Obstructive Sleep Apnea Among Somali-Americans (Somali OSA)

September 12, 2025 updated by: Virend Somers, MD, PhD, Mayo Clinic

Evaluating the Prevalence and Implications of Obstructive Sleep Apnea Among Somali-Americans: A Translational Research Study

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Virend Somers, MD, 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
        • Contact:
          • CPL
          • Phone Number: 507-422-3499

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years
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.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 hour mean arterial pressure
Time Frame: 10 years
Ambulatory measure of blood pressure in mmHg
10 years
Vascular endothelial function
Time Frame: 10 years
Change in brachial artery diameter in response to hyperemia
10 years
Insulin sensitivity
Time Frame: 10 years
Oral glucose tolerance testing
10 years
Body composition
Time Frame: 10 years
Percentage body fat content
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Sleep Number Corporation

Investigators

  • Principal Investigator: Virend Somers, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2019

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

October 7, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (Actual)

October 11, 2019

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 12, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-000033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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