Obstructive Sleep ApneaSomali OSANCT04124848
Obstructive Sleep Apnea Among Somali-Americans
An observational study of Obstructive Sleep Apnea, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators seek to advance the understanding of obstructive sleep apnea as it relates to different ethnic origins as well as sex differences. The investigators will compare Somali patients with known obstructive sleep apnea (OSA) to individuals without OSA, and to individuals of other ethnic/racial origins to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2019to 31 Dec 2031
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population are individuals who are of Somali descent compared to those of different racial/ethnic origins.
Who may be able to join
- Self-identify as Somali, African, Asian, and European descent.
- Adult males and females who are older than 18 years of age.
Who cannot join
- Minors under 18 years or adults over 100 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
Rochester, Minnesota, 55905
CPL, 507-422-3499
Virend Somers, MD, PhD
About this study
Official title: Evaluating the Prevalence and Implications of Obstructive Sleep Apnea Among Somali-Americans: A Translational Research Study
The investigators seek to advance the understanding of obstructive sleep apnea as it relates to different ethnic origins as well as sex differences. The investigators will compare Somali patients with known obstructive sleep apnea (OSA) to individuals without OSA, and to individuals of other ethnic/racial origins to determine the risk factors (genetic and/or physiologic) associated with developing cardiovascular diseases. This will help the investigators to understand the unique sleep pathology of individuals of African descent.
Read the detailed description
Participants can be healthy volunteers or volunteers diagnosed with obstructive sleep apnea. All patients may undergo a sleep study (i.e. hospital or home-based), physical examination, questionnaires, blood and urine samples, ultrasound scan of the heart and brachial artery in the arm, CT scan, DEXA scan, paced breathing test, cardiopulmonary test and chemo-sensitivity test.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Somali-Americans, Sleep Disordered Breathing, Cardiovascular Diseases, Sex and Racial Differences, Respiratory Disorders, Hypertension, Diabetes, Health Disparities
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Cardiovascular Diseases, Coitus, Respiration Disorders, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Somali Descent | Study participants who are of Somali origin. | |
| Non-Somali Descent | Study participants who are not of Somali origin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the prevalence of obstructive sleep apnea
Measure the apnea-hypopnea index (AHI) to determine burden of obstructive sleep apnea. Based on the AHI, sleep apnea will be diagnosed if the AHI is ≥5 events/hour.
Measured: 10 years
To determine the severity of obstructive sleep apnea
The severity of OSA is classified based on the AHI as follows: None/Minimal: AHI < 5 per hour, Mild: AHI ≥ 5, but < 15 per hour, Moderate: AHI ≥ 15, but < 30 per hour, Severe: AHI ≥ 30 per hour.
Measured: 10 years
Secondary outcomes (4)
24 hour mean arterial pressure
Ambulatory measure of blood pressure in mmHg
Measured: 10 years
Vascular endothelial function
Change in brachial artery diameter in response to hyperemia
Measured: 10 years
Insulin sensitivity
Oral glucose tolerance testing
Measured: 10 years
Body composition
Percentage body fat content
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start25 Oct 2019
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Sleep Number Corporation
- 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
- NCT04124848
- Sponsor's protocol ID
- 19-000033
- Acronym
- Somali OSA
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2019
- Last updated
- 28 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 39502777Greenlund IM, Kantas D, Prakash SS, Bock JM, Covassin N, Somers VK. Nocturnal Hemodynamics in Somali Americans: Implications for Cardiovascular Risk. Am J Nephrol. 2024;55(6):629-637. doi: 10.1159/000540987. Epub 2024 Aug 24.
PubMed 39182475
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Prevalence and Implications of Obstructive Sleep Apnea Among Somali-Americans: A Translational Research Study
- ClinicalTrials.gov ID
- NCT04124848
- Acronym / sponsor ID
- Somali OSA / 19-000033
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Somali-Americans, Sleep Disordered Breathing, Cardiovascular Diseases, Sex and Racial Differences, Respiratory Disorders, Hypertension, Diabetes, Health Disparities
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Sleep Number Corporation
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 11 Oct 2019 (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 investigators seek to advance the understanding of obstructive sleep apnea as it relates to different ethnic origins as well as sex differences. The investigators will compare Somali patients with known obstructive sleep apnea (OSA) to individuals without OSA, and to individuals of other ethnic/racial origins to determine the risk factors (genetic and/or physiologic) associated with developing cardiovascular diseases. This will help the investigators to understand the unique sleep pathology of individuals of African descent.
Detailed description
Participants can be healthy volunteers or volunteers diagnosed with obstructive sleep apnea. All patients may undergo a sleep study (i.e. hospital or home-based), physical examination, questionnaires, blood and urine samples, ultrasound scan of the heart and brachial artery in the arm, CT scan, DEXA scan, paced breathing test, cardiopulmonary test and chemo-sensitivity test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Somali Descent | – | –Study participants who are of Somali origin. |
| Non-Somali Descent | – | –Study participants who are not of Somali origin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population are individuals who are of Somali descent compared to those of different racial/ethnic origins.
Key inclusion criteria (2 listed)
- Self-identify as Somali, African, Asian, and European descent.
- Adult males and females who are older than 18 years of age.
Key exclusion criteria (2 listed)
- Minors under 18 years or adults over 100 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.
Primary outcome
To assess the prevalence of obstructive sleep apnea
Time frame: 10 years
Measure the apnea-hypopnea index (AHI) to determine burden of obstructive sleep apnea. Based on the AHI, sleep apnea will be diagnosed if the AHI is ≥5 events/hour.
To determine the severity of obstructive sleep apnea
Time frame: 10 years
The severity of OSA is classified based on the AHI as follows: None/Minimal: AHI < 5 per hour, Mild: AHI ≥ 5, but < 15 per hour, Moderate: AHI ≥ 15, but < 30 per hour, Severe: AHI ≥ 30 per hour.
4 secondary outcomes
24 hour mean arterial pressure
Time frame: 10 years
Vascular endothelial function
Time frame: 10 years
Insulin sensitivity
Time frame: 10 years
Body composition
Time frame: 10 years
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 28 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.
- Derived from this study: PubMed 39182475Greenlund IM, Kantas D, Prakash SS, Bock JM, Covassin N, Somers VK. Nocturnal Hemodynamics in Somali Americans: Implications for Cardiovascular Risk. Am J Nephrol. 2024;55(6):629-637. doi: 10.1159/000540987. Epub 2024 Aug 24.
- Individual participant dataSharing planned: No
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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 Obstructive Sleep Apnea, 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 2 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 28 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?
To assess the prevalence of obstructive sleep apnea (time frame: 10 years). The study lists 2 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 NCT04124848, which also lists 3 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 28 Sep 2026.