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NCT Number: NCT05411029

Study of Disrupted Sleep in Somali Americans

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Healthy Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Wake Disorders Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Virend Somers, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Other names: Sleep Study

Primary outcomes

  1. Undiagnosed sleep deficiency-short sleep

    Time frame: 1 night sleep study, approximately 8-9 hours

    Number of subjects to have short sleep (<6 hours) as measured by the sleep study

  2. Undiagnosed sleep deficiency-insomnia

    Time frame: 1 night sleep study, approximately 8-9 hours

    Number of subjects to have insomnia as measured by the sleep study

  3. Undiagnosed sleep deficiency-obstructive sleep apnea (OSA)

    Time frame: 1 night sleep study, approximately 8-9 hours

    Number of subjects to have OSA as measured by the sleep study

  4. Disrupted sleep

    Time frame: 1 night sleep study, approximately 8-9 hours

    Number of subjects to have disrupted sleep as measured by the sleep study

  5. Blood pressure (BP) during wakefulness

    Time frame: Day 2

    Average BP as measured by 24 hour BP monitoring, reported in mmHg

  6. Blood pressure (BP) during sleep

    Time frame: Day 2

    Average BP as measured by 24 hour BP monitoring, reported in mmHg

Study contacts

Contact information is provided by the study sponsor or research team.

Somers CPL Lab

CONTACT

[email protected]

507-422-3499

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Disrupted Sleep in Somali Americans - Implications for Hypertension Risk

Important dates

Study start
2022
Primary completion
2031
Study completion
2031
First posted
Jun 8, 2022
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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