Telemedicine for CPAP Therapy Control in OSA

OSA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03051724
• Other study ID #: PI14/00416_1
• Status: Completed
• Phase: N/A
• First received: February 7, 2017
• Last updated: February 22, 2018
• Start date: February 6, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: February 2018
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 30, 2018
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• OSA diagnosis and CPAP prescription

• No use of internet or mobile devices

Exclusion Criteria:

• Unstable diseases and severe comorbidities

• Previous CPAP treatment

Related Conditions & MeSH terms

• OSA

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the telematic CPAP follow up	CPAP adherence: Hours of use	3 months
Secondary	Efficacy of titration and follow up of data transmitted by CPAP	Leaks, Residual events	3 months
Secondary	Evaluate the effects of treatment in patient's symptomatology	Epworth questionnaire	3 months
Secondary	Evaluate the satisfaction of patient's and professionals	Satisfaction questionnaire	3 months
Secondary	Evaluate the effect of CPAP treatment and telematic follow up	EQ5D questionnaire	3 months
Secondary	To compare the cost of the telematic follow up group vs hospital group	Bayesian cost analysis	3 months