Compliance With Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Syndrome

NCT ID: NCT03776084

Last Updated: 2021-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

405 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-09-01

Brief Summary

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The aim of the study is to know the adherence to treatment and compliance of patients diagnosed with SAHS and with indication of CPAP from the sleep unit of the Hospital de Sabadell.

Detailed Description

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The investigatror's objective will be to know the adherence to treatment and compliance of patients diagnosed with SAHS and with indication of CPAP of the sleep unit of the Hospital de Sabadell. Is a cohort study. The dependent variables are adherence to treatment (% patients who continue using CPAP one year after initiation of treatment) and objective compliance with treatment (defined as use of ≥4h / night). For a confidence level of 95%, a sample of 405 patients was recruited, recruited consecutively at a rate of 33 patients per month among those diagnosed with SAHS and those indicated with CPAP treatment. This number foresees a possible abandonment rate of 5%. For the statistical analysis of the data related to compliance with the therapy and compliance with the follow-up process, descriptive analysis of the data with means, median and 95% CI, or percentages with 95% CI. For the statistical analysis of the factors influencing compliance: multivariate logistic regression.

Conditions

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Sleep Apnea, Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients SAHS with CPAP

Continuous Positive Airway Pressure treatment

Continuous Positive Airway Pressure

Intervention Type DEVICE

CPAP indication

Interventions

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Continuous Positive Airway Pressure

CPAP indication

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years of age treated with CPAP based on the diagnosis of OSAS (clinical picture and AHI\> 10).

Exclusion Criteria

* Diagnosis of a psychiatric illness or dementia.
* Communication problems or inability to read and speak Spanish.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Montserrat Montaña

Principal Investigator, Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Montserrat Montaña, PHD

Role: PRINCIPAL_INVESTIGATOR

Corporacion Parc Tauli

Locations

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CorporacionPT

Sabadell, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Montserrat Montaña, PhD

Role: CONTACT

+34692617376

Maria José Masdeu, MD

Role: CONTACT

+34937231010 ext. 21191

Facility Contacts

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Montserrat Montaña, PhD

Role: primary

+34692617376

Maria José Masdeu, MD

Role: backup

+34937231010 ext. 21191

Other Identifiers

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2018569

Identifier Type: -

Identifier Source: org_study_id

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