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Recruiting NCT05411029

Study of Disrupted Sleep in Somali Americans

Observational Hypertension Sleep Disorder Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 24 hour blood pressure (BP) monitoring, Polysomnography.
Who it may be relevant to
Registry conditions: Hypertension, Sleep Disorder, Healthy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Disrupted Sleep in Somali Americans - Implications for Hypertension Risk

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Undiagnosed sleep deficiency-short sleep [Time frame: 1 night sleep study, approximately 8-9 hours]
  • Undiagnosed sleep deficiency-insomnia [Time frame: 1 night sleep study, approximately 8-9 hours]
  • Undiagnosed sleep deficiency-obstructive sleep apnea (OSA) [Time frame: 1 night sleep study, approximately 8-9 hours]
  • Disrupted sleep [Time frame: 1 night sleep study, approximately 8-9 hours]
  • Blood pressure (BP) during wakefulness [Time frame: Day 2]
  • Blood pressure (BP) during sleep [Time frame: Day 2]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Ecologic or community

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

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. 2026 Jun;13(3):1961-1966. doi: 10.1007/s40615-025-02389-7. Epub 2025 Mar 15. PMID 40088388
  • 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

Identifiers

NCT: NCT05411029 · 22-004192

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗