Obstructive Sleep Apnea Among Somali-Americans

Obstructive Sleep Apnea Clinical Trial

— Somali OSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04124848
• Other study ID #: 19-000033
• Status: Recruiting
• Start date: October 25, 2019
• Est. completion date: December 31, 2028

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: Somers CPL Lab
• Phone: 507-422-3499
• Email: CPLSOMALI[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Sleep Number Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	24 hour mean arterial pressure	Ambulatory measure of blood pressure in mmHg	10 years
Secondary	Vascular endothelial function	Change in brachial artery diameter in response to hyperemia	10 years
Secondary	Insulin sensitivity	Oral glucose tolerance testing	10 years
Secondary	Body composition	Percentage body fat content	10 years

External Links

•   Mayo Clinic Clinical Trials