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Clinical Trials/NCT03776084
NCT03776084
Unknown
Not Applicable

Evaluation of Compliance With CPAP Therapy in Patients Diagnosed With Obstructive Sleep Apnea Syndrome at the Hospital de Sabadell

Corporacion Parc Tauli1 site in 1 country405 target enrollmentJune 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Apnea, Obstructive
Sponsor
Corporacion Parc Tauli
Enrollment
405
Locations
1
Primary Endpoint
Ratio of patients with compliance with the treatment
Last Updated
5 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
September 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Corporacion Parc Tauli
Responsible Party
Principal Investigator
Principal Investigator

Montserrat Montaña

Principal Investigator, Clinical Research

Corporacion Parc Tauli

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Ratio of patients with compliance with the treatment

Time Frame: 1 year after starting treatment

% of patients use CPAP ≥4h / night

Adherence rate to CPAP treatment

Time Frame: 1 year after starting treatment

% of patients who still use CPAP

Study Sites (1)

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