A New Translational Tool for Studying the Role of Breathing in Meditation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01264627
Recruitment Status : Active, not recruiting
First Posted : December 22, 2010
Last Update Posted : October 26, 2016
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
A recent National Health Interview Survey reported that breathing exercises were the second most common complementary and alternative medicine practice in the United States, following only the use of "natural products." With such widespread interest in breathing exercises, alone or as a component of practices such as meditation, a need exists for research that examines not only its efficacy, but also investigates potential mechanisms of action. Indeed, a recent National Center for Complementary and Alternative Medicine (NCCAM) Meditation Workshop recommended research to clarify biological pathways by which meditation practices, including breathing exercises, can impact health. To explore mechanisms underlying the health effects of breathing exercises, new translational tools are needed that can measure breathing patterns in both the clinic and natural environment. The primary objective of the present proposal is the application of a new technology to the investigation of pathways by which breathing exercises can affect health. For this project, the health-related outcome measure to be studied is a major cardiovascular risk factor, blood pressure.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Mindful Breathing (MB) Intervention Behavioral: Usual Care (UC) Control Condition Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Project Inspire: A New Translational Tool for Studying the Role of Breathing in Meditation
Study Start Date : February 2011
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Experimental: Mindful Breathing (MB) Behavioral: Mindful Breathing (MB) Intervention
The MB intervention is based off of the Mindfulness Based Stress Reduction Program developed by Jon Kabat-Zinn. Participants will be organized into cohorts of eight, and attend eight weekly MB sessions. Mindful breathing consists of closely "following the breath," throughout inhalation and exhalation, sustaining moment-to-moment awareness on the breathing process, and passively observing thoughts, affective states, perceptions and events, from a non-evaluative, non-judgmental perspective. As attention wanders to concerns, thoughts, events or ideas, the participants will be instructed to acknowledge and accept these without evaluation and return the focus of attention back to breathing. Participants in MB will have their breathing rate and PetCO2 monitored during the eight training sessions with individual ambulatory breathing monitors.
Usual Care (UC) Behavioral: Usual Care (UC) Control Condition
This control intervention is designed to account for the effects of nonspecific factors such as enrollment in a study to enhance health with the associated expectancy effects, staff attention, and measurement procedures including the monitoring of PetCO2 and BP, and completion of questionnaires. Participants who are randomly assigned to the Usual Care condition will receive care as usual for the management of their prehypertensive condition. UC participants will receive their usual care and have access to all Kaiser Permanente (KP) health education resources, such as KP's interactive healthcare guide, and online "Healthy Lifestyle Programs". We will assess the extent to which participants in both MB and UC used these resources.

Primary Outcome Measures :
  1. Blood Pressure [ Time Frame: Up to Week 25 ]
    Measured using Ambulatory, 24-Hr BP monitor

Secondary Outcome Measures :
  1. Clinic (resting) blood pressure [ Time Frame: Up to Week 25 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Mean 24-hr SBP: 130-139 mmHg
  • Female
  • > 50 years of age
  • Post menopausal, defined as greater than or equal to one year without a menstrual cycle.
  • Body Mass Index (BMI): 19-31
  • English speaking (Patients not able to read and speak English will be excluded as the behavioral group interventions are conducted in English)
  • Has a personal physician

Exclusion Criteria (Individuals will be filtered in the KP OSCA database according to the following ICD-9 codes):


  • 491.X chronic Bronchitis incl COPD
  • 492.X emphysema
  • 493.X asthma
  • 494-496; 500-519: all kinds of chronic pulmonary conditions


  • 404.9 chronic ischemic heart disease
  • 425.X cardiomyopathies
  • 428.X heart failure
  • 430-438 cerebrovascular diseases


  • 582-583 chronic glomerulonephritis
  • 584-588 renal failure


- 571.X chronic liver disease and cirrhosis Smoker: 305.1


  • 290-299 dementia/schizophrenia/ psychoses…
  • 303, 304 alcohol or drug dependence
  • 317-319 mental retardation


  • All blood pressure medications
  • All tranquilizers, benzodiazepins if prescribed regularly, e.g. every month
  • All narcotics if prescribed regularly, e.g. every month


- Plan to relocate residence outside recruitment area during the intervention or follow- period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01264627

Sponsors and Collaborators
University of California, San Francisco
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Margaret A Chesney, PhD University of California, San Francisco

Responsible Party: University of California, San Francisco Identifier: NCT01264627     History of Changes
Other Study ID Numbers: 1R01AT005820 ( U.S. NIH Grant/Contract )
First Posted: December 22, 2010    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by University of California, San Francisco:
Blood pressure

Additional relevant MeSH terms:
Respiratory Aspiration
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes