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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
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: April 11, 2017
Last verified: April 2017
  Purpose
Our aim is to conduct a randomized controlled trial (RCT) to test the efficacy of a guided breathing intervention on ambulatory blood pressure (ABP), both systolic and diastolic BP. There are 3 groups: 1) Intervention group instructed to use the RESPeRate device that guides the breath into the 6 breaths/minute range daily for 8 weeks. 2) Relaxation control condition (using a modified device to guide breathing at 13 breaths/minute rate); and 3) Usual Care (UC). After the initial 8 week trial, the main outcome, the intervention group will be randomly assigned to stop using the RESPeRate device or to continue using it for 8 more weeks.

Condition Intervention
Hypertension Behavioral: Relaxation Device: RESPeRate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: RCT of Device-guided Breathing Effects on Ambulatory BP

Further study details as provided by Lynn P. Clemow, Ph.D., ABPP, 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 ]
    The primary outcome for this study is the change in systolic and diastolic BP measured by Ambulatory BP monitoring at 8-weeks. The measure is the waking mean BP.


Enrollment: 253
Study Start Date: May 2008
Study Completion Date: July 2014
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. After the primary 8-week trial, this group is divided into two subgroups to examine 16-week data: one subgroup that stops using the device after 8 weeks, and one asked to continue to use the device for the full 16 weeks.
Device: RESPeRate
Active Comparator: Relaxation control 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
Participants are instructed to use the modified 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.

Detailed Description:

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. The design calls for two control groups: Usual Care (UC) and a relaxation control 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.) The intervention condition has participants use the RESPeRate device that guides the breath into the 6 breaths/minute range. 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 at 8 weeks in systolic and diastolic BP (measured by Ambulatory BP monitoring) during the waking hours. Outcomes are measured at baseline, 8 weeks, and 16 weeks. The primary outcomes are BP results at 8 weeks, with a 3-group comparison of the intervention group, the relaxation control group and usual care.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Hypertension
  • Treated with at least one antihypertensive drug
  • BP still not controlled (>135/85 on Ambulatory BP 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
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Lynn P Clemow, PhD Rutgers, The State University of New Jersey
  More Information

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 ( US NIH Grant/Contract Award Number )
Study First Received: August 17, 2010
Results First Received: January 11, 2017
Last Updated: April 11, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Lynn P. Clemow, Ph.D., ABPP, Rutgers, The State University of New Jersey:
Device-guided breathing
hypertension
behavioral intervention
stress reduction
Heart Rate Variability (HRV) biofeedback

Additional relevant MeSH terms:
Hypertension
Respiratory Aspiration
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 26, 2017