Study of Disrupted Sleep in Somali Americans

Recruiting

• Conditions: Hypertension; Sleep Disorder; Healthy
• Interventions: Diagnostic Test: 24 hour blood pressure (BP) monitoring; Diagnostic Test: Polysomnography

• Registration Number: NCT05411029
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-08
• Study Start: 2022-11-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-28
• Primary Completion: 2029-07
• Study Completion: 2029-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Somali Americans	24 hour blood pressure (BP) monitoring	Somali Americans with no known history of hypertension, diabetes, or sleep disorders will have a 24 hour blood pressure monitoring and polysomnography.
Healthy Somali Americans	Polysomnography	Somali Americans with no known history of hypertension, diabetes, or sleep disorders will have a 24 hour blood pressure monitoring and polysomnography.

Primary Outcome Measures

Name	Time	Method
Blood pressure (BP) during sleep	Day 2	Average BP as measured by 24 hour BP monitoring, reported in mmHg
Disrupted sleep	1 night sleep study, approximately 8-9 hours	Number of subjects to have disrupted sleep as measured by the sleep study
Undiagnosed sleep deficiency-short sleep	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	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)	1 night sleep study, approximately 8-9 hours	Number of subjects to have OSA as measured by the sleep study
Blood pressure (BP) during wakefulness	Day 2	Average BP as measured by 24 hour BP monitoring, reported in mmHg

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States