An interventional study of Forced Desynchrony in Hypertension and Cardiovascular Risk Factor, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Basic science
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:
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 30 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
White adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
Behavioral: Forced Desynchrony
Black adults aged 30-60 with a BMI of 18.5\<BMI\<40 kg/m2 who are non-smokers (≥1 year), not on prescription medications (except oral contraceptives), and have had no recent shift work or major travel. Mild, unmanaged hypertension (below 160/100) and renal disease are allowed.
Behavioral: Forced Desynchrony
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 7 days in the laboratory
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).
| Milestone | White Adults | Black Adults |
|---|---|---|
| Started | 25 | 5 |
| Completed | 19 | 5 |
| Not completed | 6 | 0 |
| Withdrew: Adverse event | 6 | 0 |
Systolic blood pressure measured via automatic sphygmomanometer every 30 minutes during sleep period at baseline. Readings recorded in units of mmHg.
| mmHg | White Adults | Black Adults |
|---|---|---|
| Nighttime Systolic Blood Pressure | 101.6 ± 2.1 | 92.4 ± 4.0 |
Diastolic blood pressure measured via automatic sphygmomanometer every 30 minutes during sleep period at baseline. Readings recorded in units of mmHg.
| mmHg | White Adults | Black Adults |
|---|---|---|
| Nighttime Diastolic Blood Pressure | 60.5 ± 1.4 | 59.0 ± 1.4 |
Systolic blood pressure measured via automatic sphygmomanometer every 20 minutes during the daytime period at baseline. Readings recorded in units of mmHg.
| mmHg | White Adults | Black Adults |
|---|---|---|
| Daytime Systolic Blood Pressure | 116.6 ± 8.6 | 120.5 ± 9.7 |
Diastolic blood pressure measured via automatic sphygmomanometer every 20 minutes during the daytime period at baseline. Readings recorded in units of mmHg.
| mmHg | White Adults | Black Adults |
|---|---|---|
| Daytime Diastolic Blood Pressure | 68.1 ± 6.5 | 72.6 ± 7.2 |
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).
| mmHg/hour | White Adults | Black Adults |
|---|---|---|
| Change in Systolic Blood Pressure Across Sleep Period | -0.36 ± 0.5 | -0.6 ± 0.5 |
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).
| mmHg/hour | White Adults | Black Adults |
|---|---|---|
| Change in Diastolic Blood Pressure Across Sleep Period | -0.06 ± 0.14 | 0.4 ± 0.14 |
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.
| mmHg | White Adults | Black Adults |
|---|---|---|
| Circadian Amplitude of Systolic Blood Pressure When Awake | 2.2 ± 0.4 | 1.4 ± 0.8 |
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.
| mmHg | White Adults | Black Adults |
|---|---|---|
| Circadian Amplitude of Diastolic Blood Pressure When Awake | 0.8 ± 0.2 | 1.2 ± 0.6 |
Collected over From enrollment until end of follow-up (1 week after the in lab monitoring).. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| White Adults | 0/25 (0%) | 0/25 (0%) | 8/25 (32%) |
| Black Adults | 0/5 (0%) | 0/5 (0%) | 4/5 (80%) |
| Event | White Adults | Black Adults |
|---|---|---|
| Issues post dischargeGeneral disorders | 0/25 | 2/5 |
| Grip Test DiscomfortGeneral disorders | 0/25 | 2/5 |
| Participant withdraw from studyGeneral disorders | 6/25 | 0/5 |
| Lead DiscomfortGeneral disorders | 5/25 | 1/5 |
| Tilt Table DiscomfortGeneral disorders | 0/25 | 1/5 |
| General DiscomfortGeneral disorders | 1/25 | 1/5 |
| Study MealsGeneral disorders | 0/25 | 1/5 |
| Holter DiscomfortGeneral disorders | 0/25 | 1/5 |
| Blood Draw DiscontinuedGeneral disorders | 0/25 | 1/5 |
| ConstipationGeneral disorders | 1/25 | 0/5 |
Participants who did not complete the in lab study portion were excluded from all statistical analyses.
| Age, Continuous(Years) | White Adults | Black Adults | Total |
|---|---|---|---|
| Mean | 42.8 ± 10.0 | 45.2 ± 9.2 | 43.3 ± 9.7 |
| Sex: Female, Male(Participants) | White Adults | Black Adults | Total |
|---|---|---|---|
| Female | 11 | 2 | 13 |
| Male | 8 | 3 | 11 |
| Race (NIH/OMB)(Participants) | White Adults | Black Adults | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 5 | 5 |
| White | 19 | 0 | 19 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | White Adults | Black Adults | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 18 | 5 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oregon Health and Science University