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TerminatedNCT02226744Updated Jan 2, 2017

Study to Measure Relaxation From Different Types of Focused Breathing Exercises

A Phase 1 interventional study of Focused Breathing in Breathing, Mind-body Practices and Yoga, sponsored by Vanderbilt University Medical Center. Terminated at 1 site in United States. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-02.

Sponsored by Vanderbilt University Medical Center · Phase 1, Interventional, and Treatment

Why this study was terminated
No funds to complete study as anticipated, preliminary data used for future grant
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Study summary

Mind-body practices, such as yoga, ta'i chi, mindfulness and biofeedback, commonly use slow breathing techniques to induce physiological and mental relaxation. Medical research suggests that slow breathing techniques induce physiological relaxation. This 6 week study will compare the effects of different types of breathing. The hypothesis is that different breathing techniques produce different physiological and mental changes.

02

Conditions studied

  • Breathing
  • Mind-body Practices
  • Yoga
  • Meditation

Keywords

  • breathing
  • mind-body practices
  • yoga
  • meditation
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's enrollment of 24 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.

Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 30 to 50 years
  • English speaking

Exclusion criteria

Exclusion Criteria:

  • Hypertension
  • Heart disease: history of coronary artery disease, myocardial infarction, significant valvular disease, or congestive heart failure
  • Diabetes
  • Renal Disease
  • Anxiety Disorder
  • Depression
  • Other psychiatric conditions including schizophrenia or bipolar disorder
  • Attention-deficit-disorder or Attention-deficit-hyperactivity disorder
  • Musculoskeletal condition limiting capacity to perform yoga such as chronic lower back pain, chronic neck pain
  • Asthma
  • Chronic Obstructive Lung Disease
  • Obstructive Sleep Apnea
  • Smoker
  • Currently taking blood pressure medications, oral diabetic medication or insulin
  • Current participation in a mind-body practice/program
  • Current cancer other than non-melanoma skin cancer
  • Regular swimmer
  • Plays wind or brass musical instruments
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    Focused breathing

    Focused deep breathing techniques used to produce specific physiological and psychological states

    Behavioral: Focused Breathing

  • Active comparator
    Focused breathing 2

    Focused deep breathing techniques used to produce specific physiological and psychological states

    Behavioral: Focused Breathing

Interventions

  • BehavioralFocused Breathing
06

What researchers measure

Primary outcomes

  1. Magnitude of changes in heart rate response to upright position

    Time frame: 10 minutes at baseline, 2 weeks and 6 weeks

Secondary outcomes

  1. Magnitude of changes in heart rate variability measured as ratio of low frequency to high frequency ratio components (Hz)

    Time frame: Baseline, 2 weeks, and 6 weeks

  2. Magnitude of changes in catecholamines in response to upright position

    Time frame: 10 minutes at baseline, 2 weeks, and 6 weeks

07

Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02226744
Lead sponsor
Vanderbilt University Medical Center
Responsible party
Gurjeet Birdee (Assistant Professor, Vanderbilt University Medical Center) — Principal investigator
First posted
Aug 27, 2014
Start date
Aug 2014
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Jan 2, 2017

Study contacts

Gurjeet S Birdee, MD MPH
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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