Study of Disrupted Sleep in Somali Americans

Disrupted Sleep in Somali Americans - Implications for Hypertension Risk

The aims of this study are to determine the types and severity of previously undiagnosed sleep deficiencies in otherwise healthy Somali Americans, apply a research framework to define psychosocial, behavioral, environmental, and biological mechanisms mediating sleep deficiencies in Somali Americans, and examine the relationship between sleep deficiencies and increased blood pressure in Somali Americans.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Healthy; Sleep Disorder
• Intervention / Treatment: Diagnostic test: 24 hour blood pressure (BP) monitoring; Diagnostic test: Polysomnography

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Somers CPL Lab; Phone Number: 507-422-3499; Email: CPLSOMALI@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Virend Somers, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The research team will partner with Somali operated community-based health clinics, faith-based establishments, community organizations, charter schools and other educational/community centers. In addition, the research team will partner with the Somali Health Advisory Committee (SHAC), a community advisory board based in Rochester and Minneapolis/St. Paul and the Somali Community Resettlement Agency (SCRS) and Somali American Social Services Association (SASSA), two community organizations aimed at integrating Somali immigrants to the United States.

Description

Inclusion Criteria:

• Subjects diagnosed with no known history of hypertension, diabetes, or sleep disorders.
• Self-identify as Somali.
• Adult males and females who are older than 18 years of age.

Exclusion Criteria:

• Anyone under 18 years or over 70 years.
• Positive pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Healthy Somali Americans; Somali Americans with no known history of hypertension, diabetes, or sleep disorders will have a 24 hour blood pressure monitoring and polysomnography.

Diagnostic test: 24 hour blood pressure (BP) monitoring; 24-hour ambulatory BP measuring device and blood pressures will be measured every 20 minutes to half hour; Diagnostic test: Polysomnography; Measurements will include electroencephalogram, electromyogram, electrooculogram, electrocardiogram, breathing patterns of chest and abdomen, nasal and oral airflow and oxygen saturation. Sleep stages and apneas will be scored in accordance with validated American Academy of Sleep Medicine standards.; Other Names: Sleep Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Undiagnosed sleep deficiency-short sleep	Number of subjects to have short sleep (<6 hours) as measured by the sleep study	1 night sleep study, approximately 8-9 hours
Undiagnosed sleep deficiency-insomnia	Number of subjects to have insomnia as measured by the sleep study	1 night sleep study, approximately 8-9 hours
Undiagnosed sleep deficiency-obstructive sleep apnea (OSA)	Number of subjects to have OSA as measured by the sleep study	1 night sleep study, approximately 8-9 hours
Disrupted sleep	Number of subjects to have disrupted sleep as measured by the sleep study	1 night sleep study, approximately 8-9 hours
Blood pressure (BP) during wakefulness	Average BP as measured by 24 hour BP monitoring, reported in mmHg	Day 2
Blood pressure (BP) during sleep	Average BP as measured by 24 hour BP monitoring, reported in mmHg	Day 2

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Virend Somers, MD, Mayo Clinic

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypertension; Sleep Wake Disorders; Diagnostic Techniques and Procedures; Diagnosis; Circulatory and Respiratory Physiological Phenomena; Physical Examination; Vital Signs; Hemodynamics; Cardiovascular Physiological Phenomena; Monitoring, Physiologic; Blood Pressure; Polysomnography
• Other Study ID Numbers: 22-004192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No