NCT04124848

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
68mo left

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Oct 2019Dec 2031

First Submitted

Initial submission to the registry

October 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 11, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

October 25, 2019

Completed
12.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

12.2 years

First QC Date

October 7, 2019

Last Update Submit

September 12, 2025

Conditions

Obstructive Sleep Apnea

Keywords

Somali-AmericansSleep Disordered BreathingCardiovascular DiseasesSex and Racial DifferencesRespiratory DisordersHypertensionDiabetesHealth Disparities

Outcome Measures

Primary Outcomes (2)

  • 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.

    10 years

  • 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.

    10 years

Secondary Outcomes (4)

  • 24 hour mean arterial pressure

    10 years

  • Vascular endothelial function

    10 years

  • Insulin sensitivity

    10 years

  • Body composition

    10 years

Study Arms (2)

Somali Descent

Study participants who are of Somali origin.

Non-Somali Descent

Study participants who are not of Somali origin.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population are individuals who are of Somali descent compared to those of different racial/ethnic origins.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (2)

  • 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. 2025 Mar 15:10.1007/s40615-025-02389-7. doi: 10.1007/s40615-025-02389-7. Online ahead of print.

    PMID: 40088388DERIVED

  • 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.

    PMID: 39502777DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood plasma, buffy coat, and serum.

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea SyndromesCardiovascular DiseasesCoitusRespiration DisordersHypertensionDiabetes Mellitus

Condition Hierarchy (Ancestors)

ApneaRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSexual BehaviorBehaviorVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Virend Somers, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Somers CPL Lab

CONTACT

507-422-3499CPLSOMALI@mayo.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2019

First Posted

October 11, 2019

Study Start

October 25, 2019

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2031

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)