HypertensionNCT05411029
Study of Disrupted Sleep in Somali Americans
An observational study of Hypertension and Sleep Disorder, run by Mayo Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Sleep Disorder, Healthy
- What is being tested?
- 24 hour blood pressure (BP) monitoring and Polysomnography
- Type of treatment
- Pill or oral medicine
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2022to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- Anyone under 18 years or over 70 years.
- Positive pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Virend Somers, MD
About this study
Official title: Disrupted Sleep in Somali Americans - Implications for Hypertension Risk
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
- Being tested
- 24 hour blood pressure (BP) monitoring, Polysomnography
- Medical subject headings
- Hypertension, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 hour blood pressure (BP) monitoringDiagnostic test
24-hour ambulatory BP measuring device and blood pressures will be measured every 20 minutes to half hour
PolysomnographyDiagnostic test
Also called Sleep Study
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 24 hour blood pressure (BP) monitoring; Diagnostic Test: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undiagnosed sleep deficiency-short sleep
Number of subjects to have short sleep (<6 hours) as measured by the sleep study
Measured: 1 night sleep study, approximately 8-9 hours
Undiagnosed sleep deficiency-insomnia
Number of subjects to have insomnia as measured by the sleep study
Measured: 1 night sleep study, approximately 8-9 hours
Undiagnosed sleep deficiency-obstructive sleep apnea (OSA)
Number of subjects to have OSA as measured by the sleep study
Measured: 1 night sleep study, approximately 8-9 hours
Disrupted sleep
Number of subjects to have disrupted sleep as measured by the sleep study
Measured: 1 night sleep study, approximately 8-9 hours
Blood pressure (BP) during wakefulness
Average BP as measured by 24 hour BP monitoring, reported in mmHg
Measured: Day 2
Blood pressure (BP) during sleep
Average BP as measured by 24 hour BP monitoring, reported in mmHg
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start15 Nov 2022
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Virend Somers, MD, PhD, Mayo Clinic
- Investigators
- Virend Somers, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411029
- Sponsor's protocol ID
- 22-004192
- Other IDs
- R01HL160619
- Status last verified
- Sep 2026
- First submitted
- 6 Jun 2022
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greenlund IM, Bock JM, Govindan N, Kantas D, Singh P, Covassin N, Somers VK. Blood Pressure and Heart Rate Response to Orthostasis in Somali Americans. J Racial Ethn Health Disparities. 2026 Jun;13(3):1961-1966. doi: 10.1007/s40615-025-02389-7. Epub 2025 Mar 15.
PubMed 40088388Greenlund I, Bock J, Govindan N, Kantas D, Singh P, Covassin N, Somers V. Blood Pressure and Heart Rate Response to Orthostasis in Somali Americans. Res Sq [Preprint]. 2024 Oct 21:rs.3.rs-4925722. doi: 10.21203/rs.3.rs-4925722/v1.
PubMed 39502777
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disrupted Sleep in Somali Americans - Implications for Hypertension Risk
- ClinicalTrials.gov ID
- NCT05411029
- Acronym / sponsor ID
- 22-004192
- Conditions
- Hypertension, Sleep Disorder, Healthy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Somali Americans | – | Diagnostic Test: 24 hour blood pressure (BP) monitoring, Diagnostic Test: PolysomnographySomali Americans with no known history of hypertension, diabetes, or sleep disorders will have a 24 hour blood pressure monitoring and polysomnography. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Anyone under 18 years or over 70 years.
- Positive pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24 hour blood pressure (BP) monitoring24-hour ambulatory BP measuring device and blood pressures will be measured every 20 minutes to half hour | Diagnostic test | Healthy Somali Americans |
| PolysomnographyAlso: Sleep StudyMeasurements 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. | Diagnostic test | Healthy Somali Americans |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Derived from this study: PubMed 40088388Greenlund IM, Bock JM, Govindan N, Kantas D, Singh P, Covassin N, Somers VK. Blood Pressure and Heart Rate Response to Orthostasis in Somali Americans. J Racial Ethn Health Disparities. 2026 Jun;13(3):1961-1966. doi: 10.1007/s40615-025-02389-7. Epub 2025 Mar 15.
- Derived from this study: PubMed 39502777Greenlund I, Bock J, Govindan N, Kantas D, Singh P, Covassin N, Somers V. Blood Pressure and Heart Rate Response to Orthostasis in Somali Americans. Res Sq [Preprint]. 2024 Oct 21:rs.3.rs-4925722. doi: 10.21203/rs.3.rs-4925722/v1.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Virend Somers, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Sleep Disorder, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Somers CPL Lab (507-422-3499, CPLSOMALI@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Undiagnosed sleep deficiency-short sleep (time frame: 1 night sleep study, approximately 8-9 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05411029, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.