MyOSA : Management and Treatment of Patients With Obstructive Sleep Apnea Syndrome(OSAS) Through a Telemedicine System

NCT03116958 | Completed

• 1 other identifier: SEPAR 2016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to improve CPAP treatment compliance of Obstructive Sleep Apnea Syndrome using an integrated telemedicine platform (MyOSA system)

Conditions

Sleep Apnea Syndrome

Keywords

CPAP compliance; Telemedicine integrated platform; Standard management; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• CPAP compliance

  Number of hours of use per day of CPAP according to the internal clock of the CPAP device

  6 months

Secondary Outcomes (13)

• CPAP adherence

  6 months

• Patients' perceived ease of use of the telemedicine system

  6 months

• Patients' perceived useful of the telemedicine system

  6 months

• Patients' follow-up satisfaction

  6 months

• Change from baseline in quality of life at 6 months

  at baseline and 6 months

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Patients diagnosed as OSA, treated with CPAP and followed up in sleep unit as per usual care. Patients will be fitted with a mask and given a CPAP and instructed on how to use the device. Each CPAP machine will be provided with a modem sending daily compliance and adherence information to MyOSA web site but no intervention based on these data is planned in this group. All patients will be visited at 1,3 and 6 months at sleep unit. Patients will be checked about progress and adherence to therapy and any problems with their machine. Information will be downloaded from their machines (CPAP adherence, applied CPAP pressure, mask leak, and residual respiratory events…).

Device: CPAP + Standard care

Telemedicine

EXPERIMENTAL

Patients diagnosed as OSA and treated with CPAP, followed up in sleep unit, adding a telemedicine integrated system. Patients will be fitted with a mask , given a CPAP, and instructed on how to use the device. Using patients' baseline and initial follow-up data a software will provide a prediction of CPAP compliance at 6 months, and propose personalized interventions to increase compliance (smartphone app). All patients will be visited at 3 and 6 months at sleep unit. Patients will be checked about progress and adherence to therapy and any problems with their machine.

Device: CPAP + Telemedicine

Interventions

CPAP + Standard care DEVICE

CPAP device + Standard management at Sleep Unit. According to Spanish Respiratory Society guidelines during 6 months

Standard care

CPAP + Telemedicine DEVICE

CPAP+ telemedicine approach. Patients followed up at Sleep Unit according to Spanish Respiratory Society guidelines during 6 months.

Telemedicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and Women over 18 years old
• Diagnosed as OSA and requiring CPAP treatment
• Good knowledge of the use of a smartphone
• Written informed consent form signed

You may not qualify if:

• Patients with impaired lung function (overlap syndrome, obesity hypoventilation syndrome, and restrictive disorders)
• Severe heart failure
• Severe chronic pathology associated
• Psychiatric disorder
• Periodic leg movements
• Pregnancy
• Other dyssomnias or parasomnias
• Patients already treated with CPAP

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead
• Fundació Eurecat: collaborator

Study Sites (1)

Hospital Arnau de Vilanova

Lleida, 25198, Spain

Location

Related Publications (2)

• Turino C, Benitez ID, Rafael-Palou X, Mayoral A, Lopera A, Pascual L, Vaca R, Cortijo A, Moncusi-Moix A, Dalmases M, Vargiu E, Blanco J, Barbe F, de Batlle J. Management and Treatment of Patients With Obstructive Sleep Apnea Using an Intelligent Monitoring System Based on Machine Learning Aiming to Improve Continuous Positive Airway Pressure Treatment Compliance: Randomized Controlled Trial. J Med Internet Res. 2021 Oct 18;23(10):e24072. doi: 10.2196/24072.

  PMID: 34661550 DERIVED

• Rafael-Palou X, Turino C, Steblin A, Sanchez-de-la-Torre M, Barbe F, Vargiu E. Comparative analysis of predictive methods for early assessment of compliance with continuous positive airway pressure therapy. BMC Med Inform Decis Mak. 2018 Sep 18;18(1):81. doi: 10.1186/s12911-018-0657-z.

  PMID: 30227856 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ferran Barbe, MD

  Hospital Arnau de Vilanova. IRB Lleida. CIBERes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Respiratory department at Hospital Universitari Arnau de Vilanova

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 17, 2017
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)