HypertensionPhase 4NCT01390727
Effects of Slow Breathing on Blood Pressure and Autonomic Function
A Phase 4 study testing Device-guided breathing (Resperate - InterCure, Israel) and Listen music in people with Hypertension, run by Fundação de Amparo à Pesquisa do Estado de São Paulo at 1 site in Brazil.
Trial summary
Hypertension is a chronic disease that affects about 23% of the brazilian population. The treatment of hypertension by pharmacological intervention is efficacious, but has side effects and significant costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Device-guided breathing (Resperate - InterCure, Israel) and Listen music
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Dec 2014
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertensive patients with or without use of antihypertensive drug therapy with office systolic blood pressure between 140 and 179 mmHg and / or office diastolic between 90 and 109mmHg).
- Adults over 18 years.
- Both genders.
Who cannot join
- Use of medications that alter sympathetic nerve activity (beta blockers and / or sympatholytics).
- Use of three or more classes of antihypertensive drugs
- Secondary Hypertension
- Chronic Respiratory Disease
- Diabetes Mellitus.
- Chronic Kidney Disease with Clearance Creatinine <60 ml/min
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- Congestive heart failure
- Coronary disease
- Pregnant
- BMI > 30 kg/m2
Trial locations and contacts
1 site in 1 country.
Brazil1 site
General Hospital of School of Medicine - Universiy of Sao Paulo
São Paulo, São Paulo, 05403-000
About this study
Official title: Effects of Slow Breathing on Blood Pressure and Autonomic Function in Hypertensive Patients
Hypertension is a chronic disease that affects about 23% of the brazilian population. The treatment of hypertension by pharmacological intervention is efficacious, but has side effects and significant costs. Techniques that reduce the respiratory rate are shown as a effective non-pharmacological treatment in controlling blood pressure. Evidence has shown that a slow and deep breathing rate, around 10 breaths per minute or less, significantly reduces blood pressure. However, the physiological mechanisms involved in blood pressure decrease due to decreased respiratory rate are not yet known. Therefore the goals of this study will evaluate the chronic effect of breathing exercise guided on office and 24 hours blood pressure and analyse the chronic effect of breathing exercise guided over the autonomic function in hypertensive patients in stages 1 and 2.
- Conditions
- Hypertension
- Being tested
- Device-guided breathing (Resperate - InterCure, Israel), Listen music
- Keywords
- hypertension, device-guided breathing, autonomic function, Resperate
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device-guided breathing (Resperate - InterCure, Israel)Device
After randomization, the patients allocated in this arm will be instructed to use a device-guided breathing, for 15 minutes per day during 8 weeks, with the aim to reduce the respiratory frequency to less than 10 breaths/min
Listen musicOther
After randomization, the patients allocated in this arm will be instructed to listen to calm music for 15 minutes per day during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Listen music | Placebo comparator | After randomization, the patients allocated in this arm will be instructed to listen to calm music for 15 minutes per day during 8 weeks Receives: Other: Listen music |
| Device-guided breathing | Active comparator | After randomization, the patients allocated in this arm will be instructed to use a device-guided breathing, for 15 minutes per day during 8 weeks, with the aim to reduce the respiratory frequency to less than 10 breaths/min Receives: Device: Device-guided breathing (Resperate - InterCure, Israel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure reduction
The blood pressure reduction in mmHg will be verified by office blood pressure measurement and ambulatory blood pressure monitoring (ABPM)
Measured: 8 weeks after the randomization
Secondary outcomes (1)
autonomic regulation
The autonomic function will be verified in the beginning and after 8 weeks from randomization as follows: muscle sympathetic nervous activity (MSNA) by microneurography technique (burst/min), plasma catecholamines levels (pg/ml) and heart rate variability by power spectral analysis (ms).
Measured: 8 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Decio Mion Jr., University of Sao Paulo General Hospital
- Investigators
- Decio Mion Junior, MD, Study chair, General Hospital of School of Medicine - University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390727
- Sponsor's protocol ID
- FAPESP 2010/06921-2
- Status last verified
- May 2016
- First submitted
- 23 May 2011
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
de Barros S, da Silva GV, de Gusmao JL, de Araujo TG, de Souza DR, Cardoso CG Jr, Oneda B, Mion D Jr. Effects of long term device-guided slow breathing on sympathetic nervous activity in hypertensive patients: a randomized open-label clinical trial. Blood Press. 2017 Dec;26(6):359-365. doi: 10.1080/08037051.2017.1357109. Epub 2017 Jul 20.
PubMed 28724309
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Slow Breathing on Blood Pressure and Autonomic Function in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT01390727
- Acronym / sponsor ID
- FAPESP 2010/06921-2
- Conditions
- Hypertension
- Keywords
- hypertension, device-guided breathing, autonomic function, Resperate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fundação de Amparo à Pesquisa do Estado de São PauloOther government
- Study start
- May 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Jul 2011 (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.
Hypertension is a chronic disease that affects about 23% of the brazilian population. The treatment of hypertension by pharmacological intervention is efficacious, but has side effects and significant costs. Techniques that reduce the respiratory rate are shown as a effective non-pharmacological treatment in controlling blood pressure. Evidence has shown that a slow and deep breathing rate, around 10 breaths per minute or less, significantly reduces blood pressure. However, the physiological mechanisms involved in blood pressure decrease due to decreased respiratory rate are not yet known. Therefore the goals of this study will evaluate the chronic effect of breathing exercise guided on office and 24 hours blood pressure and analyse the chronic effect of breathing exercise guided over the autonomic function in hypertensive patients in stages 1 and 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Listen music | Placebo comparator | Other: Listen musicAfter randomization, the patients allocated in this arm will be instructed to listen to calm music for 15 minutes per day during 8 weeks |
| Device-guided breathing | Active comparator | Device: Device-guided breathing (Resperate - InterCure, Israel)After randomization, the patients allocated in this arm will be instructed to use a device-guided breathing, for 15 minutes per day during 8 weeks, with the aim to reduce the respiratory frequency to less than 10 breaths/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hypertensive patients with or without use of antihypertensive drug therapy with office systolic blood pressure between 140 and 179 mmHg and / or office diastolic between 90 and 109mmHg).
- Adults over 18 years.
- Both genders.
Key exclusion criteria (10 listed)
- Use of medications that alter sympathetic nerve activity (beta blockers and / or sympatholytics).
- Use of three or more classes of antihypertensive drugs
- Secondary Hypertension
- Chronic Respiratory Disease
- Diabetes Mellitus.
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 |
|---|---|---|
| Device-guided breathing (Resperate - InterCure, Israel)After randomization, the patients allocated in this arm will be instructed to use a device-guided breathing, for 15 minutes per day during 8 weeks, with the aim to reduce the respiratory frequency to less than 10 breaths/min | Device | Device-guided breathing |
| Listen musicAfter randomization, the patients allocated in this arm will be instructed to listen to calm music for 15 minutes per day during 8 weeks | Other | Listen music |
Primary outcome
blood pressure reduction
Time frame: 8 weeks after the randomization
The blood pressure reduction in mmHg will be verified by office blood pressure measurement and ambulatory blood pressure monitoring (ABPM)
1 secondary outcome
autonomic regulation
Time frame: 8 weeks after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Derived from this study: PubMed 28724309de Barros S, da Silva GV, de Gusmao JL, de Araujo TG, de Souza DR, Cardoso CG Jr, Oneda B, Mion D Jr. Effects of long term device-guided slow breathing on sympathetic nervous activity in hypertensive patients: a randomized open-label clinical trial. Blood Press. 2017 Dec;26(6):359-365. doi: 10.1080/08037051.2017.1357109. Epub 2017 Jul 20.
- Individual participant dataSharing planned: No
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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.
Decio Mion Junior, MD study chair
General Hospital of School of Medicine - University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Device-guided breathing (Resperate - InterCure, Israel) and Listen music in people with Hypertension, run by Fundação de Amparo à Pesquisa do Estado de São Paulo at 1 site in Brazil.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 9 May 2016. 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 Brazil. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
blood pressure reduction (time frame: 8 weeks after the randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01390727, which also lists 1 linked publication.
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 9 May 2016.