Apnea, ObstructiveNCT04297163
Telemonitoring for the Recuperation of Patients With CPAP
A study testing Telemedicine and In Hospital in people with Apnea, Obstructive, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
This study is aimed at patients who do not achieve a minimum (≥4 hours/night) or optimal (≥5,5 hours/night) use of Continuous Positive Airway Pressure (CPAP) treatment and it is proposed to improve their adherence making a 4-weeks intervention using telemedicine tools: CPAP remote monitoring, a mobile application… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apnea, Obstructive
- What is being tested?
- Telemedicine and In Hospital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2019to 20 May 2021
- 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
- Age ≥ 18 years,
- CPAP treatment initiated ≥1 month and <12 months
- CPAP compliance below 5.5 hours per night,
- Regular use of Smartphone and mobile apps.
Who cannot join
- Clinical suspicion or other confirmed sleep pathology,
- Severe nasal obstruction that prevents the use of CPAP,
- Physical-psychological inability to follow questionnaires and the program,
- Patients undergoing uvulopalatopharyngoplasty,
- Cheyne-Stokes syndrome,
- Pregnancy,
- Rejection in the initial test with CPAP during the training and education session and
- Failure to obtain informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Josep M Montserrat Canal
Barcelona, Catalonia, 08036
Monique C Suarez Giron, MD PhD, 932275746 ext. 5746, mcsuarez@clinic.cat
Onintza Garmendia, MsC, 932275746 ext. 5746, garmendia@clinic.cat
About this study
This study is aimed at patients who do not achieve a minimum (≥4 hours/night) or optimal (≥5,5 hours/night) use of Continuous Positive Airway Pressure (CPAP) treatment and it is proposed to improve their adherence making a 4-weeks intervention using telemedicine tools: CPAP remote monitoring, a mobile application (app) and a voicemail. The concept of this work is to "recover" patients to minimum or optimal CPAP use.
Read the detailed description
Given the prevalence of Obstructive Sleep Apnea (OSA), the symptoms it produces, which is a risk factor for various entities and that, in addition, its treatment clearly improves others; its control must be optimized in an effective and cost-effective manner. The use of information and communication technologies (ICT) in this context can be very beneficial.
The design of the study is prospective, randomized, controlled, open and parallel.
A ICT-based out of hospital management of OSA is implemented to be compared with the classical in-hospital management.
The main objectives were to evaluate the effectiveness of of two OSA management programs: the in-hospital classic management versus a telemedicine program based on the use of ICTs in the recovery of patients with OSA who who do not meet the minimum treatment (4 hours) or in those who do not comply with the optimal use (5.5 hours).
This is a 4-weeks management randomized, with parallel groups study. Participants will be patients from the Sleep Unit of Hospital Clinic Barcelona with OSA diagnosis and CPAP treatment indication, who after a follow-up between 3-months and up to 5 years have a CPAP compliance below 5,5 hours/night.
Two management programs will be compared:
- In-hospital classic management: Patients are followed regularly in the hospital with a face-to-face visit by the Sleep unit nurse.
- Telemedicine management: telemedicine support with mobile app, voicemail and CPAP remote monitoring.
- Conditions
- Apnea, Obstructive
- Being tested
- Telemedicine, In Hospital
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Remote CPAP monitoring, mobile app and voice mail
In HospitalOther
Face-to-face follow up
| Study group | Role | What they receive |
|---|---|---|
| Hospital management | Active comparator | Patient's receive no intervention, the follow up is the usual for a patient following CPAP therapy. Receives: Other: In Hospital |
| Telemedicine management | Experimental | CPAP remote monitoring of patients, including a mobile application and a voicemail. Receives: Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP use
Compliance to CPAP treatment (Number of hours that the patient uses CPAP) will be taken as the main variable.
Measured: 4-weeks
Secondary outcomes (3)
Quality of life assessment
Functional Outcomes Sleep Questionnaire (FOSQ) and EuroQol-5D (EQ-5D)
Measured: 4-weeks
Sleepiness assessment
Epworth sleepiness scale (ESS)
Measured: 4 weeks
Satisfaction assessment
Satisfaction questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Nov 2019
- Primary completion1 Apr 2021 (estimated)
- Study completion20 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea, ObstructiveStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4-weeks randomized with parallel groups study.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Jose M. Montserrat, Hospital Clinic of Barcelona
- Investigators
- Josep M Montserrat, Prof, Study director, Hospital Clinic/Universitat de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297163
- Sponsor's protocol ID
- PI17/01068
- Status last verified
- Mar 2021
- First submitted
- 27 Feb 2020
- Last updated
- 19 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemonitoring for the Recuperation of Patients With CPAP
- ClinicalTrials.gov ID
- NCT04297163
- Acronym / sponsor ID
- PI17/01068
- Conditions
- Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 20 May 2021 (estimated)
- First posted
- 5 Mar 2020 (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.
This study is aimed at patients who do not achieve a minimum (≥4 hours/night) or optimal (≥5,5 hours/night) use of Continuous Positive Airway Pressure (CPAP) treatment and it is proposed to improve their adherence making a 4-weeks intervention using telemedicine tools: CPAP remote monitoring, a mobile application (app) and a voicemail. The concept of this work is to "recover" patients to minimum or optimal CPAP use.
Detailed description
Given the prevalence of Obstructive Sleep Apnea (OSA), the symptoms it produces, which is a risk factor for various entities and that, in addition, its treatment clearly improves others; its control must be optimized in an effective and cost-effective manner. The use of information and communication technologies (ICT) in this context can be very beneficial.
The design of the study is prospective, randomized, controlled, open and parallel.
A ICT-based out of hospital management of OSA is implemented to be compared with the classical in-hospital management.
The main objectives were to evaluate the effectiveness of of two OSA management programs: the in-hospital classic management versus a telemedicine program based on the use of ICTs in the recovery of patients with OSA who who do not meet the minimum treatment (4 hours) or in those who do not comply with the optimal use (5.5 hours).
This is a 4-weeks management randomized, with parallel groups study. Participants will be patients from the Sleep Unit of Hospital Clinic Barcelona with OSA diagnosis and CPAP treatment indication, who after a follow-up between 3-months and up to 5 years have a CPAP compliance below 5,5 hours/night.
Two management programs will be compared:
- In-hospital classic management: Patients are followed regularly in the hospital with a face-to-face visit by the Sleep unit nurse.
- Telemedicine management: telemedicine support with mobile app, voicemail and CPAP remote monitoring.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 4-weeks randomized with parallel groups study.
| Arm | Type | Receives |
|---|---|---|
| Hospital management | Active comparator | Other: In HospitalPatient's receive no intervention, the follow up is the usual for a patient following CPAP therapy. |
| Telemedicine management | Experimental | Other: TelemedicineCPAP remote monitoring of patients, including a mobile application and a voicemail. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years,
- CPAP treatment initiated ≥1 month and <12 months
- CPAP compliance below 5.5 hours per night,
- Regular use of Smartphone and mobile apps.
Key exclusion criteria (8 listed)
- Clinical suspicion or other confirmed sleep pathology,
- Severe nasal obstruction that prevents the use of CPAP,
- Physical-psychological inability to follow questionnaires and the program,
- Patients undergoing uvulopalatopharyngoplasty,
- Cheyne-Stokes syndrome,
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 |
|---|---|---|
| TelemedicineRemote CPAP monitoring, mobile app and voice mail | Other | Telemedicine management |
| In HospitalFace-to-face follow up | Other | Hospital management |
Primary outcome
CPAP use
Time frame: 4-weeks
Compliance to CPAP treatment (Number of hours that the patient uses CPAP) will be taken as the main variable.
3 secondary outcomes
Quality of life assessment
Time frame: 4-weeks
Sleepiness assessment
Time frame: 4 weeks
Satisfaction assessment
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
Josep M Montserrat, Prof study director
Hospital Clinic/Universitat de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine and In Hospital in people with Apnea, Obstructive, 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josep M Montserrat, Prof (932275746, jmmontserrat@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP use (time frame: 4-weeks). 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 19 Mar 2021.