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OpenTrials
Completed

NCT Number: NCT03051724

Telemedicine for CPAP Therapy Control in OSA

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.

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Key information

Conditions

OSA

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unstable diseases and severe comorbidities
  • Previous CPAP treatment

Treatment and study plan

Telematic follow up

Other

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.

Primary outcomes

  1. To evaluate the telematic CPAP follow up

    Time frame: 3 months

    CPAP adherence: Hours of use

Secondary outcomes

  1. Efficacy of titration and follow up of data transmitted by CPAP

    Time frame: 3 months

    Leaks, Residual events

  2. Evaluate the effects of treatment in patient's symptomatology

    Time frame: 3 months

    Epworth questionnaire

  3. Evaluate the satisfaction of patient's and professionals

    Time frame: 3 months

    Satisfaction questionnaire

  4. Evaluate the effect of CPAP treatment and telematic follow up

    Time frame: 3 months

    EQ5D questionnaire

  5. To compare the cost of the telematic follow up group vs hospital group

    Time frame: 3 months

    Bayesian cost analysis

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Feb 14, 2017
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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