Study of Disrupted Sleep in Somali Americans

NCT ID: NCT05411029

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-15

Study Completion Date

2031-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Sleep Disorder Healthy

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

24 hour blood pressure (BP) monitoring

Intervention Type DIAGNOSTIC_TEST

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

Polysomnography

Intervention Type 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.

Interventions

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24 hour blood pressure (BP) monitoring

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Sleep Study

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Virend Somers, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Virend Somers, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Somers CPL Lab

Role: CONTACT

507-422-3499

References

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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.

Reference Type DERIVED
PMID: 40088388 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39502777 (View on PubMed)

Other Identifiers

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22-004192

Identifier Type: -

Identifier Source: org_study_id

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