Adherence to CPAP in Patients With OSA. Ten Year Follow up

NCT ID: NCT03644121

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-08-01
• Study Completion Date: 2018-07-06

Brief Summary

The management of OSA is aimed to improve symptoms and mitigate reduce other health consequences. Continuous Positive Airway Pressure (CPAP) is the recognized treatment for OSA, able to reverse the pathophysiology of OSA and improving sleep continuity, resulting in improvements in daytime sleepiness and quality of life (QoL). However, low adherence to this treatment reduces the potential to achieve these benefits. The aim of this real life retrospective observational study was to assess the adherence to CPAP at 12 month and 10 years. The investigators evaluated also predicitve factors of adherence.

Detailed Description

Methods The protocol was approved (2215 CE, June, 19, 2018) by the Ethical Committee of the Istituti Clinici Scientifici (ICS) Maugeri, Pavia, Italy. All patients at admission to the Scientific Institute of Tradate gave the informed consent to the scientific use of their data.

Study Participants This study was conducted on a database of patients' discharge records, available between August, 2006 and December, 2009.

Adaptation to CPAP: titration of CPAP was performed either by full-night manual titration according to the AASM Guidelines or by automatic titration with Auto-Set systems. Further 4 day-time hours of adaptation were performed along two days. Patients underwent also four face to face sessions with the respiratory therapist, for feed-back of adaptation, optimal comprehension of procedure of CPAP management. The presence of a caregiver (if any) was strongly suggested.

Statistical Analysis An ad hoc electronic form was created to collect all study variables. Qualitative variables were described with absolute and relative (percentages) frequencies, whereas quantitative variables were summarized with means (standard deviations) or medians (interquartile ranges) based on their normal distribution, respectively.

In-between comparison for qualitative and quantitative variables was performed with the chi-squared or Fisher exact test when appropriate, and Student t or Mann-Whitney test in case of parametric or non-parametric distribution, respectively. Comparison of the temporal variation of continuous variables for the same group was assessed with Anova or Friedman's test, depending on their normal distribution.

Uni- and multi-variable logistic regression analysis was performed to assess which covariates could be associated with the adherence to CPAP.

A two-tailed p-value <0.05 was considered significant. All statistical analyses were carried out using the statistical software STATA version 15 (StatsCorp, Texas).

Conditions

OSA; Adherence, Patient; CPAP

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• diagnosis of OSA
• admitted for adaptation to CPAP

Exclusion Criteria

• other sleep related diseases
• concomitant lung or thoracic diseases (including chronic respiratory failure requiring long term oxygen therapy)
• major comorbidities (e.g. psychiatric conditions, cancer, end-stage renal failure)
• familiar conditions preventing long-term home CPAP
• patients already treated with CPAP

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maugeri Foundation

OTHER

Sponsor Role: lead

Responsible Party

elisabetta zampogna

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Spanevello, Prof MD

Role: STUDY_DIRECTOR

Maugeri Foundation, Insubria University

Locations

Maugeri Foundation

Tradate, VA, Italy

Countries

Italy

Other Identifiers

2215CE

Identifier Type: -

Identifier Source: org_study_id