Study of Disrupted Sleep in Somali Americans

Healthy Clinical Trial

Official title:

Disrupted Sleep in Somali Americans - Implications for Hypertension Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411029
• Other study ID #: 22-004192
• Status: Recruiting
• Start date: November 15, 2022
• Est. completion date: July 2029

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: Somers CPL Lab
• Phone: 507-422-3499
• Email: CPLSOMALI[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: July 2029
• Est. primary completion date: July 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Hypertension
• Sleep Disorder
• Sleep Wake Disorders

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Undiagnosed sleep deficiency-short sleep	Number of subjects to have short sleep (<6 hours) as measured by the sleep study	1 night sleep study, approximately 8-9 hours
Primary	Undiagnosed sleep deficiency-insomnia	Number of subjects to have insomnia as measured by the sleep study	1 night sleep study, approximately 8-9 hours
Primary	Undiagnosed sleep deficiency-obstructive sleep apnea (OSA)	Number of subjects to have OSA as measured by the sleep study	1 night sleep study, approximately 8-9 hours
Primary	Disrupted sleep	Number of subjects to have disrupted sleep as measured by the sleep study	1 night sleep study, approximately 8-9 hours
Primary	Blood pressure (BP) during wakefulness	Average BP as measured by 24 hour BP monitoring, reported in mmHg	Day 2
Primary	Blood pressure (BP) during sleep	Average BP as measured by 24 hour BP monitoring, reported in mmHg	Day 2

External Links

•   Mayo Clinic Clinical Trials