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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02828072
Other study ID # SKY-1
Secondary ID
Status Completed
Phase N/A
First received June 30, 2016
Last updated July 6, 2016
Start date March 2011
Est. completion date March 2012

Study information

Verified date July 2016
Source University of Milan
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 2012
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- diagnosis of anxiety-depression disorder

Exclusion Criteria:

- absence of sinus rhythm on ECG

- absence of any cardiovascular and metabolic disorder

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
SKY therapy
slow breathing
Drug:
usual drug therapy


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Milan

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in autonomic control Parameter derived from heart rate variability: LF/HF (marker of sympatho-vagal balance) 1 month No
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