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

Sleep Apnea, Obstructive Clinical Trial

— CPAPSH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03776084
• Other study ID #: 2018569
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2021
• Source: Corporacion Parc Tauli
• Contact: Montserrat Montaña, PhD
• Phone: +34692617376
• Email: mmontana[@]tauli.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 405
• Est. completion date: September 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous Positive Airway Pressure
CPAP indication

Locations

Country	Name	City	State
Spain	CorporacionPT	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence rate to CPAP treatment	% of patients who still use CPAP	1 year after starting treatment
Primary	Ratio of patients with compliance with the treatment	% of patients use CPAP =4h / night	1 year after starting treatment