BreathingPhase 1NCT02226744
Study to Measure Relaxation From Different Types of Focused Breathing Exercises
A Phase 1 study testing Focused Breathing in people with Breathing and Mind-body Practices, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Breathing, Mind-body Practices, Yoga
- What is being tested?
- Focused Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 30 to 50 years
- English speaking
Who cannot join
- Hypertension
- Heart disease: history of coronary artery disease, myocardial infarction, significant valvular disease, or congestive heart failure
- Diabetes
- Renal Disease
- Anxiety Disorder
- Depression
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Focused Breathing Study
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.
- Conditions
- Breathing, Mind-body Practices, Yoga, Meditation
- Being tested
- Focused Breathing
- Keywords
- breathing, mind-body practices, yoga, meditation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused BreathingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Focused breathing | Active comparator | Focused deep breathing techniques used to produce specific physiological and psychological states Receives: Behavioral: Focused Breathing |
| Focused breathing 2 | Active comparator | Focused deep breathing techniques used to produce specific physiological and psychological states Receives: Behavioral: Focused Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of changes in heart rate response to upright position
Measured: 10 minutes at baseline, 2 weeks and 6 weeks
Secondary outcomes (2)
Magnitude of changes in heart rate variability measured as ratio of low frequency to high frequency ratio components (Hz)
Measured: Baseline, 2 weeks, and 6 weeks
Magnitude of changes in catecholamines in response to upright position
Measured: 10 minutes at baseline, 2 weeks, and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: No funds to complete study as anticipated, preliminary data used for future grant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreathingStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gurjeet Birdee, Vanderbilt University Medical Center
- Investigators
- Gurjeet S Birdee, MD MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226744
- Sponsor's protocol ID
- 131700
- Status last verified
- Dec 2016
- First submitted
- 20 Aug 2014
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Breathing Study
- ClinicalTrials.gov ID
- NCT02226744
- Acronym / sponsor ID
- 131700
- Conditions
- Breathing, Mind-body Practices, Yoga, Meditation
- Keywords
- breathing, mind-body practices, yoga, meditation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No funds to complete study as anticipated, preliminary data used for future grant
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focused breathing | Active comparator | Behavioral: Focused BreathingFocused deep breathing techniques used to produce specific physiological and psychological states |
| Focused breathing 2 | Active comparator | Behavioral: Focused BreathingFocused deep breathing techniques used to produce specific physiological and psychological states |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 30 to 50 years
- English speaking
Key exclusion criteria (18 listed)
- Hypertension
- Heart disease: history of coronary artery disease, myocardial infarction, significant valvular disease, or congestive heart failure
- Diabetes
- Renal Disease
- Anxiety Disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused Breathing | Behavioural | Focused breathing, Focused breathing 2 |
Primary outcome
Magnitude of changes in heart rate response to upright position
Time frame: 10 minutes at baseline, 2 weeks and 6 weeks
2 secondary outcomes
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
Magnitude of changes in catecholamines in response to upright position
Time frame: 10 minutes at baseline, 2 weeks, and 6 weeks
Results and safety
The study was stopped early (reason given: No funds to complete study as anticipated, preliminary data used for future grant). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
Related trials for Breathing
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gurjeet S Birdee, MD MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Focused Breathing in people with Breathing and Mind-body Practices, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No funds to complete study as anticipated, preliminary data used for future grant). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of changes in heart rate response to upright position (time frame: 10 minutes at baseline, 2 weeks and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2017.