NCT01184755

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

May 16, 2017

Completed
Last Updated

May 16, 2017

Status Verified

April 1, 2017

Enrollment Period

6.2 years

First QC Date

August 17, 2010

Results QC Date

January 11, 2017

Last Update Submit

April 11, 2017

Conditions

Hypertension

Keywords

Device-guided breathinghypertensionbehavioral interventionstress reductionHeart Rate Variability (HRV) biofeedback

Outcome Measures

Primary Outcomes (1)

  • Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages)

    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.

    8 weeks

Study Arms (3)

Resperate device used for 8 weeks

EXPERIMENTAL

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

Relaxation control device

ACTIVE COMPARATOR

Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter

Behavioral: Relaxation

Usual Care

NO INTERVENTION

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.

Interventions

RelaxationBEHAVIORAL

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).

Relaxation control device
RESPeRateDEVICE
Resperate device used for 8 weeks

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Diabetes
  • Atrial Fibrillation
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Lynn Clemow, PhD
Organization
Rutgers - Robert Wood Johnson Medical School
lynn.clemow@rutgers.edu
732-235-6972

Study Officials

  • Lynn P Clemow, PhD

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 19, 2010

Study Start

May 1, 2008

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 16, 2017

Results First Posted

May 16, 2017

Record last verified: 2017-04

Locations

US(2)