Study of Disrupted Sleep in Somali Americans

NCT05411029 | Recruiting

• 1 other identifier: 22-004192
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Sleep Disorder; Healthy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

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; Diagnostic Test: Polysomnography

Interventions

24 hour blood pressure (BP) monitoring DIAGNOSTIC_TEST

24-hour ambulatory BP measuring device and blood pressures will be measured every 20 minutes to half hour

Healthy Somali Americans

Polysomnography DIAGNOSTIC_TEST

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.

Also known as: Sleep Study

Healthy Somali Americans

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Mayo Clinic in Rochester

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: 40088388 DERIVED

• 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: 39502777 DERIVED

MeSH Terms

Conditions

Hypertension; Sleep Wake Disorders

Interventions

Blood Pressure; Polysomnography

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Monitoring, Physiologic

Study Officials

• Virend Somers, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Somers CPL Lab

CONTACT

507-422-3499; CPLSOMALI@mayo.edu

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 8, 2022
• Study Start: November 15, 2022
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)