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A Prospective Observational Cohort to Study the Genetics of Obstructive Sleep Apnea and Associated Co-Morbidities

Sponsor
Ulysses Magalang MD (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01857427
Collaborator
(none)
5,000
Enrollment
1
Location
160
Duration (Months)
31.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to build a well characterized cohort of patients that will be used to determine the genetic variants associated with obstructive sleep apnea (OSA)and its co-morbidities.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of building the cohort is to allow the performance of genome-wide association studies with a large sample of patients that have been well-characterized using standardized procedures.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Observational Cohort to Study the Genetics of Obstructive Sleep Apnea and Associated Co-Morbidities
    Study Start Date :
    Aug 1, 2012
    Anticipated Primary Completion Date :
    Dec 1, 2025
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Sleep Questionnaire [upon enrollment]

      Responses to sleep questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    We will recruit subjects who are:

    • 18 years of age and older.

    • Willing and able to give informed consent

    AND any of the following:

    • PSG (polysomnogram)requested by a physician based on clinical grounds

    • AHI (Apnea-hypopnea index) ≥ 5 episodes per hour based on a prior PSG.

    Exclusion Criteria:

    Incapable of giving informed consent

    • Under the age of 18

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Suite 2600, Martha Morehouse Medical Pavilion Columbus Ohio United States 43221

    Sponsors and Collaborators

    • Ulysses Magalang MD

    Investigators

    • Principal Investigator: Ulysses Magalang, MD, Ohio State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ulysses Magalang MD, Professor of Internal Medicine, Ohio State University
    ClinicalTrials.gov Identifier:
    NCT01857427
    Other Study ID Numbers:
    • 2012H0214
    First Posted:
    May 20, 2013
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Apnea
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive

    Study Results

    No Results Posted as of Jan 21, 2022