AnxietyNCT02828072
Sudarshan Kriya Yoga and Cardiac Autonomic Control in Patients With Anxiety-Depression Disorders
A study testing SKY therapy and usual drug therapy in people with Anxiety and Depression, run by University of Milan.
Trial summary
The effects of Sudarshan Kriya Yoga (SKY) on autonomic function in patients with anxiety-depression disorders is unknown. Thus, the authors will investigate cardiac autonomic control in a population of patients with anxiety-depression disorders which will undergo a specific SKY treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- SKY therapy and usual drug therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Mar 2012
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of anxiety-depression disorder
Who cannot join
- absence of sinus rhythm on ECG
- absence of any cardiovascular and metabolic disorder
About this study
Official title: Effects of Sudarshan Kriya Yoga on Cardiac Autonomic Control and Anxiety/Depression Levels in Patients Affected by Anxiety-Depression Disorders
The effects of Sudarshan Kriya Yoga (SKY) on autonomic function in patients with anxiety-depression disorders is unknown. Thus, the authors will investigate cardiac autonomic control in a population of patients with anxiety-depression disorders which will undergo a specific SKY treatment.
Read the detailed description
Several studies have demonstrated that adjuvant therapies as exercise and breathing training are effective in improving cardiac autonomic control (CAC) in patients with affective spectrum disorders. However, the effects of Sudarshan Kriya Yoga (SKY) on autonomic function in this population is unknown. To test the hypothesis that SKY training improves CAC, cardiorespiratory coupling and adaptive response of sympatho-vagal balance to orthostatic changes were evaluated in patients with anxiety and/or depression disorders.
The authors will enroll patients with a diagnosis of anxiety and/or depression disorders (DSM-IV) and they will divide them in two groups: 1) conventional therapy (Control) and 2) conventional therapy associated with SKY (Treatment) for 15 days. Anxiety and depression levels will be determined using quantitative questionnaires. For the assessment of CAC and cardiorespiratory coupling, cardiorespiratory traces will be analyzed using monovariate and bivariate autoregressive spectral analysis, respectively.
- Conditions
- Anxiety, Depression
- Being tested
- SKY therapy, usual drug therapy
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKY therapyOther
slow breathing
usual drug therapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Sky | Experimental | Sky treatment foe 15 days Receives: Other: SKY therapy |
| control | Sham comparator | standard medical therapy Receives: Drug: usual drug therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in autonomic control
Parameter derived from heart rate variability: LF/HF (marker of sympatho-vagal balance)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startMar 2011
- Primary completionSep 2011
- Study completionMar 2012
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 AnxietyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Tobaldini, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828072
- Sponsor's protocol ID
- SKY-1
- Status last verified
- Jul 2016
- First submitted
- 30 Jun 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Toschi-Dias E, Tobaldini E, Solbiati M, Costantino G, Sanlorenzo R, Doria S, Irtelli F, Mencacci C, Montano N. Sudarshan Kriya Yoga improves cardiac autonomic control in patients with anxiety-depression disorders. J Affect Disord. 2017 May;214:74-80. doi: 10.1016/j.jad.2017.03.017. Epub 2017 Mar 7.
PubMed 28285240
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sudarshan Kriya Yoga on Cardiac Autonomic Control and Anxiety/Depression Levels in Patients Affected by Anxiety-Depression Disorders
- ClinicalTrials.gov ID
- NCT02828072
- Acronym / sponsor ID
- SKY-1
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Jul 2016 (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.
The effects of Sudarshan Kriya Yoga (SKY) on autonomic function in patients with anxiety-depression disorders is unknown. Thus, the authors will investigate cardiac autonomic control in a population of patients with anxiety-depression disorders which will undergo a specific SKY treatment.
Detailed description
Several studies have demonstrated that adjuvant therapies as exercise and breathing training are effective in improving cardiac autonomic control (CAC) in patients with affective spectrum disorders. However, the effects of Sudarshan Kriya Yoga (SKY) on autonomic function in this population is unknown. To test the hypothesis that SKY training improves CAC, cardiorespiratory coupling and adaptive response of sympatho-vagal balance to orthostatic changes were evaluated in patients with anxiety and/or depression disorders.
The authors will enroll patients with a diagnosis of anxiety and/or depression disorders (DSM-IV) and they will divide them in two groups: 1) conventional therapy (Control) and 2) conventional therapy associated with SKY (Treatment) for 15 days. Anxiety and depression levels will be determined using quantitative questionnaires. For the assessment of CAC and cardiorespiratory coupling, cardiorespiratory traces will be analyzed using monovariate and bivariate autoregressive spectral analysis, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sky | Experimental | Other: SKY therapySky treatment foe 15 days |
| control | Sham comparator | Drug: usual drug therapystandard medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of anxiety-depression disorder
Key exclusion criteria (2 listed)
- absence of sinus rhythm on ECG
- absence of any cardiovascular and metabolic 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 |
|---|---|---|
| SKY therapyslow breathing | Other | Sky |
| usual drug therapy | Drug | control |
Primary outcome
Changes in autonomic control
Time frame: 1 month
Parameter derived from heart rate variability: LF/HF (marker of sympatho-vagal balance)
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 11 Jul 2016.
- Derived from this study: PubMed 28285240Toschi-Dias E, Tobaldini E, Solbiati M, Costantino G, Sanlorenzo R, Doria S, Irtelli F, Mencacci C, Montano N. Sudarshan Kriya Yoga improves cardiac autonomic control in patients with anxiety-depression disorders. J Affect Disord. 2017 May;214:74-80. doi: 10.1016/j.jad.2017.03.017. Epub 2017 Mar 7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SKY therapy and usual drug therapy in people with Anxiety and Depression, run by University of Milan.
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 1 inclusion and 2 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 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Changes in autonomic control (time frame: 1 month). 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 NCT02828072, 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 11 Jul 2016.