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

March 23, 2021 updated by: Montserrat Montaña, Corporacion Parc Tauli

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

405

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • CorporacionPT
        • Contact:
        • Contact:
        • Principal Investigator:
          • Montserrat Montaña, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with OSAS and who underwent treatment with Continuous Positive Airway Pressure at the Hospital de Sabadell.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients SAHS with CPAP
Continuous Positive Airway Pressure treatment
Device: Continuous Positive Airway Pressure
CPAP indication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence rate to CPAP treatment
Time Frame: 1 year after starting treatment
% of patients who still use CPAP
1 year after starting treatment
Ratio of patients with compliance with the treatment
Time Frame: 1 year after starting treatment
% of patients use CPAP ≥4h / night
1 year after starting treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Montserrat Montaña, PHD, Corporación Parc Taulí

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

December 13, 2018

First Submitted That Met QC Criteria

December 13, 2018

First Posted (Actual)

December 14, 2018

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018569

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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