Clinical trial NCT03051724: Telemedicine for CPAP Therapy Control in OSA
Official title: Telemedicine for CPAP Therapy Control in OSA Patients With Limited Internet Knowledge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OSA
Keywords: OSA
CPAP management
Telemedicine
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Unstable diseases and severe comorbidities
* Previous CPAP treatment

Primary outcomes:
measure: To evaluate the telematic CPAP follow up
timeFrame: 3 months
Secondary outcomes:
measure: Efficacy of titration and follow up of data transmitted by CPAP
timeFrame: 3 months
measure: Evaluate the effects of treatment in patient's symptomatology
timeFrame: 3 months
measure: Evaluate the satisfaction of patient's and professionals
timeFrame: 3 months
measure: Evaluate the effect of CPAP treatment and telematic follow up
timeFrame: 3 months
measure: To compare the cost of the telematic follow up group vs hospital group
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References: