At a glance

ClinicalIndex Comparison Record

N/ACompleted· 253 enrolled

Drug / intervention

Relaxation +1 morebehavioral

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01184755

NCT01184755N/ACompleted

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RCT of Device-guided Breathing Effects on Ambulatory BP

Rutgers, The State University of New Jersey·interventional·Posted Aug 19, 2010·Updated May 16, 2017

In Brief

A clinical study evaluating Relaxation and RESPeRate for Hypertension. Completed, enrolled 253 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHypertension

CountriesUnited States

CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

N/ACompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2008

First PostedAug 2010

Primary CompletionJul 2014

TodayJul 2026

First PostedAug 19, 2010

Enrollment StartMay 1, 2008

Primary CompletionJul 1, 2014

TodayJul 2, 2026

Enrollment to primary: 6.2 yearsPosted 15.9 years ago

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).

RESPeRatedevice