High Blood PressurePhase 2Amp-HTNNCT04346511
Acupuncture Treatment on Cerebral Blood Flow
A Phase 2 study testing Acupuncture in people with High Blood Pressure, run by University of Oklahoma at 1 site in United States.
Trial summary
Cerebrovascular diseases (CVD) and neurodegenerative diseases (NDD) are both leading causes of death in the United States. Epidemiological data have shown that increased prevalence of hypertension is related to these outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2020to 5 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will include healthy controls (CON) and Hypertension (HTN) patients between 18-65 years of age. Female participants if premenopausal will be studied in the early follicular phase of their cycle to minimize vascular effects of circulating hormones.
- HTN:
- 1) Stage 1 hypertensive, Systolic BP (SBP) ≥ 130 mmHg and/or Diastolic BP (DBP) > 80 mmHg, and/or diagnosis of HTN, with BMI and physical activity levels ≈ CON
- If they are on anti-hypertensive medication, the dose, type, and frequency of use will be recorded.
- HTN with an SBP > 139 mmHg must have a medical doctor's permission to participate
- CON: will be age, BMI, menstrual status for females, and physical activity matched to HTN. They must be:
- Normotensive
- Free of cardiovascular comorbidities.
Who cannot join
- Diabetes
- Coronary artery disease
- Stroke
- Heart attack
- Sleep apnea
- Tobacco use
Show all 10Show fewer
- Asthma
- Pregnancy
- Currently receiving antihypertensive acupuncture treatment
- conditions where acupuncture might not be safe, such as metal allergy or needle-phobia. If a subject experiences severe acupuncture-associated response, it will be subject to early termination of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Health and Exercise Science
Norman, Oklahoma, 73019
About this study
Official title: Effects of Anti-Hypertensive Acupuncture Treatment on Cerebral Blood Flow Responses to Exercise in Hypertensive Humans
Cerebrovascular diseases (CVD) and neurodegenerative diseases (NDD) are both leading causes of death in the United States. Epidemiological data have shown that increased prevalence of hypertension is related to these outcomes. However, despite the strong association of poor brain health outcomes in patients with hypertension (HTN), the understanding of cerebral blood flow (CBF) regulation and treatment options for HTN remain limited. Acupuncture treatment (AT), which is considered a promising complementary and integrative modality, has been known to reduce blood pressure and improve endothelial function in HTN. However, very few studies have investigated AT's effect on cerebrovascular function and the possible neuroprotective properties directly via regulating HTN. Exercise is used as a stimulus that increases the brain's metabolism and requires cerebrovascular responses (vasodilation) to meet the new metabolism.
Therefore, the specific aim of this study is to test the hypothesis that an antihypertensive acupuncture treatment can acutely improve cerebrovascular responses in hypertensive humans during moderate exercise.
Read the detailed description
After IRB approval, experiments will take place in the Human Circulation Research Laboratory in the Department of Health and Exercise on the OU Norman campus. All subjects will complete a total of 3 visits. The first is a screening visit to provide informed consent and to ensure the potential participant meets all inclusion criteria and no exclusion criteria. Once enrolled, participants will complete two experimental trials (Placebo (PL, Sham Acupuncture) or Real Acupuncture (RA), randomized) in a single-blinded crossover design. PL or RA treatment will precede testing by ~25min before to maximize acute responses. Test begins with 5 min of quiet rest where baseline measurements are taken, followed by 5 min of exercise. After exercise, subjects will be given 5 min of quiet rest.
Visit 1 (Screening day): ~1.5 hours. The screening visit will include informed consent, health history, physical activity questionnaires and blood sample. If qualified, the subject will be enrolled in the study and they will complete a maximal oxygen uptake (VO2max) cycle ergometer test to determine fitness.
Visit 2 \& 3 (Study day): ~1.5 hours. Instrumentation: Subjects will be equipped with ECG for heart rate (HR), photoplethysmography for blood pressure, pulse oximeter, mouthpiece for end-tidal CO2 (PETCO2) and oxygen uptake (VO2), near-infrared spectroscopy (NIRS) for active muscle oxygenation and Transcranial Doppler (TCD) for CBF. Real Acupuncture (RA): Subjects will receive ~20 minutes of RA treatment prior to exercise. Placebo (PL): Specially designed Sham Acupuncture needles will be used in the same acupoints, for the same duration as RA.
All subjects will complete a total of 3 visits separated by a minimum of 48 hours. Each study visit will take ~1.5 hours. The investigators anticipate ~ 6 hours or less of total involvement of the participants' time.
This study is a single-blind crossover design. Participants will be blinded in two trials. Practitioners and operators will not be allowed to communicate with the participants concerning the type of acupuncture devices. Outcome assessors and statisticians may not be blinded to treatment allocation.
The key dependent variable of interest is change (delta) in cerebrovascular conductance index (CVCi = CBF/blood pressure) from rest to exercise (delta CVCi = CVCiExercise - CVCiRest). Delta CVCi is the most common assessment of vasodilation in humans as it normalizes differences in blood flow to differences in blood pressure. CVCi calculates how much blood flow is observed for a given pressure. A change in CVCi (delta CVCi) has a predictable relationship where + delta CVCi indicates vasodilation (more flow for a given pressure) and - delta CVCi indicates vasoconstriction (less flow for a given pressure). Data will be analyzed using a general linear model approach (similar to ANOVA). Based on pilot data, a total sample size of 40 (20 CON and 20 HTN) will provide a power of 0.9. A minimum of 60 participants will be to recruited to ensure statistical power is achieved.
- Conditions
- High Blood Pressure
- Being tested
- Acupuncture
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Also called Sham Acupuncture
Patients will have six, 0.25*40mm sterilized stainless steel acupuncture needles (Dongbang Acupuncture, Inc., Seoul, South Korea) inserted into six acupoints (sites ST36, LV3, KI2, bilaterally) on their lower legs. After insertion, the needles will be stimulated at 2-4Hz, 10s at each point (1min total), immediately after insertion, 5min, 10min, 15min and just before removal.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | In a supine position with a cardboard blocking view of their legs, patients will have six, 0.25*40mm sterilized stainless steel acupuncture needles (Dongbang Acupuncture, Inc., Seoul, South Korea) inserted into six acupoints (sites ST36, LV3, KI2, bilaterally) on their lower legs. After insertion, the needles will be stimulated at 2-4Hz, 10s at each point (1min total), immediately after insertion, 5min, 10min, 15min and just before removal. After which the needles will be removed. Receives: Other: Acupuncture |
| Sham Acupuncture | Sham comparator | Specially designed Sham acupuncture needles that are not actually penetrate the skin and activate the acupoint will be used in an identical procedure to RA. The patient would be able to feel light pressure at the site. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrovascular Conductance Index
Middle Cerebral Artery Blood Velocity relative to Mean Arterial Pressure (MCABV/MAP)
Measured: 5 min of moderate exercise
Middle cerebral artery blood velocity
Velocity of blood through the middle cerebral arteries
Measured: 5 min of moderate exercise
Mean Arterial Pressure
Integral of blood pressure waveform
Measured: 5 min of moderate exercise
Secondary outcomes (9)
Heart Rate Variability
measure of the variation in time between each heartbeat
Measured: before and after acupuncture
End-tidal CO2
Partial pressure carbon dioxide (CO2) at the end of an exhaled breath
Measured: 5 min of moderate exercise
Oxygen Uptake
Volume of oxygen consumed by the body per minute
Measured: 5 min of moderate exercise
peripheral capillary oxygen saturation
estimate of the amount of oxygen in the blood
Measured: 5 min of moderate exercise
Tissue saturation index
estimate of the amount of oxygen in muscle
Measured: 5 min of moderate exercise
blood glucose levels
venous blood content
Measured: prior to enrollment
blood triglyceride levels
venous blood content
Measured: prior to enrollment
blood high density lipoprotein levels
venous blood content
Measured: prior to enrollment
blood low density lipoprotein levels
venous blood content
Measured: prior to enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start9 May 2020
- Primary completion5 Dec 2022
- Study completion5 Dec 2022
Why it stopped: Never initiated - KSP lost interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Real Acupuncture(RA): In a supine position with a cardboard blocking view of their legs, patients will have six, 0.25\*40mm sterilized stainless steel acupuncture needles (Dongbang Acupuncture, Inc., Seoul, South Korea) inserted into six acupoints (sites ST36, LV3, KI2, bilaterally) on their lower legs. After insertion, the needles will be stimulated at 2-4Hz, 10s at each point (1min total), immediately after insertion, 5min, 10min, 15min and just before removal. After which the needles will be removed. Placebo (PL): Specially designed Sham acupuncture needles that are not actually penetrate the skin and activate the acupoint will be used in an identical procedure to RA. The patient would be able to feel light pressure at the site.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy M Kellawan, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346511
- Sponsor's protocol ID
- 11943
- Acronym
- Amp-HTN
- Status last verified
- Nov 2023
- First submitted
- 10 Apr 2020
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anti-Hypertensive Acupuncture Treatment on Cerebral Blood Flow Responses to Exercise in Hypertensive Humans
- ClinicalTrials.gov ID
- NCT04346511
- Acronym / sponsor ID
- Amp-HTN / 11943
- Conditions
- High Blood Pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never initiated - KSP lost interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 9 May 2020 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 15 Apr 2020 (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.
Cerebrovascular diseases (CVD) and neurodegenerative diseases (NDD) are both leading causes of death in the United States. Epidemiological data have shown that increased prevalence of hypertension is related to these outcomes. However, despite the strong association of poor brain health outcomes in patients with hypertension (HTN), the understanding of cerebral blood flow (CBF) regulation and treatment options for HTN remain limited. Acupuncture treatment (AT), which is considered a promising complementary and integrative modality, has been known to reduce blood pressure and improve endothelial function in HTN. However, very few studies have investigated AT's effect on cerebrovascular function and the possible neuroprotective properties directly via regulating HTN. Exercise is used as a stimulus that increases the brain's metabolism and requires cerebrovascular responses (vasodilation) to meet the new metabolism.
Therefore, the specific aim of this study is to test the hypothesis that an antihypertensive acupuncture treatment can acutely improve cerebrovascular responses in hypertensive humans during moderate exercise.
Detailed description
After IRB approval, experiments will take place in the Human Circulation Research Laboratory in the Department of Health and Exercise on the OU Norman campus. All subjects will complete a total of 3 visits. The first is a screening visit to provide informed consent and to ensure the potential participant meets all inclusion criteria and no exclusion criteria. Once enrolled, participants will complete two experimental trials (Placebo (PL, Sham Acupuncture) or Real Acupuncture (RA), randomized) in a single-blinded crossover design. PL or RA treatment will precede testing by ~25min before to maximize acute responses. Test begins with 5 min of quiet rest where baseline measurements are taken, followed by 5 min of exercise. After exercise, subjects will be given 5 min of quiet rest.
Visit 1 (Screening day): ~1.5 hours. The screening visit will include informed consent, health history, physical activity questionnaires and blood sample. If qualified, the subject will be enrolled in the study and they will complete a maximal oxygen uptake (VO2max) cycle ergometer test to determine fitness.
Visit 2 \& 3 (Study day): ~1.5 hours. Instrumentation: Subjects will be equipped with ECG for heart rate (HR), photoplethysmography for blood pressure, pulse oximeter, mouthpiece for end-tidal CO2 (PETCO2) and oxygen uptake (VO2), near-infrared spectroscopy (NIRS) for active muscle oxygenation and Transcranial Doppler (TCD) for CBF. Real Acupuncture (RA): Subjects will receive ~20 minutes of RA treatment prior to exercise. Placebo (PL): Specially designed Sham Acupuncture needles will be used in the same acupoints, for the same duration as RA.
All subjects will complete a total of 3 visits separated by a minimum of 48 hours. Each study visit will take ~1.5 hours. The investigators anticipate ~ 6 hours or less of total involvement of the participants' time.
This study is a single-blind crossover design. Participants will be blinded in two trials. Practitioners and operators will not be allowed to communicate with the participants concerning the type of acupuncture devices. Outcome assessors and statisticians may not be blinded to treatment allocation.
The key dependent variable of interest is change (delta) in cerebrovascular conductance index (CVCi = CBF/blood pressure) from rest to exercise (delta CVCi = CVCiExercise - CVCiRest). Delta CVCi is the most common assessment of vasodilation in humans as it normalizes differences in blood flow to differences in blood pressure. CVCi calculates how much blood flow is observed for a given pressure. A change in CVCi (delta CVCi) has a predictable relationship where + delta CVCi indicates vasodilation (more flow for a given pressure) and - delta CVCi indicates vasoconstriction (less flow for a given pressure). Data will be analyzed using a general linear model approach (similar to ANOVA). Based on pilot data, a total sample size of 40 (20 CON and 20 HTN) will provide a power of 0.9. A minimum of 60 participants will be to recruited to ensure statistical power is achieved.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Real Acupuncture(RA): In a supine position with a cardboard blocking view of their legs, patients will have six, 0.25*40mm sterilized stainless steel acupuncture needles (Dongbang Acupuncture, Inc., Seoul, South Korea) inserted into six acupoints (sites ST36, LV3, KI2, bilaterally) on their lower legs. After insertion, the needles will be stimulated at 2-4Hz, 10s at each point (1min total), immediately after insertion, 5min, 10min, 15min and just before removal. After which the needles will be removed. Placebo (PL): Specially designed Sham acupuncture needles that are not actually penetrate the skin and activate the acupoint will be used in an identical procedure to RA. The patient would be able to feel light pressure at the site.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: AcupunctureIn a supine position with a cardboard blocking view of their legs, patients will have six, 0.25*40mm sterilized stainless steel acupuncture needles (Dongbang Acupuncture, Inc., Seoul, South Korea) inserted into six acupoints (sites ST36, LV3, KI2, bilaterally) on their lower legs. After insertion, the needles will be stimulated at 2-4Hz, 10s at each point (1min total), immediately after insertion, 5min, 10min, 15min and just before removal. After which the needles will be removed. |
| Sham Acupuncture | Sham comparator | Other: AcupunctureSpecially designed Sham acupuncture needles that are not actually penetrate the skin and activate the acupoint will be used in an identical procedure to RA. The patient would be able to feel light pressure at the site. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects will include healthy controls (CON) and Hypertension (HTN) patients between 18-65 years of age. Female participants if premenopausal will be studied in the early follicular phase of their cycle to minimize vascular effects of circulating hormones.
- 1) Stage 1 hypertensive, Systolic BP (SBP) ≥ 130 mmHg and/or Diastolic BP (DBP) > 80 mmHg, and/or diagnosis of HTN, with BMI and physical activity levels ≈ CON
- If they are on anti-hypertensive medication, the dose, type, and frequency of use will be recorded.
- HTN with an SBP > 139 mmHg must have a medical doctor's permission to participate
- CON: will be age, BMI, menstrual status for females, and physical activity matched to HTN. They must be:
Key exclusion criteria (10 listed)
- Diabetes
- Coronary artery disease
- Stroke
- Heart attack
- Sleep apnea
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 |
|---|---|---|
| AcupunctureAlso: Sham AcupuncturePatients will have six, 0.25*40mm sterilized stainless steel acupuncture needles (Dongbang Acupuncture, Inc., Seoul, South Korea) inserted into six acupoints (sites ST36, LV3, KI2, bilaterally) on their lower legs. After insertion, the needles will be stimulated at 2-4Hz, 10s at each point (1min total), immediately after insertion, 5min, 10min, 15min and just before removal. | Other | Acupuncture, Sham Acupuncture |
Primary outcome
Cerebrovascular Conductance Index
Time frame: 5 min of moderate exercise
Middle Cerebral Artery Blood Velocity relative to Mean Arterial Pressure (MCABV/MAP)
Middle cerebral artery blood velocity
Time frame: 5 min of moderate exercise
Velocity of blood through the middle cerebral arteries
Mean Arterial Pressure
Time frame: 5 min of moderate exercise
Integral of blood pressure waveform
9 secondary outcomes
Heart Rate Variability
Time frame: before and after acupuncture
End-tidal CO2
Time frame: 5 min of moderate exercise
Oxygen Uptake
Time frame: 5 min of moderate exercise
peripheral capillary oxygen saturation
Time frame: 5 min of moderate exercise
Tissue saturation index
Time frame: 5 min of moderate exercise
blood glucose levels
Time frame: prior to enrollment
blood triglyceride levels
Time frame: prior to enrollment
blood high density lipoprotein levels
Time frame: prior to enrollment
blood low density lipoprotein levels
Time frame: prior to enrolment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No. No: There is not a plan to make IPD available.
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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. This study is not recruiting at the moment.
Jeremy M Kellawan, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture in people with High Blood Pressure, run by University of Oklahoma 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 8 inclusion and 10 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: withdrawn, as of the sponsor's last update on 30 Nov 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrovascular Conductance Index (time frame: 5 min of moderate exercise). The study lists 3 primary outcomes in all. 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 30 Nov 2023.