Efficacy of a sound wave vibration intervention on heart rate and blood pressure.

Not Applicable

• Conditions: Hypertension mechanisms; Sympathetic Nervous System Activity; Cardiovascular - Normal development and function of the cardiovascular system; Neurological - Studies of the normal brain and nervous system

• Registration Number: ACTRN12615000780550
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 50

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

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

• Study Type: Interventional
• Study Design: Not specified