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NCT Number: NCT04124848

Obstructive Sleep Apnea Among Somali-Americans

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Behavior Cardiovascular Diseases Coitus Diabetes Mellitus Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Tract Diseases Sexual Behavior Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

C. Anwar A. Chahal, MBChB, PhD

SUB_INVESTIGATOR

CPL

CONTACT

507-422-3499

Erik K. St Louis, MD

SUB_INVESTIGATOR

Fowsiyo Ahmed, MBBS

SUB_INVESTIGATOR

Joyce E. Balls-Berry, PhD

SUB_INVESTIGATOR

Meghna P. Mansukhani, MD

SUB_INVESTIGATOR

Nasra H. Giama, DNP, RN

SUB_INVESTIGATOR

Virend Somers, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Somers CPL Lab

CONTACT

[email protected]

507-422-3499

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Sleep Number Corporation

Registry information

Official study title

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

Acronym: Somali OSA

Important dates

Study start
2019
Primary completion
2031
Study completion
2031
First posted
Oct 11, 2019
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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