Pranayama Practice on the Autonomic Nervous System
Condition: Pranayama Effect on Autonomic Nervous System; Respiration Variability Effect on Nervous System
MeSH terms: Neurologic Manifestations
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The proposed study design will be a randomized, cross-over trial testing different pranayama
      breathing interventions. Participants (N=40) will perform each of the following five
      interventions in a randomly assigned order: (1) internal-paced pranayama intervention
      (Sheetali/Sheetkari for 10 minutes each) (2) internal-paced deep breathing control (3)
      external-paced pranayama intervention at a rate of 6 bpm (4) external-paced deep breathing at
      a rate of 6 bpm (5) sitting quietly with no external instruction.
    

Detailed description: 
      Healthy adult participants (N=40) will be recruited from the general population. Potential
      participants will contact a study phone line or email expressing their interest, and they
      will then be contacted in order to schedule a screening telephone interview for an initial
      assessment of their eligibility. Recruitment will be conducted in the general community using
      flyers, newspaper advertisements, radio advertisements, and web advertising. NUNM students,
      faculty, staff and patients will not be specifically targeted for recruitment, although they
      may see a posted flyer and decide to contact study staff.Screening for potential participants
      will occur over the phone, using a standardized telephone script and during the first study
      visit. Prior to all clinical research visits, participants will be called and reminded how to
      prepare, i.e., avoid extreme physical exercise for one day and refrain from alcohol,
      caffeinated beverages, and recreational drugs for twelve hours before coming to clinic. The
      participant will be queried about alcohol, caffeinated beverages, over-the-counter
      medications, and recreational drugs at the beginning of each visit. If they are not compliant
      with these instructions, they will be asked to either reschedule their visit until they
      report compliance or withdraw from the study if compliance is not feasible.

        -  Height and weight will be measured and recorded and BMI will be calculated (Visit 1
           only, if out of range then participant does not meet inclusion criteria and will not be
           enrolled).

        -  Heart rate (HR) and blood pressure (BP) will be recorded after the volunteer has been
           sitting calmly for 5 minutes. The mean of 3 successive recordings with at least 2
           minutes between readings will be calculated and recorded as the BP and HR for the visit.
           (Visit 1 only if out of range then participant does not meet inclusion criteria and will
           not be enrolled)

        -  Participants will fill out the pretreatment Mind Body Awareness (visit one and five
           only) and the Positive Affect Negative Affect Scale (PANAS) questionnaires in order to
           assess baseline mood.

        -  Participants will be connected to the ProComp8 infinity Encoder (Thought Technologies)
           for physiological measurements of EKG (for HR and HRV). For EKG measurement electrodes
           will be placed on the wrist using adjustable bands. For respiratory measurements
           thoracic and abdominal sensors will go around the body.

        -  The order of the following conditions will be randomly assigned (1) self-paced pranayama
           intervention (Sheetali/Sheetkari consecutively for 10 minutes each) (2) self-paced deep
           breathing control (3) external-paced pranayama intervention at a rate of 6 bpm (4)
           external-paced deep breathing at a rate of 6 bpm (5) sitting quietly with no external
           instruction.

        -  Before and after measurements will be recorded with the participant's eye open and
           focused on a on screen image and with eyes closed. This is a common practice in the
           measurement of EEG due to shifts in Alpha state brain waves when the eyes are closed.

        -  Each session will follow the pattern below:

             1. Pre- PANAS questionnaire

             2. Intro screen (one activity)

                a. Reviews activities with the participant

             3. Sensor placement

                  1. Respiration instructions

                  2. EKG instructions

                  3. EEG instructions

             4. Eyes open before

                  1. Instructions

                  2. Measurement

             5. Eyes closed before

                  1. Instructions

                  2. Measurement

             6. Breathing exercise (Activities unique to each condition with video instructions)

                  1. Instructions

                  2. Video instructed breath measurement

             7. Eyes open after

                  1. Instructions

                  2. Measurement

             8. Eyes closed after

                  1. Instructions

                  2. Measurement

             9. Removal of sensors

                a. Instruction

            10. Post PANAS questionnaire

        -  Throughout the session participants will be comfortably seated in a chair and instructed
           to keep their spine erect. The total duration of each HRV measurement will be about 40
           minutes: 10 minutes before the practice, 20-minute video with instructions for each
           condition (broken up into 5 min sections to allow rest), and 10 minutes after the
           practice.
    

Intervention name(s): Sheetali/Sheekari Pranayama; Sitting Quietly; Deep breathing
Intervention type(s): Other; Other; Other
Intervention description(s): Most pranayama involves (1) sitting quietly, (2) deep breathing (completely filling and emptying the lungs, at a slow/comfortable pace, with awareness), and (3) a specific mouth, tongue, lip and/or body shape, theorized to enhance the effects of the practice. Practitioners of pranayama modulate the cycles of inspiration and expiration, in a way that is theorized to achieve influence over autonomic functions such as heart rate, heart rate variability (HRV), and baroreflex [6]. For example, the manipulation of the tongue and face during Sheetali and Sheetkari pranayama is intended to stimulate parasympathetic nervous system activity and inhibit the sympathetic nervous system.; Participant breaths in their natural way with out instruction; Participant is required to pay attention to each breath
Other intervention name(s): Pranayama deep breathing
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Heart Rate Variability; EEG; Respiration