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CTRI Number  CTRI/2025/07/091338 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 19/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of slow breathing exercises along with usual treatment on heart rate and symptoms in patients suffering from postural orthostatic tachycardia syndrome 
Scientific Title of Study   Effect of Resonance Frequency Paced Breathing as an Adjuvant to Standard Treatment on Heart Rate and Cardiac Autonomic Parameters in Patients with Postural Orthostatic Tachycardia Syndrome: A Randomized Controlled Trial 
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 Raihan Mannan 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Department of Physiology, AIIMS Patna, Patna, Bihar

Patna
BIHAR
801505
India 
Phone  8218225643  
Fax    
Email  dr.raihan11456@aiimspatna.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Raihan Mannan 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Department of Physiology, AIIMS Patna, Patna, Bihar

Patna
BIHAR
801505
India 
Phone  8218225643  
Fax    
Email  dr.raihan11456@aiimspatna.org  
 
Details of Contact Person
Public Query  
Name  Dr Raihan Mannan 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Department of Physiology, AIIMS Patna, Patna, Bihar

Patna
BIHAR
801505
India 
Phone  8218225643  
Fax    
Email  dr.raihan11456@aiimspatna.org  
 
Source of Monetary or Material Support  
Intramural Funding All India Institute of Medical Sciences Patna, Phulwari Sharif, Patna, Bihar, India Pin: 801507 
 
Primary Sponsor  
Name  AIIMS Patna 
Address  All India Institue of Medical Sciences Patna, Phulwari Sharif, Patna, Bihar, India Pin: 801507 
Type of Sponsor  Research institution and hospital 
 
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 Raihan Mannan  All India Institute of Medical Sciences Patna  Department of Physiology, Admin Building, AIIMS Patna, Patna, Bihar
Patna
BIHAR 		 8218225643

dr.raihan11456@aiimspatna.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G909||Disorder of the autonomic nervoussystem, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Resonance frequency paced breathing intervention  Participants will perform resonance frequency paced breathing for 20 minutes twice a day in the morning and evening, 6 days per week, for 1 month as an adjuvant to their standard treatment. The patient will be trained to do Resonance Frequency paced breathing using a pacer application (Breathe, version 3.2.23) on the phone by trained staff, with subsequent sessions performed at home using the mobile application with live video monitoring. 
Comparator Agent  Standard Treatment Group   Participants will receive standard treatment without any paced breathing intervention 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. All subjects were diagnosed with POTS by an experienced physician, based on the following parameters:
a. Sustained increase in HR of equals to or more than 30 beats/min (within the first 10 min of HUT) in the absence of orthostatic hypotension.
b. Orthostatic complaints for at least 3 months that ameliorated on return to the supine position.
2. Able to provide informed consent and adhere to the intervention schedule.
3. No prior training in resonance frequency breathing techniques.
 
 
ExclusionCriteria 
Details  1. Presence of other cardiovascular, neurological, or psychiatric conditions
2. Current use of medications that significantly affect symptoms
3. Pregnancy or lactation
4. Cardiac pacemakers, severe heart failure or any other cardiovascular abnormality
5. Moderate to severe sensorimotor polyneuropathy
6. Neurodegenerative diseases
7. Uncontrolled Diabetes mellitus
8. Drug abuse
9. Anemia
10. Untreated hyperthyroidism
11. Prolonged bed rest 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in heart rate response during the tilt table test (with and without resonance paced breathing).
Mean HR
Maximum HR
Minimum HR 		 At Baseline
After 2 Weeks
After 4 Weeks (Termination of Intervention)
After 6 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Changes in HRV parameters
2. Classical Autonomic Function Tests
3. Changes in POTS symptoms as assessed by validated questionnaire 		 1-14 Months: Patient recruitment and baseline data collection
2-16 Months: Intervention Phase
3-18 Months: Post Intervention Assessment
13-20 Months: Data Analysis
21-24 Months: Report Writing, Manuscript preparation and Dissemination of findings 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   01/08/2025 
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="2"
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  

Background: POTS is an autonomic disorder that significantly impacts the quality of life, with limited treatment options available. While symptomatic management remains the primary approach, there is a growing need for alternative, non-pharmacological interventions. RF-paced breathing, a controlled breathing technique that synchronizes heart rate and respiration, has shown potential in improving autonomic function and heart rate variability (HRV), offering a novel therapeutic strategy.

Novelty: Unlike existing studies that primarily assess the short-term effects of slow breathing, this study introduces a novel approach by utilizing extended RF breathing sessions as an adjunct to standard POTS treatment.

Objectives: The primary objective is to assess effects of RF-paced breathing on heart rate response, cardiac autonomic parameters, and symptomatology in patients with POTS. By investigating its long-term efficacy, the study seeks to determine whether RF-paced breathing can serve as a viable alternative to pharmacological treatments.

Methods: A randomized controlled trial design will be used, with participants randomly assigned to a group receiving RF-paced breathing in addition to standard treatment or to a control group. The study will measure heart rate, HRV, and POTS-related symptoms at baseline and follow-up time points.

Expected Outcomes: This study is expected to provide insights into the sustained effects of RF-paced breathing on autonomic function and POTS symptoms, with potential for establishing a non-pharmacological approach to managing the disorder. 
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