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

C

Corporacion Parc Tauli

Status

Unknown

Conditions

Sleep Apnea, Obstructive

Treatments

Device: Continuous Positive Airway Pressure

Study type

Observational

Funder types

Other

Identifiers

NCT03776084
2018569

Details and patient eligibility

About

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.

Full 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.

Enrollment

405 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

405 participants in 1 patient group

Patients SAHS with CPAP
Description:
Continuous Positive Airway Pressure treatment
Treatment:
Device: Continuous Positive Airway Pressure

Trial contacts and locations

1

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Central trial contact

Montserrat Montaña, PhD; Maria José Masdeu, MD

Data sourced from clinicaltrials.gov

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