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Clinical Trial Summary

The purpose of this study is to better understand specific stress-management practices on mood, sleep, and physiology. Participants will be assigned to one of three interventions (they all active interventions - none are a "wait-list"). Each intervention asks participants to engage in a daily practice of 20 minutes per day for 8 weeks. Questionnaires and measures of heart rate and blood pressure will be collected at the start and end of the 8 weeks, including a virtual laboratory visit.

Clinical Trial Description

Slow-paced breathing (SPB), mindfulness (M), and their combination (SPB+M) in the form of yoga, yogic breathing, Tai Chi, Qigong, and other practices are considered distinct forms of intervention, yet are often considered inextricably linked and overlapping in their effects on the autonomic nervous system. Although the scientific community continues to build understanding of autonomic mechanisms that might be unique to SPB, M, and their interaction (SPB+M), no studies we are aware of have attempted to directly compare these three forms of intervention in a controlled fashion that enables a 'dismantling' framework of interpretation. The goal of this pilot project is to compare the separate and combined effects of SPB and M on autonomic function. We will test the feasibility of a three-arm intervention trial (N=5 per group), involving 20-min daily practice for 8 weeks, with multimodal ambulatory autonomic measurement before and after intervention. We will first focus on a healthy young adult population to then inform translation to hypertension, insomnia, and other clinical groups. Aim 1: Distinguish SPB, M, and SPB+M training in terms of breathing rate and subjective mindfulness. Aim 2: Obtain pilot data comparing the three interventions in terms of autonomic regulation using both conventional metrics and non-linear dynamics. Aim 3: Develop methods to examine relationships across domains of autonomic regulation, stress, and sleep for the three interventions. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04866901
Study type Interventional
Source Beth Israel Deaconess Medical Center
Contact Michael R Goldstein, PhD
Phone ?(617) 356-7246?
Email [email protected]
Status Recruiting
Phase N/A
Start date May 3, 2021
Completion date August 31, 2021

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