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Obstructive Sleep Apnea Among Somali-Americans (Somali OSA)

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ClinicalTrials.gov Identifier: NCT04124848
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Virend Somers, Mayo Clinic

Brief Summary:
The investigators seek to advance the understanding of obstructive sleep apnea as it relates to different ethnic origins as well as sex differences. The investigators will compare Somali patients with known obstructive sleep apnea (OSA) to individuals without OSA, and to individuals of other ethnic/racial origins to determine the risk factors (genetic and/or physiologic) associated with developing cardiovascular diseases. This will help the investigators to understand the unique sleep pathology of individuals of African descent.

Condition or disease
Obstructive Sleep Apnea

Detailed Description:
Participants can be healthy volunteers or volunteers diagnosed with obstructive sleep apnea. All patients may undergo a sleep study (i.e. hospital or home-based), physical examination, questionnaires, blood and urine samples, ultrasound scan of the heart and brachial artery in the arm, CT scan, DEXA scan, paced breathing test, cardiopulmonary test and chemo-sensitivity test.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating the Prevalence and Implications of Obstructive Sleep Apnea Among Somali-Americans: A Translational Research Study
Estimated Study Start Date : October 14, 2019
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort
Somali Descent
Study participants who are of Somali origin.
Non-Somali Descent
Study participants who are not of Somali origin.



Primary Outcome Measures :
  1. To assess the prevalence of obstructive sleep apnea [ Time Frame: 10 years ]
    Measure the apnea-hypopnea index (AHI) to determine burden of obstructive sleep apnea. Based on the AHI, sleep apnea will be diagnosed if the AHI is ≥5 events/hour.

  2. To determine the severity of obstructive sleep apnea [ Time Frame: 10 years ]
    The severity of OSA is classified based on the AHI as follows: None/Minimal: AHI < 5 per hour, Mild: AHI ≥ 5, but < 15 per hour, Moderate: AHI ≥ 15, but < 30 per hour, Severe: AHI ≥ 30 per hour.


Secondary Outcome Measures :
  1. 24 hour mean arterial pressure [ Time Frame: 10 years ]
    Ambulatory measure of blood pressure in mmHg

  2. Vascular endothelial function [ Time Frame: 10 years ]
    Change in brachial artery diameter in response to hyperemia

  3. Insulin sensitivity [ Time Frame: 10 years ]
    Oral glucose tolerance testing

  4. Body composition [ Time Frame: 10 years ]
    Percentage body fat content


Biospecimen Retention:   Samples With DNA
Blood plasma, buffy coat, and serum.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population are individuals who are of Somali descent compared to those of different racial/ethnic origins.
Criteria

Inclusion Criteria:

  • Self-identify as Somali, African, Asian, and European descent.
  • Adult males and females who are older than 18 years of age.

Exclusion Criteria:

  • Minors under 18 years or adults over 100 years
  • Positive pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124848


Contacts
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Contact: Essa Mohamed, PhD 507-255-4169 Mohamed.Essa@mayo.edu
Contact: Jasmine Sexton 507-538-7178 Sexton.Jasmine@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Essa Mohamed, PhD    507-255-4169    Mohamed.Essa@mayo.edu   
Contact: Jasmine Sexton    507-538-7178    Sexton.Jasmine@mayo.edu   
Principal Investigator: Virend Somers, MD, PhD         
Sub-Investigator: Essa A. Mohamed, PhD         
Sub-Investigator: Erik K. St Louis, MD         
Sub-Investigator: Meghna P. Mansukhani, MD         
Sub-Investigator: C. Anwar A. Chahal, MBChB, PhD         
Sub-Investigator: Nasra H. Giama, DNP, RN         
Sub-Investigator: Joyce E. Balls-Berry, PhD         
Sub-Investigator: Fowsiyo Ahmed, MBBS         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Virend Somers, MD Mayo Clinic

Additional Information:
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Responsible Party: Virend Somers, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04124848     History of Changes
Other Study ID Numbers: 19-000033
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virend Somers, Mayo Clinic:
Somali-Americans
Sleep Disordered Breathing
Cardiovascular Diseases
Sex and Racial Differences
Respiratory Disorders
Hypertension
Diabetes
Health Disparities
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases