Study of Disrupted Sleep in Somali Americans
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Anyone under 18 years or over 70 years.
Positive pregnancy.
Trial 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.
Trial design
Design model
Ecologic or community
Time perspective
Prospective
Treatments tested in this trial
24 hour blood pressure (BP) monitoring
Diagnostic test24-hour ambulatory BP measuring device and blood pressures will be measured every 20 minutes to half hour
Polysomnography
Diagnostic testMeasurements 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.
Treatment groups
240 Participants
are divided into 1 treatment groupGroup A: Healthy Somali Americans2 interventions
Trial outcomes
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 hours2
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 hours3
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 hours4
Disrupted sleep
Number of subjects to have disrupted sleep as measured by the sleep study
Time frame
1 night sleep study, approximately 8-9 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov