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PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Completed
CT.gov ID
NCT02591979
Collaborator
(none)
198
Enrollment
1
Location
43
Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to develop and validate a work-model in Primary Health Care for identifying patients with Sleep Apnea Syndrome, based on clinical variables and an ambulatory monitoring study.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    198 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment. A Multi-Centre Study to Validate a Sleep Apnea Screening Model in Primary Health Care
    Study Start Date :
    Mar 1, 2015
    Actual Primary Completion Date :
    Oct 1, 2018
    Actual Study Completion Date :
    Oct 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Apnea/Hypopnea Index [At baseline]

      At primary healthcare

    2. Apnea/Hypopnea Index [At 3 months]

      At Sleep Lab Unit

    Secondary Outcome Measures

    1. Cardiovascular risk factors [At baseline]

    2. History of cardiovascular or cerebrovascular disease [At baseline]

    3. Lung function tests [At baseline]

    4. Self-perceived sleepiness. Epworth Test [At baseline]

      At primary healthcare

    5. Self-perceived sleepiness. Epworth Test [At 3 months]

      At Sleep lab unit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients between 18 to 75 years.
    Exclusion Criteria:

    • Cognitive impairment or psycho-physical deterioration that impede to perform ambulatory monitoring study.

    • Worsened or unstable cardiovascular or cerebrovascular disease.

    • Chronic insomnia (<5h sleep / day).

    • Relevant respiratory comorbidity that could interfere with arterial saturation measurements, as moderate to severe chronic obstructive pulmonary disease.

    • Neuromuscular disease.

    • Refusal to participate in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Barcelona Spain 08025

    Sponsors and Collaborators

    • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    ClinicalTrials.gov Identifier:
    NCT02591979
    Other Study ID Numbers:
    • IIBSP-PAS-2013-151
    First Posted:
    Oct 30, 2015
    Last Update Posted:
    Mar 5, 2019
    Last Verified:
    Mar 1, 2019
    Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    Sleep Apnea Syndrome
    Primary Health Care
    Additional relevant MeSH terms:
    Apnea
    Sleep Apnea Syndromes
    Syndrome

    Study Results

    No Results Posted as of Mar 5, 2019