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RecruitingNCT05411029Updated Sep 14, 2026

Study of Disrupted Sleep in Somali Americans

An observational study in Hypertension, Sleep Disorder and Healthy, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Mayo Clinic · Observational

From the registry’s dates

  • Started Nov 2022; still recruiting 3 years 11 months later.
Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
240
Ages
18 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Hypertension
  • Sleep Disorder
  • Healthy
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In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 240 is below the median of 350 across 1,163 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
240 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic test24 hour blood pressure (BP) monitoring

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

  • Diagnostic testPolysomnography

    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

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What researchers measure

Primary outcomes

  1. Undiagnosed sleep deficiency-short sleep

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

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

  2. Undiagnosed sleep deficiency-insomnia

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

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

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

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

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

  4. Disrupted sleep

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

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

  5. Blood pressure (BP) during wakefulness

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

    Time frame: Day 2

  6. Blood pressure (BP) during sleep

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

    Time frame: Day 2

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Study locations

1 of 1 sites recruiting
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References and documents

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. PubMed 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. PubMed 39502777 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2022 (actual). Primary completion is estimated for Oct 2028, 71 months after the start.

Of 345 non-industry observational studies under Hypertension, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 111. This study's planned 71 months is above that.

Counting every sponsor, half of 426 studies reached it within 38 months; a quarter within 17 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 6, 2022
First posted
Jun 8, 2022
StartActual
Nov 15, 2022
Primary completionEst.
Oct 2028
CompletionEst.
Oct 2028
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05411029
Lead sponsor
Mayo Clinic
Responsible party
Virend Somers, MD, PhD (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jun 8, 2022
Start date
Nov 15, 2022
Primary completion
Oct 2028 (estimated)
Completion
Oct 2028 (estimated)
Last update
Sep 14, 2026

Study contacts

Somers CPL Lab
Contact
CPLSOMALI@mayo.edu
507-422-3499
Virend Somers, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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