Skip to main content
Clinical Trials/NCT04124848
NCT04124848
Recruiting
Not Applicable

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

Mayo Clinic1 site in 1 country600 target enrollmentOctober 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Mayo Clinic
Enrollment
600
Locations
1
Primary Endpoint
To assess the prevalence of obstructive sleep apnea
Status
Recruiting
Last Updated
7 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 25, 2019
End Date
December 31, 2031
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Virend Somers, MD, PhD

Principal Investigator

Mayo Clinic

Eligibility 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

Outcomes

Primary Outcomes

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.

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

  • Vascular endothelial function(10 years)
  • Insulin sensitivity(10 years)
  • 24 hour mean arterial pressure(10 years)
  • Body composition(10 years)

Study Sites (1)

Loading locations...

Similar Trials