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| ID | Type | Description | Link |
|---|---|---|---|
| R35HL155681 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study will be the first to distinguish the relative contributions of sleep, circadian and behavioral mechanisms to the non-dipping BP profile in Black adults and will lay the groundwork for optimizing therapies dependent on mechanisms, such as targeting sleep, targeting circadian rhythmicity, or targeting behaviors, and raising the possibility that ideal therapy for hypertension (HTN) may differ by race. This research will ultimately help to improve health and survival in black populations with HTN.
By studying standardized behaviors and regulators of BP during sleep and behavioral stresses across all circadian phases, this protocol will allow us specifically to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| White Adults | White adults aged 30-60 with a BMI of 18.5\ |
| |
| Black Adults | Black adults aged 30-60 with a BMI of 18.5\ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forced Desynchrony | Behavioral | Participants will complete a 7-day circadian study protocol with numerous repeated blood pressure and other cardiovascular measures across the circadian cycle. All sleep opportunities and other activities will be scheduled by the experimenter so that by the end of the study these activities are spread evenly across all phases of the internal body clock. |
| Measure | Description | Time Frame |
|---|---|---|
| Nighttime Systolic Blood Pressure | Systolic blood pressure measured via automatic sphygmomanometer every 30 minutes during sleep period at baseline. Readings recorded in units of mmHg. | Baseline Night Average |
| Nighttime Diastolic Blood Pressure | Diastolic blood pressure measured via automatic sphygmomanometer every 30 minutes during sleep period at baseline. Readings recorded in units of mmHg. | Baseline Night Average |
| Daytime Systolic Blood Pressure | Systolic blood pressure measured via automatic sphygmomanometer every 20 minutes during the daytime period at baseline. Readings recorded in units of mmHg. | Baseline Daytime Average |
| Daytime Diastolic Blood Pressure | Diastolic blood pressure measured via automatic sphygmomanometer every 20 minutes during the daytime period at baseline. Readings recorded in units of mmHg. | Baseline Daytime Average |
| Change in Systolic Blood Pressure Across Sleep Period | Change in systolic blood pressure per hour of scheduled sleep period measured via automatic sphygmomanometer every 30 minutes across each of the scheduled sleep periods while participants stayed 7-nights and days in the laboratory. Sleep was scheduled to occur at varied times across the entire circadian cycle so that the effects of the circadian cycle can be ignored (i.e., averaged out). | 7 days in the laboratory |
| Change in Diastolic Blood Pressure Across Sleep Period | Change in diastolic blood pressure per hour of scheduled sleep period measured via automatic sphygmomanometer every 30 minutes across each of the scheduled sleep periods while participants stayed 7-nights and days in the laboratory. Sleep was scheduled to occur at varied times across the entire circadian cycle so that the effects of the circadian cycle can be ignored (i.e., averaged out). |
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Inclusion Criteria:
Exclusion Criteria:
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Black and White adults.
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| Name | Affiliation | Role |
|---|---|---|
| Steven A Shea, PhD | Ore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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Nothing to report
Participants were recruited from the general population using established methods via flyers across the OHSU campus, community bulletin boards, internet advertisements (ResearchMatch.com, OCTRI's research Data Warehouse, clinicaltrials.gov, Craigslist, Facebook-using lab or The Oregon Institute of Occupational Health Sciences accounts), and booths at community health fairs (see protocol for additional details).
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| ID | Title | Description |
|---|---|---|
| FG000 | White Adults | White adults aged 30-60 with a BMI of 18.5\ |
| FG001 | Black Adults | Black adults aged 30-60 with a BMI of 18.5\ |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who did not complete the in lab study portion were excluded from all statistical analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | White Adults | White adults aged 30-60 with a BMI of 18.5\ |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at screening |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nighttime Systolic Blood Pressure | Systolic blood pressure measured via automatic sphygmomanometer every 30 minutes during sleep period at baseline. Readings recorded in units of mmHg. | All participants who completed the in-laboratory study are included. | Posted | Mean | Standard Error | mmHg | Baseline Night Average |
|
From enrollment until end of follow-up (1 week after the in lab monitoring).
Participants were monitored by (1) nursing staff at least once every day (vital signs, and psychological wellbeing), (2) Research staff during physiological monitoring (blood pressure, heart rate and hemoglobin levels); (3) Regular subjective scales (exertion, sleepiness, etc.); and (4) Non-Systematic Assessment: participants encouraged to self-report any issues of physical or psychological discomfort throughout the study and up to one week after leaving the laboratory.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | White Adults | White adults aged 30-60 with a BMI of 18.5\ |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lead Discomfort | General disorders | Standard terminology | Non-systematic Assessment | Some participants reported localized discomfort associated with the placement of EEG electrodes and glue. Replacement or readjustment alleviated discomfort. One participant reported irritation related to the ECG adhesive but resolved after discharge. |
This is an observational study. Due to insufficient enrollment and an imbalanced group distribution, we do not have sufficient statistical power to fully interpret these data. The data are valuable as pilot data for future investigations and sample size estimation. While differences between White and Black participants were underpowered, in additional analyses we will examine effect of lifetime stress, as well as overall group circadian physiological responses to experimental conditions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole P. Bowles | Oregon Institute of Occupational Health Sciences, OHSU | 503-494-4273 | bowlesn@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2025 | Apr 13, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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plasma, saliva
|
| 7 days in the laboratory |
| Circadian Amplitude of Systolic Blood Pressure When Awake | Systolic blood pressure was assessed manually via sphygmomanometry during each scheduled wakefulness period while participants stayed 7-nights and days in the laboratory. Behaviors during wakefulness were standardized and scheduled to occur across the entire circadian cycle. Any systematic circadian rhythmicity was assessed by analysis of variance which revealed the underlying amplitude of the circadian rhythm of systolic blood pressure while controlling for (averaging out) any ongoing behaviors. | 7 days in the laboratory |
| Circadian Amplitude of Diastolic Blood Pressure When Awake | Diastolic blood pressure was assessed manually via sphygmomanometry during each scheduled wakefulness period while participants stayed 7-nights and days in the laboratory. Behaviors during wakefulness were standardized and scheduled to occur across the entire circadian cycle. Any systematic circadian rhythmicity was assessed by analysis of variance which revealed the underlying amplitude of the circadian rhythm of diastolic blood pressure while controlling for (averaging out) any ongoing behaviors. | 7 days in the laboratory |
| Black Adults |
Black adults aged 30-60 with a BMI of 18.5\ |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Sex recorded at screening. | Participants who did not complete the in lab study portion were excluded from all statistical analyses. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race recorded at screening. | Participants who did not complete the in lab study portion were excluded from all statistical analyses. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity recorded at screening. | Participants who did not complete the in lab study portion were excluded from all statistical analyses. | Count of Participants | Participants |
|
Black adults aged 30-60 with a BMI of 18.5\
|
|
| Primary | Nighttime Diastolic Blood Pressure | Diastolic blood pressure measured via automatic sphygmomanometer every 30 minutes during sleep period at baseline. Readings recorded in units of mmHg. | All participants who completed the in-laboratory study are included. | Posted | Mean | Standard Error | mmHg | Baseline Night Average |
|
|
|
| Primary | Daytime Systolic Blood Pressure | Systolic blood pressure measured via automatic sphygmomanometer every 20 minutes during the daytime period at baseline. Readings recorded in units of mmHg. | All participants who completed the in-laboratory study are included. | Posted | Mean | Standard Error | mmHg | Baseline Daytime Average |
|
|
|
| Primary | Daytime Diastolic Blood Pressure | Diastolic blood pressure measured via automatic sphygmomanometer every 20 minutes during the daytime period at baseline. Readings recorded in units of mmHg. | All participants who completed the in-laboratory study are included. | Posted | Mean | Standard Error | mmHg | Baseline Daytime Average |
|
|
|
| Primary | Change in Systolic Blood Pressure Across Sleep Period | Change in systolic blood pressure per hour of scheduled sleep period measured via automatic sphygmomanometer every 30 minutes across each of the scheduled sleep periods while participants stayed 7-nights and days in the laboratory. Sleep was scheduled to occur at varied times across the entire circadian cycle so that the effects of the circadian cycle can be ignored (i.e., averaged out). | All participants who completed the in-laboratory study are included. | Posted | Mean | Standard Error | mmHg/hour | 7 days in the laboratory |
|
|
|
| Primary | Change in Diastolic Blood Pressure Across Sleep Period | Change in diastolic blood pressure per hour of scheduled sleep period measured via automatic sphygmomanometer every 30 minutes across each of the scheduled sleep periods while participants stayed 7-nights and days in the laboratory. Sleep was scheduled to occur at varied times across the entire circadian cycle so that the effects of the circadian cycle can be ignored (i.e., averaged out). | All participants who completed the in-laboratory study are included. | Posted | Mean | Standard Error | mmHg/hour | 7 days in the laboratory |
|
|
|
| Primary | Circadian Amplitude of Systolic Blood Pressure When Awake | Systolic blood pressure was assessed manually via sphygmomanometry during each scheduled wakefulness period while participants stayed 7-nights and days in the laboratory. Behaviors during wakefulness were standardized and scheduled to occur across the entire circadian cycle. Any systematic circadian rhythmicity was assessed by analysis of variance which revealed the underlying amplitude of the circadian rhythm of systolic blood pressure while controlling for (averaging out) any ongoing behaviors. | All participants who completed the in-laboratory study are included. | Posted | Mean | Standard Error | mmHg | 7 days in the laboratory |
|
|
|
| Primary | Circadian Amplitude of Diastolic Blood Pressure When Awake | Diastolic blood pressure was assessed manually via sphygmomanometry during each scheduled wakefulness period while participants stayed 7-nights and days in the laboratory. Behaviors during wakefulness were standardized and scheduled to occur across the entire circadian cycle. Any systematic circadian rhythmicity was assessed by analysis of variance which revealed the underlying amplitude of the circadian rhythm of diastolic blood pressure while controlling for (averaging out) any ongoing behaviors. | All participants who completed the in-laboratory study are included. | Posted | Mean | Standard Error | mmHg | 7 days in the laboratory |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 8 |
| 25 |
| EG001 | Black Adults | Black adults aged 30-60 with a BMI of 18.5\ | 0 | 5 | 0 | 5 | 4 | 5 |
|
| Tilt Table Discomfort | General disorders | Standard terminology | Non-systematic Assessment | A participant reported right shoulder pain that was attributed to body positioning while on the tilt table. This was managed with towel support and heat as needed, and resolved post-test. |
|
| Constipation | General disorders | Standard terminology | Non-systematic Assessment | A participant reported constipation-related discomfort. Following consultation, a nurse provided prune juice to the participant, and the constipation resolved. |
|
| IV Site Discomfort | General disorders | Standard terminology | Non-systematic Assessment | In one participant the IV pump alarmed signaling potential occlusion, disturbing the participant's sleep. The pump was discontinued. Upon awakening a new IV was placed at an alternate site. |
|
| Participant withdraw from study | General disorders | Standard terminology | Non-systematic Assessment | Several participants experienced side effects (headache, vomiting, chest tightness) or discomfort, leading to early study termination or withdrawal. All symptomatic participants were evaluated and fully recovered afterward. |
|
| Issues post discharge | General disorders | Standard terminology | Non-systematic Assessment | One participants reported temporary delay in sleep schedule post-discharge, with gradual return to baseline. One participant noted a brief need to use reading glasses, likely due to prolonged reading in low-light conditions during the lab stay. |
|
| Grip Test Discomfort | General disorders | Standard terminology | Non-systematic Assessment | One participant reported hand muscle discomfort after the grip strength test, while another experienced temporary abdominal cramp and back pain during supine position, managed with a heating pad and later Advil. |
|
| Bike Test Discomfort | General disorders | Standard terminology | Non-systematic Assessment | The participant reported knee pain during the first bike test, likely related to prior overuse. |
|
| Stress Test Discomfort | General disorders | Standard terminology | Non-systematic Assessment | The participant experienced temporary nausea and lightheadedness during the stress test, accompanied by heart palpitations. The test was ended early and a study doctor was consulted, and an EKG showed no abnormality. |
|
| General Discomfort | General disorders | Standard terminology | Non-systematic Assessment | One participant reported temporary headache after awakening, while another noted mild temporary headache with mild chest tightness which rapidly resolved naturally. |
|
| Blood Draw Discomfort | General disorders | Standard terminology | Non-systematic Assessment | The participant experienced temporary nausea and dizziness during the tilt test blood draw. The test was halted and the IV was removed and further blood draws were cancelled. |
|
| Study Meals | General disorders | Standard terminology | Non-systematic Assessment | The participant disliked the repetitive tailored meals (peanut butter and bread), which were therefore changed to something more palatable. |
|
| Holter Discomfort | General disorders | Standard terminology | Non-systematic Assessment | The participant experienced discomfort when ECG leads were pushed onto the adhesive chest electrodes. Thus, we attached the leads to the adhesive chest electrodes before placing them on the participant. |
|
| Blood Draw Discontinued | General disorders | Standard terminology | Non-systematic Assessment | A participants hemoglobin was tested and close to cut off value. After consultation, the midline was removed and blood draws discontinued. |
|
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