RCT of Effects of Device-guided Breathing on Ambulatory BP

Completed · Not applicable

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT01184755

Run by

Rutgers, The State University of New Jersey

People needed

253

Starts

2008-05-01

Expected to finish

2014-07-01

Last updated by the study team

2017-05-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• UMDNJ - Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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