NCT05411029 · Mayo Clinic
Study of Disrupted Sleep in Somali Americans
What this study is about
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.
View original scientific description
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
Number of subjects to have short sleep (\<6 hours) as measured by the sleep study
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
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
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
Blood pressure (BP) during wakefulness
Time frame: Day 2
Average BP as measured by 24 hour BP monitoring, reported in mmHg
Blood pressure (BP) during sleep
Time frame: Day 2
Average BP as measured by 24 hour BP monitoring, reported in mmHg
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Rochester, Minnesota
Collaborators
National Institutes of Health (NIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 10, 2025 · Source of record for eligibility and locations