standard treatment. Nevertheless, obtaining the sufficient compliance is complex. New communication technologies and the current health challenges, such as aging and high health care costs have encouraged the interest in new strategies.
As showed recently, telemedicine is an alternative (Isetta, Thorax 2015) in patients that use internet and mobile technologies usually. However, there is a significant percentage of patients that does not use Internet and mobile technologies, only the 58% of patients over 65 years uses them (Dorsey, NEJM 2016). Although evidence regarding telemedicine is conflicting, it suggest that it's applicability depends in patient's characteristics and it is necessary to personalize it to make it safe and effective (Takahashi, Arch Intern Med 2012). That's why the investigators believe that the next step should be to choose those patient's that doesn't use Internet or mobile technologies and to verify the applicability of a telematic system that could facilitate the extra hospital management of this patient's.
The aim of the study is to evaluate the telematic management of various outcomes that are emitted by CPAP machine, and by an app where the patient's will answer different questions regarding their treatment during the three months of study period.
Detailed description
We include OSA patient's that are not familiarized with the use of internet and mobile technologies and with CPAP prescription. They follow up an adaptation session where an automatic CPAP machine is delivered. Patient's are titrated with this automatic device in 5-7 days and are treated with the automatic device during 3 months.
The other part of the follow up consists on a voicemail where the patient can contact the sleep unit 24h a day and on a tablet, with an special app where the patient's answer a questionnaire once two weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Telematic follow upThese OSA patient's are not familiarized with the use of internet and mobile technologies and with CPAP prescription. They follow the intervetion follow up that consists in an adaptation session where the tecnitian delivers them an automatic CPAP machine. Patient's are titrated with this automatic device in 5-7 days and are treated with the automatic device during 3 months. The other part of the follow up consists on a voicemail where the patient can contact us 24h a day and on an , with an internet-connected tablet with a special app where the patient's answer a questionnaire once two weeks. |
| Control group | No intervention | –These patient's are patient's that follow the process that all patient's take during CPAP treatment. During the three months of study, the follow up will be the usual. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- OSA diagnosis and CPAP prescription
- No use of internet or mobile devices
Key exclusion criteria (2 listed)
- Unstable diseases and severe comorbidities
- Previous CPAP treatment
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 |
|---|---|---|
| Telematic follow upFollow-up of OSA patients through automatic CPAP with data transmission (Dreamstation; Philips Respironics), a 24-hour voice mailbox available for questions or problems, and an Internet-connected (4G) tablet with a friendly mobile application for simple questionnaires. | Other | Intervention group |
Primary outcome
To evaluate the telematic CPAP follow up
Time frame: 3 months
CPAP adherence: Hours of use
5 secondary outcomes
Efficacy of titration and follow up of data transmitted by CPAP
Time frame: 3 months
Evaluate the effects of treatment in patient's symptomatology
Time frame: 3 months
Evaluate the satisfaction of patient's and professionals
Time frame: 3 months
Evaluate the effect of CPAP treatment and telematic follow up
Time frame: 3 months
To compare the cost of the telematic follow up group vs hospital group
Time frame: 3 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 26 Feb 2018.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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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 Telematic follow up in people with OSA, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 2 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 26 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 Spain. 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?
To evaluate the telematic CPAP follow up (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 26 Feb 2018.