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Telemedicine for CPAP Therapy Control in OSA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03051724
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Jose M. Montserrat, Hospital Clinic of Barcelona

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.


Condition or disease Intervention/treatment Phase
OSA Other: Telematic follow up Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Telemedicine for CPAP Therapy Control in OSA Patients With Limited Internet Knowledge
Actual Study Start Date : February 6, 2017
Actual Primary Completion Date : December 20, 2017
Actual Study Completion Date : January 30, 2018

Arm Intervention/treatment
Experimental: Intervention group

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.

Other: Telematic 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.

No Intervention: Control group
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.



Primary Outcome Measures :
  1. To evaluate the telematic CPAP follow up [ Time Frame: 3 months ]
    CPAP adherence: Hours of use


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051724


Locations
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Spain
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
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Responsible Party: Jose M. Montserrat, Medical Doctor, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03051724    
Other Study ID Numbers: PI14/00416_1
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose M. Montserrat, Hospital Clinic of Barcelona:
OSA
CPAP management
Telemedicine