RCT of Effects of Device-guided Breathing on Ambulatory BP
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

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.
    

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.
    

Intervention name(s): Relaxation; RESPeRate
Intervention type(s): Behavioral; Device
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Device-guided breathing; hypertension; behavioral intervention; stress reduction; Heart Rate Variability (HRV) biofeedback