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

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ClinicalTrials.gov Identifier: NCT03116958
Recruitment Status : Recruiting
First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Collaborator:
Eurecat
Information provided by (Responsible Party):
Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica

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)

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndrome Device: CPAP + Standard care Device: CPAP + Telemedicine Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: MyOSA : Management and Treatment of Patients With Obstructive Sleep Apnea Syndrome(OSAS) Through a Telemedicine System
Study Start Date : November 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: Standard care

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

Experimental: Telemedicine

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




Primary Outcome Measures :
  1. CPAP compliance [ Time Frame: 6 months ]
    Number of hours of use per day of CPAP according to the internal clock of the CPAP device


Secondary Outcome Measures :
  1. CPAP adherence [ Time Frame: 6 months ]
    Numbers of night with more than 4 hours of use

  2. Patients' perceived ease of use of the telemedicine system [ Time Frame: 6 months ]
    Patients in the telemedicine group will be asked to grade the perceived ease of use of the telemedicine platform using a questionnaire

  3. Patients' perceived useful of the telemedicine system [ Time Frame: 6 months ]
    Patients in the telemedicine group will be asked to grade the perceived useful of the telemedicine platform using a questionnaire

  4. Patients' follow-up satisfaction [ Time Frame: 6 months ]
    Patients of both group will be asked to grade their satisfaction with the follow up care provided by the sleep unit using a questionnaire.

  5. Change from baseline in quality of life at 6 months [ Time Frame: at baseline and 6 months ]
    EuroQOL health questionnaire will be used.

  6. Change from baseline in daytime sleepiness at 6 months [ Time Frame: at baseline and 6 months ]
    Epworth sleepiness scale will be used.

  7. Abandons at 6 months [ Time Frame: 6 months ]
    Number of patients lost at follow up at 6 months of CPAP therapy.

  8. Cost effectiveness at 6 months [ Time Frame: 6 months ]
    Costs in each group (telemedicine cost, CPAP carrying charge, number of visits and calls) will be compared.

  9. Changes in treatment side effects [ Time Frame: 6 months ]
  10. Change in blood pressure at 6 months [ Time Frame: at baseline and 6 months ]
  11. Change in body mass index (in kg/m^2) at 6 months [ Time Frame: at baseline and 6 months ]
  12. Change from baseline in Visual analogue scale for quality of life at 6 months [ Time Frame: at baseline and 6 months ]
    Visual analogue scale for quality of life will be used

  13. Change in weight (in kg) at 6 months [ Time Frame: at baseline and 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT03116958


Contacts
Contact: Ferran Barbe, MD 0034973705372 fbarbe.lleida.ics@gencat.cat

Locations
Spain
Hospital Arnau de Vilanova Recruiting
Lleida, Spain, 25198
Contact: Ferran Barbe, MD    34973705372    febarbe.lleida.ics@gencat.cat   
Principal Investigator: Ferran Barbe, MD         
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Eurecat
Investigators
Principal Investigator: Ferran Barbe, MD Hospital Arnau de Vilanova. IRB Lleida. CIBERes

Responsible Party: Ferran Barbe, Head of Respiratory department at Hospital Universitari Arnau de Vilanova, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier: NCT03116958     History of Changes
Other Study ID Numbers: SEPAR 2016
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica:
CPAP compliance
Telemedicine integrated platform
Standard management
Cost-effectiveness

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Apnea
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases