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RecruitingNCT04124848Somali OSAUpdated Sep 28, 2026

Obstructive Sleep Apnea Among Somali-Americans

An observational study in Obstructive Sleep Apnea, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Mayo Clinic · Observational

From the registry’s dates

  • Started Oct 2019; still recruiting 7 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • Somali-Americans
  • Sleep Disordered Breathing
  • Cardiovascular Diseases
  • Sex and Racial Differences
  • Respiratory Disorders
  • Hypertension
  • Diabetes
  • Health Disparities
03

In context

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's planned enrollment of 600 is above the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Minors under 18 years or adults over 100 years
  • Positive pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Somali Descent

    Study participants who are of Somali origin.

  • Non-Somali Descent

    Study participants who are not of Somali origin.

06

What researchers measure

Primary outcomes

  1. To assess the prevalence of obstructive sleep apnea

    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.

    Time frame: 10 years

  2. To determine the severity of obstructive sleep apnea

    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.

    Time frame: 10 years

Secondary outcomes

  1. 24 hour mean arterial pressure

    Ambulatory measure of blood pressure in mmHg

    Time frame: 10 years

  2. Vascular endothelial function

    Change in brachial artery diameter in response to hyperemia

    Time frame: 10 years

  3. Insulin sensitivity

    Oral glucose tolerance testing

    Time frame: 10 years

  4. Body composition

    Percentage body fat content

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
    Recruiting
    • CPL · Contact507-422-3499
    • Virend Somers, MD, PhD · Principal 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 · Sub investigator
08

References and documents

Publications

  • Greenlund IM, Bock JM, Govindan N, Kantas D, Singh P, Covassin N, Somers VK. Blood Pressure and Heart Rate Response to Orthostasis in Somali Americans. J Racial Ethn Health Disparities. 2026 Jun;13(3):1961-1966. doi: 10.1007/s40615-025-02389-7. Epub 2025 Mar 15. PubMed 40088388 ↗
  • Greenlund I, Bock J, Govindan N, Kantas D, Singh P, Covassin N, Somers V. Blood Pressure and Heart Rate Response to Orthostasis in Somali Americans. Res Sq [Preprint]. 2024 Oct 21:rs.3.rs-4925722. doi: 10.21203/rs.3.rs-4925722/v1. PubMed 39502777 ↗
  • Greenlund IM, Kantas D, Prakash SS, Bock JM, Covassin N, Somers VK. Nocturnal Hemodynamics in Somali Americans: Implications for Cardiovascular Risk. Am J Nephrol. 2024;55(6):629-637. doi: 10.1159/000540987. Epub 2024 Aug 24. PubMed 39182475 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04124848
Lead sponsor
Mayo Clinic
Collaborators
Sleep Number Corporation
Responsible party
Virend Somers, MD, PhD (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Oct 11, 2019
Start date
Oct 25, 2019
Primary completion
Dec 31, 2031 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Sep 28, 2026

Study contacts

Somers CPL Lab
Contact
CPLSOMALI@mayo.edu
507-422-3499
Virend Somers, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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