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Telemedicine for CPAP Therapy Control in OSA

Telemedicine for CPAP Therapy Control in OSA Patients With Limited Internet Knowledge

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03051724
Enrollment
30
Registered
2017-02-14
Start date
2017-02-06
Completion date
2018-01-30
Last updated
2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OSA

Keywords

OSA, CPAP management, Telemedicine

Brief 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. 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.

Interventions

OTHERTelematic follow up

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.

Sponsors

Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* OSA diagnosis and CPAP prescription * No use of internet or mobile devices

Exclusion criteria

* Unstable diseases and severe comorbidities * Previous CPAP treatment

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the telematic CPAP follow up3 monthsCPAP adherence: Hours of use

Secondary

MeasureTime frameDescription
Efficacy of titration and follow up of data transmitted by CPAP3 monthsLeaks, Residual events
Evaluate the effects of treatment in patient's symptomatology3 monthsEpworth questionnaire
Evaluate the satisfaction of patient's and professionals3 monthsSatisfaction questionnaire
Evaluate the effect of CPAP treatment and telematic follow up3 monthsEQ5D questionnaire
To compare the cost of the telematic follow up group vs hospital group3 monthsBayesian cost analysis

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026