| 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
|
|
|
Primary Sponsor
|
| Name |
AIIMS Guwahati |
| Address |
Changsari Guwahati Assam |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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. |