Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT05411029

Conditions

Hypertension

Sleep Disorder

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

24 hour blood pressure (BP) monitoring

Polysomnography

Study Details

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

Study ID

NCT05411029

Start date

Nov 15, 2022

Status verified date

Sep, 2025

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

240 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

24 hour blood pressure (BP) monitoring

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

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Somers CPL Lab

507-422-3499CPLSOMALI@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Virend Somers, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 10, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-09-10.