Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000780550
Ethics application status
Approved
Date submitted
6/07/2015
Date registered
28/07/2015
Date last updated
4/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a sound wave vibration intervention on heart rate and blood pressure.
Scientific title
Effect of a sound wave vibration intervention on heart rate and blood pressure after triggering the sympathetic nervous system in healthy controls, healthy participants with elevated sympathetic activity and participants with early to mild hypertension.
Secondary ID [1] 287046 0
Nil
Universal Trial Number (UTN)
U1111-1171-9027
Trial acronym
VIVA-SNS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension mechanisms 295520 0
Sympathetic Nervous System Activity 295577 0
Condition category
Condition code
Cardiovascular 295793 295793 0 0
Normal development and function of the cardiovascular system
Neurological 295852 295852 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Sympara Therapeutic System (STS) device is a non invasive device worn as a necklace across the front of the neck with adherent pads to both clavicles which delivers therapeutic acoustic energy (sound waves). These sound waves are conducted via the clavicle to the nerves in the neck, shoulders, and armpit. We are investigating whether this device will decrease blood pressure and heart rate.

The acoustic parameters of the sound waves/vibrations are proprietary and therefore amplitude, frequency and modulation are unknown to the investigators.

The testing protocol consists of the subjects undergoing standardized autonomic reflex testing in order to evaluate the sympathetic and cardiovagal function. All experiments will be conducted in a dimly lit thermoneutral laboratory (22 degree -25 degree Centigrade). Prior to any testing, subjects will be connected to a 3-lead ECG to monitor HR, a finger blood pressure cuff and a pneumotrace to monitor respiratory movement continuous throughout the testing protocol. Subjects will perform a Valsalva maneuver, static handgrip test and cold pressor test at baseline (following 10 min of rest in a supine position). The STS device will then be applied to the subject for approximately 120 minutes, during the last 20 minutes of which the subject will repeat the testing protocol. The STS device will then be removed and the subject will rest in a supine position for an additional 20 minutes, followed by a final round of the testing protocol. Between the testing procedures (approximately 100 minutes) subjects will remain in a relaxed reclined position in the testing room.

Descriptions of the tests are below:
1. Valsalva Maneuver: Subjects will be asked to forcefully exhale with an open glottis into a mouthpiece connected to the mercury column of a sphygmomanometer with an air leak. A 40-50 mmHg pressure is maintained for 15 seconds.
2. Static Handgrip Test: Subjects will be asked to squeeze a hand dynamometer with their maximal force. The highest force attained from three attempts will be considered the subject’s maximum voluntary contraction (MVC). The subjects will perform the static handgrip test by squeezing the hand dynamometer at 30% of MVC in a sustained manner for 3 min. The subject will be instructed to avoid inadvertent Valsalva maneuvers and to maintain normal breathing patterns during this test.
3. Cold Pressor Test: Subjects will submerge their entire hand (up to the wrist) in ice-cold water for 1 min. The temperature of the water will be maintained at approximately 0–1 degrees C. The subject will be instructed to avoid inadvertent Valsalva maneuvers and to maintain normal breathing patterns during this test.

The testing protocol will take approximately four hours to complete. Subjects will be exited from the study following the completion of the testing protocol.

The test will be performed in the order Valsalva, Hand grip then cold pressor. In the control group an identical procedure will be employed without the device activated. All testing will be supervised by specific research scientists with medical backup if required. The protocol will be identical in the three specified groups, namely healthy controls, healthy individuals with known elevated sympathetic activity and otherwise healthy individuals with early to mild hypertension.
Intervention code [1] 292267 0
Other interventions
Comparator / control treatment
Sympathetic Testing Protocol that will be conducted during the testing visit:
1. Valsalva Maneuver
2. Hand Grip Test
3. Cold Pressor Test

The sham treatment procedure is identical to the active protocol saving that the device is turned off. Placebo groups will be included in all 3 pre-defined participant groups.
Control group
Placebo

Outcomes
Primary outcome [1] 295491 0
Changes in blood pressure by continuous non-invasive monitoring using the commercially available Finapres equipment.
Timepoint [1] 295491 0
Prior to any testing, subjects will undergo baseline assessment.

The STS device will be applied to the subject for ~120 minutes, during the last 20 minutes of which the subject will repeat the testing protocol. The STS device will then be turned off and the subject will rest in a supine position for an additional 20 minutes, followed by a final round of the testing protocol.
Secondary outcome [1] 315702 0
Change in heart rate using the commercially available Finapres monitor and from the continuously recorded ECG.
Timepoint [1] 315702 0
Prior to any testing, subjects will undergo baseline assessment.

The STS device will be applied to the subject for ~120 minutes, during the last 20 minutes of which the subject will repeat the testing protocol. The STS device will then be turned off and the subject will rest in a supine position for an additional 20 minutes, followed by a final round of the testing protocol.

Eligibility
Key inclusion criteria
1. Between the ages of 18 and 50 years
2. Competent and willing to provide written, informed consent to participate in the study

Normal, healthy controls:
1. Free of any comorbidities

Healthy with elevated sympathetic activity:
1. Free of any comorbidities
2. Naturally high resting heart rate
3. May have previously been diagnosed with an anxiety disorder

Early to mild hypertension:
1. Documented diagnosis and treatment of hypertension within the last six months
2. Hypertension controlled by diet and exercise or no more than one anti-hypertensive medication
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Previous renal denervation or carotid barostimulation implant
2. History of a clavicle fracture as an adult (over 18 years)
3. Haemodynamically significant valvular heart disease for which, in the opinion of the Investigator, a significant reduction of BP is contraindicated
4.History of an implanted cardiac (e.g., implantable cardioverter-defibrillator, pacemaker, cardiac resynchronisation therapy) or neurostimulation device
5. History of having undergone any type of cardiac surgery including coronary artery bypass graft and/or valve surgery
6. History of stent grafting
7. Known secondary causes of hypertension or primary pulmonary hypertension
8. Prior surgery or radiation to the area of the carotid sinus, or presence of a stent or other implant in the carotid artery
9. Known or suspected baroreflex failure or significant orthostatic hypotension (one or more episodes in the past year not related to medications. Defined as reduction in SBP of equal to or more than 20mmHg or diastolic blood pressure (DBP) equal to or more than 10 mmHg within three minutes of standing).
10. One or more hospital admissions for a hypertensive crisis within the past year. Hypertensive crisis is defined as severely elevated BP [greater than 180/110 mmHg] that is not related to confirmed non-adherence with medications, together with progressive or impending target organ damage, requiring hospitalization and typically admission to the intensive care unit
11. History of a myocardial infarction, unstable angina, or documented multi-vessel coronary artery disease
12. History of syncope, transient ischemic attack and/or cerebral vascular accident within the last 6 months
13. Subject with atrial fibrillation, supraventricular tachycardia, or other documented sustained arrhythmias that required hospitalization within the last 6 months
14. Type 1 diabetes mellitus
15. Chronic renal disease requiring dialysis
16. Kidney or liver transplant
17. Females who are pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Three distinct groups of subjects (1. healthy controls, 2. healthy subjects with known elevated sympathetic activity and 3. subjects with early to mild HTN) will undergo a series of in-office tests intended to cause an increase in sympathetic activity (Valsalva maneuver, hand-grip test and cold presser test) with and without the STS device in order to assess the device’s effect on overall sympathetic activity.

Prospective subjects will complete a screening visit to confirm they meet all of the inclusion criteria and none of the exclusion criteria. Eligible subjects will then be enroled into the study. Subjects will then return to complete the testing protocol, which consists of repeating a series of in-office tests at baseline, with the STS device on and following cessation of STS device use. The length of study participation is approximately four to five hours.

Allocation to placebo will be via sealed opaque envelopes in the required 1 to 4 ratio pre-prepared for each group held centrally by an independent person.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomized in a 1:4 ratio to either a sham (i.e. the device does not deliver therapeutic energy) or active STS device.

Pre-prepared, opaque sealed envelopes will be shuffled by an independent person and drawn at random to allocated active/placebo at time of recruitment. This will be done for each group separately.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This prospective, acute study intends to enroll up to 50 subjects at MonashHeart to determine if acute use of the STS triggers an autonomic-mediated reflex that, in turn, results in a clinically significant reduction in blood pressure and heart rate physiological effect compared to baseline values. This is a pilot study, there is no data available to calculate required sample size. Results at the three measurement points will in the first instance be compared by analysis of variance.

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
10/08/2015
Actual
11/08/2015
Date of last participant enrolment
Anticipated
29/07/2016
Actual
21/08/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4005 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 9935 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 291603 0
Hospital
Name [1] 291603 0
Monash Health
Country [1] 291603 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Rd
Clayton Victoria 3168
Australia
Country
Australia
Secondary sponsor category [1] 290274 0
None
Name [1] 290274 0
Address [1] 290274 0
Country [1] 290274 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293133 0
Monash Health HREC
Ethics committee address [1] 293133 0
Ethics committee country [1] 293133 0
Australia
Date submitted for ethics approval [1] 293133 0
14/05/2015
Approval date [1] 293133 0
04/08/2015
Ethics approval number [1] 293133 0
15198A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58622 0
Prof Ian Meredith
Address 58622 0
MonashHeart
Monash Medical Centre
246 Clayton Rd
Clayton 3168 Victoria
Country 58622 0
Australia
Phone 58622 0
+61 3 95942726
Fax 58622 0
Email 58622 0
[email protected]
Contact person for public queries
Name 58623 0
Julie Plunkett
Address 58623 0
MonashHeart
Monash Medical Centre
246 Clayton Rd
Clayton 3168 Victoria
Country 58623 0
Australia
Phone 58623 0
+61 3 95944597
Fax 58623 0
Email 58623 0
[email protected]
Contact person for scientific queries
Name 58624 0
James Cameron
Address 58624 0
MonashHeart
Monash Medical Centre
246 Clayton Rd
Clayton 3168 Victoria
Country 58624 0
Australia
Phone 58624 0
+61 3 95944264
Fax 58624 0
Email 58624 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.