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CTRI Number  CTRI/2026/01/101270 [Registered on: 15/01/2026] Trial Registered Prospectively
Last Modified On: 10/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Heart rate variability Biofeedback and Binaural Beats on Autonomic Status in Healthy Adults 
Scientific Title of Study   Comparison of the Effects of Heart rate variability Biofeedback and Binaural Beats on Autonomic Modulation in Adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bharatbhai Karamata 
Designation  Junior resident Academic 
Affiliation  AIIMS Guwahati 
Address  Department of Physiology

Kamrup
ASSAM
781101
India 
Phone  9081717717  
Fax    
Email  bdkaramata@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhishek Sinha 
Designation  Additional Professor 
Affiliation  AIIMS Guwahati 
Address  Department of Physiology

Kamrup
ASSAM
781101
India 
Phone    
Fax    
Email  abhsheksinha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bharatbhai Karamata 
Designation  Junior resident Academic 
Affiliation  AIIMS Guwahati 
Address  Department of Physiology

Kamrup
ASSAM
781101
India 
Phone  9081717717  
Fax    
Email  bdkaramata@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  AIIMS Guwahati 
Address  Changsari Guwahati Assam 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharatbhai Karamata  AIIMS Guwahati  room number 07058 Autonomic function lab Department of physiology first floor Changsari Guwahati Assam
Kamrup
ASSAM 
9081717717

bdkaramata@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS GUWAHATI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adults of Male and female genders (preferably from and near by AIIMS Guwahati campus), BMI 30 , Aged between 18 to 50years. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Binaural Beat listening  binaural beats (BB)—an auditory stimulation method where two slightly different frequencies are delivered separately to each ear, producing a perceived beat frequency—offer another non-invasive route to modulate neural and autonomic activity. The beat is thought to entrain neural oscillations corresponding to desired brain-wave states (for example, theta or alpha), and through neural–autonomic coupling, may influence ANS tone  
Intervention  Heart Rate Variability Biofeedback  HRV biofeedback (HRVB) has gained traction as a behavioral technique to consciously regulate breathing and heart rhythm via real-time feedback. It uses “resonance frequency breathing” (approximately 0.1 Hz or ~6 breaths per minute) to amplify heart-rate oscillations and baroreflex sensitivity, thereby increasing vagal tone and improving autonomic balance. Mechanistically, HRVB enhances afferent vagal signalling and improves autonomic flexibility by strengthening baroreflex function 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Healthy adults of Male and female genders
Residing preferably from and near by AIIMS Guwahati campus
BMI less than 30
 
 
ExclusionCriteria 
Details  Any h/o Chronic metabolic disorders
Any h/o cardiovascular diseases
Any h/o neurological disorders
Any h/o hearing disorders
Any h/o severe cutaneous disorders
Not performing breathing exercise/pranayama during study period 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Both interventions are expected to improve HRV parameters, with HRV biofeedback producing greater enhancement in vagal modulation compared to binaural beats  Both interventions are expected to improve HRV parameters, with HRV biofeedback producing greater enhancement in vagal modulation compared to binaural beats 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction: Heart Rate Variability biofeedback (HRVB) is a technique that enables individuals to consciously modulate their heart rhythm through paced breathing at their resonance frequency, thereby enhancing vagal activity. In contrast, binaural beats—auditory stimuli created by slightly different frequency tones presented to each ear—can entrain brainwave activity and modulate autonomic function through cortical–subcortical pathwaysWhile both HRVB and binaural beats have been independently studied for autonomic modulation, direct comparative studies in healthy individuals are limited. Understanding their relative efficacy could provide insights into optimising non-invasive autonomic training interventions., review of literature:HRV as a key autonomic biomarker reflects the balance between sympathetic and parasympathetic activity strongly linked to stress, cardiovascular health, and emotional regulation HRV biofeedback induces robust autonomic improvements:HRVB strengthens vagal pathways, increases baroreflex gain Binaural beats(BB) influence neural and autonomic activity:BB may entrain brain rhythms (alpha) and modulate parasympathetic tone, though effects vary between individuals BB may enhance HRV under specific conditions:Theta BB improves post-exercise HRV recovery and long-term daily 6 Hz listening increases HRV and cognitive performance.Music with BB also boosts parasympathetic HRV indices., aim(s):To compare the effects of HRV biofeedback and binaural beat stimulation on cardiac autonomic modulation in adults. objectives: To evaluate changes in HRV parameters following two weeks of HRV biofeedback in adults.To evaluate changes in HRV parameters following two weeks of binaural beat interventions in adults.To compare changes in HRV parameters between the two interventions among the study population., justification for study: HRVB consistently enhances HRV and parasympathetic tone, while BB shows promising but heterogeneous results.Directly comparision of these two interventions in healthy adults using repeated HRV parameter measurements for autonomic modulation over time is not done., methodology describing the potential risks & benefits:This study will be a conducted in the Department of Physiology, AIIMS Guwahati.A total of 30 adult volunteers (aged 18–50 years) will be recruited after written informed consent. Participants will be adults. After baseline HRV recording, participants will be randomly allocated (1:1) into two groups using enveloped-number randomization. Group A (HRV Biofeedback Group):Participants perform abdominal breathing at resonance frequency for two weeks for 15 min daily keep journal of same for self-compliance.Group B (Binaural Beats Group):Participants will listen BBF for 2 weeks for 15 minutes everyday at their home and keep journal of same for self-compliance.Each participant will return for HRV recording after 1 week (day 7 ±1), and 2 weeks (day 14 ±1).HRV Recording:Performed using an AD Instrument.Duration: 10 minutes resting ECG.Analysis:LabChartpro.Parameters:Time-domain: SDNN,SDSD,RMSSD,NN50,pNN50,Frequency-domain: Total,VLF,LF,HFpower, Non-linear: SD1, SD2.Statistical Analysis:Data will be analyzed using SPSS. Normality will be assessed using Shapiro–Wilk test.Between-group comparison: Independent t-test.Within-group comparison: Repeated measures ANOVA.Significance level: p < 0.05.

 
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