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

NCT03644121 | Completed DMC

• 1 other identifier: 2215CE
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

OSA; Adherence, Patient; CPAP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Body weight

  once a year for 10 years

• Reported patients' day-time sleepiness

  once a year for 10 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• diagnosis of OSA
• admitted for adaptation to CPAP

You may not qualify if:

• 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

Sponsors & Collaborators

• Maugeri Foundation: lead

Study Sites (1)

Maugeri Foundation

Tradate, VA, 21049, Italy

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Antonio Spanevello, Prof MD

  Maugeri Foundation, Insubria University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 23, 2018
• Study Start: August 1, 2006
• Primary Completion: July 1, 2018
• Study Completion: July 6, 2018
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 4 month
• Access Criteria: free

Locations

IT (1)