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

OSA Clinical Trial

Official title:

Adherence to Continuous Positive Airway Pressure in Patients With Obstructive Sleep Apnoea Syndrome. Ten Year Follow up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644121
• Other study ID #: 2215CE
• Status: Completed
• Start date: August 1, 2006
• Est. completion date: July 6, 2018

Study information

• Verified date: August 2018
• Source: Maugeri Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 6, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Patient
• CPAP
• OSA

Locations

Country	Name	City	State
Italy	Maugeri Foundation	Tradate	VA

Sponsors (1)

Lead Sponsor	Collaborator
Maugeri Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPAP use	number of Night-time hours of use (device counter)	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	Body weight	Kg	once a year for 10 years
Secondary	Reported patients' day-time sleepiness	Epworth Sleepness Scale (ESS).The questionnaire asks the subject to rate his/her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought	once a year for 10 years