Blood PressureNCT06285968
The DREAM Study: A Multidimensional Sleep Health Intervention for Improving Cardiometabolic Health
A study testing Multidimensional Sleep Health Promotion Intervention in people with Blood Pressure, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this randomized clinical trial is to evaluate the impact of a multidimensional sleep health promotion intervention on blood pressure, glycemic control indicators, anthropometric markers of adiposity, and lifestyle factors in adults. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Multidimensional Sleep Health Promotion Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2024to 30 Jun 2027
- Phase
- Interventional
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 30+ years
- English or Spanish speaking
- Systolic blood pressure greater than or equal to 120 mmHg
- Sub-optimal sleep health
- No history of overt cardiovascular disease
- No history of cancer
Who cannot join
- Optimal sleep health
- History of cardiovascular disease or cancer
- Non-English or non-Spanish speaking
- Not cognitively able to complete study requirements
- Severe psychiatric disorders
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nour Makarem, PhD contact
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center, Mailman School of Public Health
New York, New York, 10032
Nour Makarem, PhD, nm2968@cumc.columbia.edu
About this study
Official title: Addressing Sleep Duration, Regularity, and Efficiency: A Multidimensional Sleep Health Intervention for Improving Cardiometabolic Health (The DREAM Study)
The purpose of this randomized clinical trial is to evaluate the impact of a multidimensional sleep health promotion intervention on blood pressure, glycemic control indicators, anthropometric markers of adiposity, and lifestyle factors in adults. Participants will be randomized into an intervention or a control group. The control arm will receive standard Life's Essential 8 cardiovascular health educational materials. The intervention arm will additionally receive a multi-component intervention aimed at improving sleep health based on evidence-based sleep hygiene education and established behavior change techniques that include personalized sleep health feedback, goal setting and establishing a sleep health plan, coaching, self-monitoring, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation determinants, processes, and outcomes, ensuring the successful completion and future expansion of this intervention.
Read the detailed description
Improving multiple domains of cardiometabolic health through contextual behavioral interventions can have far-reaching effects for reducing the burden of multiple cardiometabolic morbidities. Despite a strong evidence base supporting the role of sleep as a major contributor to cardiometabolic health preservation, most lifestyle interventions have targeted diet or physical activity and not sleep. Sleep is amenable to intervention and can improve cardiometabolic health through complementary or synergistic biologic pathways with other lifestyle factors. Therefore, pragmatic multidimensional sleep health interventions may elucidate scalable and sustainable contextual behavioral approaches to improve cardiometabolic health and extend healthspan.
- Conditions
- Blood Pressure
- Being tested
- Multidimensional Sleep Health Promotion Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidimensional Sleep Health Promotion InterventionBehavioural
Multi-component multidimensional sleep health promotion intervention that includes goal setting, action planning, sleep health coaching and sleep hygiene education, a fixed sleep schedule, self-monitoring, personalized feedback and supportive accountability, and addressing light and noise in the sleep environment.
| Study group | Role | What they receive |
|---|---|---|
| Multidimensional Sleep Health Promotion Intervention | Experimental | Participants randomized to the intervention arm will receive:
1. A multi-component multidimensional sleep health promotion intervention that includes report back of sleep health profiles, S.M.A.R.T. goal setting, sleep health coaching, establishment of fixed sleep schedule, virtual sleep hygiene education, self-monitoring, personalized feedback and supportive accountability, and addressing light and noise in the sleep environment.
2. Cardiovascular health education materials based on the American Heart Association's Life's Essential 8 framework. Receives: Behavioral: Multidimensional Sleep Health Promotion Intervention |
| Standard of care | No intervention | Participants randomized to the control arm will receive standard American Heart Association Life's Essential 8 cardiovascular health education materials, providing guidance on healthy sleep duration only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in office systolic blood pressure
The change office systolic blood pressure (mmHg) from baseline to follow-up at 8 weeks will be calculated and compared across randomization arms.
Measured: Baseline, 8 weeks
Secondary outcomes (27)
Change in office systolic blood pressure (sustained effect at 24 weeks)
The change office systolic blood pressure (mmHg) from baseline to follow-up at 24 weeks will be calculated and compared across randomization arms.
Measured: Baseline, 24 weeks
Change in office diastolic blood pressure
The change office diastolic blood pressure (mmHg) from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.
Measured: Baseline, 8 weeks, and 24 weeks
Change in daytime blood pressure (during wake)
Mean daytime blood pressure (mean of blood pressure readings during the wake period) will be computed using valid readings from 24-h ambulatory blood pressure monitoring. Changes in out-of-office daytime blood pressure metrics from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.
Measured: Baseline, 8 weeks, and 24 weeks
Change in nighttime blood pressure (during sleep)
Mean nighttime blood pressure (mean of blood pressure readings during the sleep period) will be computed using valid readings from 24-h ambulatory blood pressure monitoring. Changes in out-of-office nighttime blood pressure metrics from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.
Measured: Baseline, 8 weeks, 24 weeks
Change in mean 24-hour blood pressure
Mean 24-h blood pressure (mean of the wake and sleep blood pressure values, weighted by the relative amounts of time spent awake and asleep) will be computed using valid readings from 24-h ambulatory blood pressure monitoring. Changes in these out-of-office blood pressure metrics from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.
Measured: Baseline, 8 weeks, 24 weeks
Change in fasting glucose
The change in fasting glucose (mg/dl) from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.
Measured: Baseline, 8 weeks, and 24 weeks
Change in body weight
The change in body weight (lbs) from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.
Measured: Baseline, 8 weeks, and 24 weeks
Change in waist circumference
The change in waist circumference (inches) from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.
Measured: Baseline, 8 weeks, and 24 weeks
Change in diet quality
The Mediterranean Eating Pattern for Americans (MEPA) scale, which captures adherence to a heart healthy dietary pattern, will be used to assess diet quality. The MEPA score ranges from 0-16 with higher scores indicating better diet quality. The change in MEPA scores from baseline to 8 weeks and 24 weeks will be calculated and compared across randomization arms.
Measured: Baseline, 8 weeks, and 24 weeks
Change in multidimensional sleep health
Sleep health will be assessed using sleep duration, regularity, efficiency, and timing from wrist actigraphy and self-reported sleep satisfaction and alertness (measured by daytime sleepiness). Optimal sleep health will be defined as having an average sleep duration (hours/night) ≥7 hours and <9 hours, regular sleep duration and timing (standard deviation of sleep duration and timing variables <90 minutes), sleep efficiency (%) ≥85%, an earlier sleep period (sleep midpoint earlier than 4:00 AM), normal daytime sleepiness (Epworth Sleepiness Scale ≤10), and good self-rated sleep satisfaction and quality. Sleep health will be assessed at baseline, 8 weeks, and 24 weeks. Changes in sleep health from baseline to follow-up at 8 weeks and 24 weeks will be calculated and compared across randomization arms.
Measured: Baseline, 8 weeks, and 24 weeks
Changes in sleep duration
Sleep duration will be assessed from wrist actigraphy. Optimal sleep duration will be defined as having an average sleep duration (hours/night) ≥ 7 hours and < 9 hours, given a score of 1 if met or 0 if not. Changes in sleep duration (continuous variable) from baseline to 8 weeks and 24 weeks will be assessed and compared across randomization arms.
Measured: Baseline, 8 weeks, 24 weeks
Changes in sleep regularity
Sleep regularity will be assessed from wrist actigraphy. Optimal sleep regularity will be defined as having a standard deviation of sleep duration and timing variables < 60 minutes, given a score of 1 if met or 0 if not. Changes in sleep duration SD and sleep timing SD (continuous variable) from baseline to 8 weeks and 24 weeks will be assessed and compared across randomization arms.
Measured: Baseline, 8 weeks, 24 weeks
Changes in sleep efficiency
Sleep efficiency will be assessed from wrist actigraphy. Optimal sleep efficiency will be defined as having an average sleep efficiency (%) ≥ 85%, given a score of 1 if met or 0 if not. Changes in sleep efficiency (continuous variable) from baseline to 8 weeks and 24 weeks will be assessed and compared across randomization arms.
Measured: Baseline, 8 weeks, 24 weeks
Changes in sleep timing
Sleep timing will be assessed from wrist actigraphy. Optimal sleep timing will be defined as having an earlier sleep period (sleep midpoint earlier than 4:00 AM), given a score of 1 if met or 0 if not. Changes in sleep timing (continuous variable) from baseline to 8 weeks and 24 weeks will be assessed and compared across randomization arms.
Measured: Baseline, 8 weeks, 24 weeks
Changes in sleep alertness
Sleep alertness will be assessed from the self reported Epworth Sleepiness Scale (ESS). Optimal sleep alertness will be defined as having normal daytime sleepiness (ESS ≤ 10). Scores range from 0-24, where a score ≥ 11 indicated excessive daytime sleepiness. Changes in the ESS score (continuous variable) from baseline to 8 weeks and 24 weeks will be assessed and compared across randomization arms.
Measured: Baseline, 8 weeks, 24 weeks
Changes in sleep satisfaction
Sleep satisfaction will be assessed from the consensus sleep diary. Sleep satisfaction is measured on a Likert scale (1 = very poor; 2 = poor; 3 = fair; 4 = good; 5 = very good). Change in sleep satisfaction from baseline to 8 weeks and 24 weeks will be assessed and compared across randomization arms.
Measured: Baseline, 8 weeks, 24 weeks
Changes in subjective sleep quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which captures seven clinical components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction) over the past month. The PSQI score ranges from 0-21 with higher scores suggesting significant sleep difficulties. The change in PSQI scores from baseline to follow-up at 8 weeks and 24 weeks will be assessed and compared across randomization arms.
Measured: Baseline, 8 weeks, 24 weeks
Change in depression severity
The Patient Health Questionnaire-8 (PHQ-8) measures depression symptom severity over the past two weeks, will be used to measure the severity of depression and screen for depressive disorders. The PHQ-8 scores range from 0-24 with higher scores indicating higher depression severity. The change in PHQ-8 scores from baseline to 8 weeks and 24 weeks will be calculated and compared across randomization arms.
Measured: Baseline, 8 weeks, 24 weeks
Change in anxiety severity
The Generalized Anxiety Disorder-7 (GAD-7) measures anxiety symptom severity over the past two weeks, will be used to screen for generalized anxiety disorder and measure the severity of anxiety. The GAD-7 scores range from 0-21 with higher scores indicating higher levels of anxiety. The change in GAD-7 scores from baseline to 8 weeks and 24 weeks will be calculated and compared across randomization arms.
Measured: Baseline, 8 weeks, 24 weeks
Change in perceived stress
The Perceived Stress Scale (PSS-10), which helps identify if individuals feel their lives are overloaded, unpredictable, or uncontrollable will be used to measure subjective perception of stress. The PSS-10 scores range from 0-40 with higher scores indicating higher perceived stress. The change in PSS-10 scores from baseline to 8 weeks and 24 weeks will be calculated.
Measured: Baseline, 8 weeks, 24 weeks
Change in perceived social support
The ENRICHD Social Support Instrument (ESSI) measures perceived emotional and instrumental support. The ESSI scores range from 8 to 34 with higher scores indicating higher levels of support and low support is generally defined as total score ≤ 18 and a score of ≤ 3 on two or more items. The change in ESSI scores from baseline to 8 weeks and 24 weeks will be calculated and compared across randomization arms.
Measured: Baseline, 8 weeks, 24 weeks
Self-rated health
Participant will rate their health as excellent, very good, good, fair, or poor at baseline to 8 weeks and 24 weeks. Changes in self-rated health from baseline to 8 weeks and 24 weeks as well as the differences in mean self-rated health will be compared across the randomization arms.
Measured: Baseline, 8 weeks, 24 weeks
Acceptability of Implementation
Acceptability will be measured by questionnaire. Items are adapted from the validated Acceptability of Implementation Measure (AIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better intervention acceptability. The items are analyzed individually and not summed to a total score.
Measured: 8 weeks and 24 weeks
Appropriateness of Implementation
Appropriateness will be measured by questionnaire. Items are adapted from the validated Implementation Appropriateness Measure (IAM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better appropriateness. The items are analyzed individually and not summed to a total score.
Measured: 8 weeks and 24 weeks
Feasibility of Implementation
Feasibility will be measured by questionnaire using items adapted from the validated Feasibility of Implementation Measure (FIM) and rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better feasibility. The items are analyzed individually and not summed to a total score.
Measured: 8 weeks and 24 weeks
Satisfaction with intervention
Net promoter score and questions about satisfaction with various intervention components.
Measured: 8 weeks and 24 weeks
Qualitative feedback from interviews on intervention feasibility and implementation
Qualitative feedback on satisfaction, feasibility, acceptability, appropriateness, and scalability will be gathered from participants and staff
Measured: 8 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start12 Mar 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Nour Makarem, PhD, Columbia University
- Investigators
- Nour Makarem, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285968
- Sponsor's protocol ID
- AAAU8937
- Other IDs
- P50MD017341
- Status last verified
- May 2026
- First submitted
- 13 Feb 2024
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Sleep Duration, Regularity, and Efficiency: A Multidimensional Sleep Health Intervention for Improving Cardiometabolic Health (The DREAM Study)
- ClinicalTrials.gov ID
- NCT06285968
- Acronym / sponsor ID
- AAAU8937
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Feb 2024 (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 purpose of this randomized clinical trial is to evaluate the impact of a multidimensional sleep health promotion intervention on blood pressure, glycemic control indicators, anthropometric markers of adiposity, and lifestyle factors in adults. Participants will be randomized into an intervention or a control group. The control arm will receive standard Life's Essential 8 cardiovascular health educational materials. The intervention arm will additionally receive a multi-component intervention aimed at improving sleep health based on evidence-based sleep hygiene education and established behavior change techniques that include personalized sleep health feedback, goal setting and establishing a sleep health plan, coaching, self-monitoring, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation determinants, processes, and outcomes, ensuring the successful completion and future expansion of this intervention.
Detailed description
Improving multiple domains of cardiometabolic health through contextual behavioral interventions can have far-reaching effects for reducing the burden of multiple cardiometabolic morbidities. Despite a strong evidence base supporting the role of sleep as a major contributor to cardiometabolic health preservation, most lifestyle interventions have targeted diet or physical activity and not sleep. Sleep is amenable to intervention and can improve cardiometabolic health through complementary or synergistic biologic pathways with other lifestyle factors. Therefore, pragmatic multidimensional sleep health interventions may elucidate scalable and sustainable contextual behavioral approaches to improve cardiometabolic health and extend healthspan.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidimensional Sleep Health Promotion Intervention | Experimental | Behavioral: Multidimensional Sleep Health Promotion InterventionParticipants randomized to the intervention arm will receive: 1. A multi-component multidimensional sleep health promotion intervention that includes report back of sleep health profiles, S.M.A.R.T. goal setting, sleep health coaching, establishment of fixed sleep schedule, virtual sleep hygiene education, self-monitoring, personalized feedback and supportive accountability, and addressing light and noise in the sleep environment. 2. Cardiovascular health education materials based on the American Heart Association's Life's Essential 8 framework. |
| Standard of care | No intervention | –Participants randomized to the control arm will receive standard American Heart Association Life's Essential 8 cardiovascular health education materials, providing guidance on healthy sleep duration only. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 30+ years
- English or Spanish speaking
- Systolic blood pressure greater than or equal to 120 mmHg
- Sub-optimal sleep health
- No history of overt cardiovascular disease
Key exclusion criteria (6 listed)
- Optimal sleep health
- History of cardiovascular disease or cancer
- Non-English or non-Spanish speaking
- Not cognitively able to complete study requirements
- Severe psychiatric disorders
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 |
|---|---|---|
| Multidimensional Sleep Health Promotion InterventionMulti-component multidimensional sleep health promotion intervention that includes goal setting, action planning, sleep health coaching and sleep hygiene education, a fixed sleep schedule, self-monitoring, personalized feedback and supportive accountability, and addressing light and noise in the sleep environment. | Behavioural | Multidimensional Sleep Health Promotion Intervention |
Primary outcome
Change in office systolic blood pressure
Time frame: Baseline, 8 weeks
The change office systolic blood pressure (mmHg) from baseline to follow-up at 8 weeks will be calculated and compared across randomization arms.
27 secondary outcomes
Change in office systolic blood pressure (sustained effect at 24 weeks)
Time frame: Baseline, 24 weeks
Change in office diastolic blood pressure
Time frame: Baseline, 8 weeks, and 24 weeks
Change in daytime blood pressure (during wake)
Time frame: Baseline, 8 weeks, and 24 weeks
Change in nighttime blood pressure (during sleep)
Time frame: Baseline, 8 weeks, 24 weeks
Change in mean 24-hour blood pressure
Time frame: Baseline, 8 weeks, 24 weeks
Change in fasting glucose
Time frame: Baseline, 8 weeks, and 24 weeks
Change in body weight
Time frame: Baseline, 8 weeks, and 24 weeks
Change in waist circumference
Time frame: Baseline, 8 weeks, and 24 weeks
Change in diet quality
Time frame: Baseline, 8 weeks, and 24 weeks
Change in multidimensional sleep health
Time frame: Baseline, 8 weeks, and 24 weeks
Changes in sleep duration
Time frame: Baseline, 8 weeks, 24 weeks
Changes in sleep regularity
Time frame: Baseline, 8 weeks, 24 weeks
Changes in sleep efficiency
Time frame: Baseline, 8 weeks, 24 weeks
Changes in sleep timing
Time frame: Baseline, 8 weeks, 24 weeks
Changes in sleep alertness
Time frame: Baseline, 8 weeks, 24 weeks
Changes in sleep satisfaction
Time frame: Baseline, 8 weeks, 24 weeks
Changes in subjective sleep quality
Time frame: Baseline, 8 weeks, 24 weeks
Change in depression severity
Time frame: Baseline, 8 weeks, 24 weeks
Change in anxiety severity
Time frame: Baseline, 8 weeks, 24 weeks
Change in perceived stress
Time frame: Baseline, 8 weeks, 24 weeks
Change in perceived social support
Time frame: Baseline, 8 weeks, 24 weeks
Self-rated health
Time frame: Baseline, 8 weeks, 24 weeks
Acceptability of Implementation
Time frame: 8 weeks and 24 weeks
Appropriateness of Implementation
Time frame: 8 weeks and 24 weeks
Feasibility of Implementation
Time frame: 8 weeks and 24 weeks
Satisfaction with intervention
Time frame: 8 weeks and 24 weeks
Qualitative feedback from interviews on intervention feasibility and implementation
Time frame: 8 weeks and 24 weeks
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 29 May 2026.
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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.
Nour Makarem, PhD contact
Nour Makarem, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidimensional Sleep Health Promotion Intervention in people with Blood Pressure, run by Columbia University 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 6 inclusion and 6 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 29 May 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 Research Project Coordinator (212-305-3317, dream@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in office systolic blood pressure (time frame: Baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2026.