Telemedicine for CPAP Therapy Control in OSA

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

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.

Study Overview

• Status: Completed
• Conditions: OSA
• Intervention / Treatment: Other: Telematic follow up

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Unstable diseases and severe comorbidities
• Previous CPAP treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the telematic CPAP follow up	CPAP adherence: Hours of use	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of titration and follow up of data transmitted by CPAP	Leaks, Residual events	3 months
Evaluate the effects of treatment in patient's symptomatology	Epworth questionnaire	3 months
Evaluate the satisfaction of patient's and professionals	Satisfaction questionnaire	3 months
Evaluate the effect of CPAP treatment and telematic follow up	EQ5D questionnaire	3 months
To compare the cost of the telematic follow up group vs hospital group	Bayesian cost analysis	3 months

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 6, 2017
• Primary Completion (ACTUAL): December 20, 2017
• Study Completion (ACTUAL): January 30, 2018

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (ACTUAL): February 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Telemedicine; OSA; CPAP management
• Other Study ID Numbers: PI14/00416_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No