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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03776084
Other study ID # 2018569
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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