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

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: Continuous Positive Airway Pressure

• Registration Number: NCT03776084
• Lead Sponsor: Corporacion Parc Tauli

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.

Study Timeline

• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-14
• Study Start: 2019-06-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-24
• Primary Completion: 2021-06-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 405

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients SAHS with CPAP	Continuous Positive Airway Pressure	Continuous Positive Airway Pressure treatment

Primary Outcome Measures

Name	Time	Method
Ratio of patients with compliance with the treatment	1 year after starting treatment	% of patients use CPAP ≥4h / night
Adherence rate to CPAP treatment	1 year after starting treatment	% of patients who still use CPAP

Trial Locations

Locations (1)

CorporacionPT; 🇪🇸 Sabadell, Barcelona, Spain