Clinical trial NCT03644121: Adherence to CPAP in Patients With OSA. Ten Year Follow up
Official title: Adherence to Continuous Positive Airway Pressure in Patients With Obstructive Sleep Apnoea Syndrome. Ten Year Follow up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: OSA
Adherence, Patient
CPAP
Lead sponsor: Maugeri Foundation
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diagnosis of OSA. According to the International Classification of Sleep Disorders, OSA was defined as the presence of 5 or more obstructive respiratory events (apnea, hypopnea or respiratory effort-related arousal) per hour of sleep plus daytime or nighttime symptoms of OSA, alternatively as the presence of 15 or more obstructive respiratory events per hour of sleep

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).

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

Primary outcomes:
measure: CPAP use
timeFrame: Every 12 month for 10 years.Scale from 0 to 8 hours/night. Values >4,5 hours/night are considered to be a better outcome
Secondary outcomes:
measure: Body weight
timeFrame: once a year for 10 years
measure: Reported patients' day-time sleepiness
timeFrame: once a year for 10 years
Other outcomes:
Locations:
city: Tradate
country: Italy
facility: Maugeri Foundation
state: VA
Study officials:
affiliation: Maugeri Foundation, Insubria University
name: Antonio Spanevello, Prof MD
role: STUDY_DIRECTOR
References: