RCT of Effects of Device-guided Breathing on Ambulatory BP (RESPeRate)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lynn P. Clemow, Ph.D., ABPP, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01184755
First received: August 17, 2010
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

Although drug therapies have greatly improved blood pressure (BP) control and reduction of cardiovascular events, as many as 50% of hypertensives on drug treatment have inadequately controlled BP due to poor adherence, insufficiently aggressive treatment, and an aversion on the part of many patients to drug treatment. Device-guided breathing is a behavioral intervention that guides the breathing into the 6 per minute range, inducing respiratory sinus arrythmia (RSA), which is the natural cycle of arrythmia that occurs through the influence of breathing on the flow of sympathetic and vagus impulses to the sinoatrial node of the heart. It has been shown in several small trials to have substantial effects on BP reduction, has no known side-effects, and may represent a cost-effective adjunctive treatment for hypertension. an important consideration is that, often, behavioral interventions are given for a brief amount of time, but are expected to have long-term effects. This does not hold true for medication; one would not give anti-hypertensive medication for eight weeks and expect an effect on BP several months later. The development of behavioral interventions needs to take into account methods to sustain long-term effects.

Our aim is to conduct a randomized controlled trial (RCT) to test the efficacy of a guided breathing intervention on ambulatory BP (ABP) in hypertensives drawn from primary care and specialty hypertension practices, using a sample size powered to detect effects at 8 weeks and 4-month follow-up. We also propose to study a physiological mechanism, baroreflex sensitivity, that may mediate the effect of the intervention on BP. The design calls for two control groups: Usual Care (UC) and a placebo condition (using a device that gives the same type of feedback sounds as the guided breathing feedback device, but modified to pace the breathing at approximately 13 breaths per minute, a normal resting rate.) There are two intervention conditions using the RESPeRate device that guides the breath into the 6 breaths/minute range. In both, the initial intervention lasts eight weeks, following which participants are further randomized to either: 1) ending the intervention; of 2) continuing the intervention for the next 8 weeks. The main outcomes are the change in systolic and diastolic BP (measured by Ambulatory BP monitoring) during the waking hours. Outcomes are measured at baseline, 8 weeks, and 16 weeks


Condition Intervention Phase
Hypertension
Behavioral: Device-guided breathing - RESPeRate device used for 8 weeks
Behavioral: Device-guided breathing - used for 16 weeks
Behavioral: Relaxation - placebo device
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: RCT of Device-guided Breathing Effects on Ambulatory BP

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Change in systolic and diastolic BP measured by Ambulatory BP monitoring (waking averages) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • systolic and diastolic BP measured by Ambulatory BP monitoring (waking averages) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: May 2008
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resperate device used for 8 weeks
Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks
Behavioral: Device-guided breathing - RESPeRate device used for 8 weeks
Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)
Experimental: RESPeRate device - used for 16 weeks
RESPeRate device to guide breathing used for all 16 weeks of study
Behavioral: Device-guided breathing - used for 16 weeks
Participants are instructed to practice breathing using the RESPeRate device daily for 15 minutes (the session is timed and recorded on device used at home)
Placebo Comparator: Relaxation placebo device
Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter
Behavioral: Relaxation - placebo device
Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).
No Intervention: Usual Care
Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Hypertension
  • Treated with at least one antihypertensive drug
  • BP still not controlled (>135/85 on ABPM waking average)

Exclusion Criteria:

  • Diabetes
  • Atrial Fibrillation
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184755

Locations
United States, New Jersey
UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Lynn P Clemow, PhD Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Lynn P. Clemow, Ph.D., ABPP, Clinical Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01184755     History of Changes
Other Study ID Numbers: 526, R01HL083056-01
Study First Received: August 17, 2010
Last Updated: June 11, 2014
Health Authority: United States: Federal Government

Keywords provided by Rutgers, The State University of New Jersey:
Device-guided breathing
hypertension
behavioral intervention
stress reduction
HRV biofeedback

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014