Obstructive Sleep Apnea Among Somali-Americans

Recruiting

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT04124848
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-11
• Study Start: 2019-10-25
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-28
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the prevalence of obstructive sleep apnea	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States