This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
August 17, 2010
April 11, 2017
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 ]
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.
Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages) [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT01184755 on ClinicalTrials.gov Archive Site
Not Provided
systolic and diastolic BP measured by Ambulatory BP monitoring (waking averages) [ Time Frame: 16 weeks ]
Not Provided
Not Provided
 
RCT of Effects of Device-guided Breathing on Ambulatory BP
RCT of Device-guided Breathing Effects on Ambulatory BP
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Hypertension
  • 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).
  • Device: RESPeRate
  • 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.
    Intervention: 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
    Intervention: Behavioral: Relaxation
  • 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.
 
Completed
253
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 Ambulatory BP waking average)

Exclusion Criteria:

  • Diabetes
  • Atrial Fibrillation
  • Pregnancy
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01184755
526
R01HL083056-01 ( US NIH Grant/Contract Award Number )
Yes
Not Provided
Undecided
Not Provided
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
April 2017

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