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

Sponsor
Maugeri Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT03644121
Collaborator
(none)
140
Enrollment
1
Location
143.1
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    140 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Adherence to Continuous Positive Airway Pressure in Patients With Obstructive Sleep Apnoea Syndrome. Ten Year Follow up
    Actual Study Start Date :
    Aug 1, 2006
    Actual Primary Completion Date :
    Jul 1, 2018
    Actual Study Completion Date :
    Jul 6, 2018

    Outcome Measures

    Primary Outcome Measures

    1. CPAP use [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]

      number of Night-time hours of use (device counter)

    Secondary Outcome Measures

    1. Body weight [once a year for 10 years]

      Kg

    2. Reported patients' day-time sleepiness [once a year for 10 years]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maugeri Foundation Tradate VA Italy 21049

    Sponsors and Collaborators

    • Maugeri Foundation

    Investigators

    • Study Director: Antonio Spanevello, Prof MD, Maugeri Foundation, Insubria University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    elisabetta zampogna, principal investigator, Maugeri Foundation
    ClinicalTrials.gov Identifier:
    NCT03644121
    Other Study ID Numbers:
    • 2215CE
    First Posted:
    Aug 23, 2018
    Last Update Posted:
    Aug 23, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 23, 2018