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

August 17, 2010
June 11, 2014
May 2008
July 2014   (final data collection date for primary outcome measure)
Change in systolic and diastolic BP measured by Ambulatory BP monitoring (waking averages) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01184755 on ClinicalTrials.gov Archive Site
systolic and diastolic BP measured by Ambulatory BP monitoring (waking averages) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
RCT of Effects of Device-guided Breathing on Ambulatory BP
RCT of Device-guided Breathing Effects on Ambulatory BP

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hypertension
  • 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)
  • 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)
  • 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).
  • 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
    Intervention: Behavioral: Device-guided breathing - RESPeRate device used for 8 weeks
  • Experimental: RESPeRate device - used for 16 weeks
    RESPeRate device to guide breathing used for all 16 weeks of study
    Intervention: Behavioral: Device-guided breathing - used for 16 weeks
  • 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
    Intervention: Behavioral: Relaxation - placebo 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01184755
526, R01HL083056-01
Yes
Lynn P. Clemow, Ph.D., ABPP, Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Lynn P Clemow, PhD Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP