Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05848401
Status:
COMPLETED
Last Update Posted:
2023-05-08
First Post:
2023-05-05
Brief Title:
Biosound Therapy as a Treatment for Long COVID Patients
Sponsor:
Anxiety Relief Center
Organization:
Anxiety Relief Center
Study Overview
Official Title:
Biosound Therapy as a Treatment for Long COVID Patients A Randomized Pilot Trial
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aimed to explore the impact of the Biosound Therapy Systerm on long COVID symptoms while determining feasibility of a future full-scale Randomized Controlled Trial It was hypothesized that Biosound treatment would significantly improve long COVID
The goal of this clinical trial is to learn about Biosound Therapy Systems impact on long COVID symptoms The main questions it aims to answer are
How does Biosound Therapy impact long COVID symptoms
Is the protocol for this trial feasible for a future full-scale Randomized Controlled Trial
Participants with long COVID symptoms will be assigned to a control group and treatment group The control group will receive no treatment The treatment group will have 8 sessions of Biosound Therapy Researchers will compare the treatment and control group to see if theres a difference in long COVID symptoms
The goal of this clinical trial is to learn about Biosound Therapy Systems impact on long COVID symptoms The main questions it aims to answer are
How does Biosound Therapy impact long COVID symptoms
Is the protocol for this trial feasible for a future full-scale Randomized Controlled Trial
Participants with long COVID symptoms will be assigned to a control group and treatment group The control group will receive no treatment The treatment group will have 8 sessions of Biosound Therapy Researchers will compare the treatment and control group to see if theres a difference in long COVID symptoms
Detailed Description:
Investigators will recruit participants through social media and word of mouth They will also share the study information with practitioners businesses organizations research departments universities and the community Participants will email or call The Anxiety Relief Center to inquire about participating in the study
Initial screening procedures will take place using the receptionist script to determine eligibility of participants Eligible participants who agree to participate in the study will then be asked to come into the office for an intake at a time convenient for them This appointment will include signing the consent form and the completion of initial assessments Cambridge Brain Sciences tasks PHQ9 GAD7 and the COVID-19 Persistent Symptom Questionnaire
After a participant has completed the initial intake appointment the participant will be randomly assigned to the treatment or control group using Randomizerorg a computer-generated randomizer Each participant will be informed if they were assigned to the treatment or control group An investigator will schedule two Biosound Therapy sessions per week for four weeks with every participant in the treatment group
The Biosound Therapy System BTS is a system that utilizes biofeedback vibroacoustic technology and binaural beats Vibroacoustic Technology uses sinusoidal low-frequency rhythmical pulsing sound waves in conjunction with music The BTS device does not send electricity through the body rather the device uses amplifiers embedded into an adjustable bed to send frequencies between 40 and 70 Hz into the body
At the beginning of the BTS session the participant will complete the Biosound Technologies Pretest questionnaire and then will be instructed to sit on the BTS platform to begin utilizing HeartMath technology that will collect data on heart rate variability HRV An investigator will assist the client in attaching a finger sensor around their index finger as they recline onto the platform so that they are facing a monitor positioned in front of the platform The monitor digitally portrays the participants HRV and allows the participant to visually see how the rate of their breath is connected to their HRV The participant spends a few minutes trying to match their breath rate with a moving icon called a breath pacer that is shown on the monitor The icon moves up and down at the rate of the clients target heart rate The monitor also displays corresponding coherence levels which refer to the stability and balance between the brain and nervous system HeartMath Institute 2016 The coherence levels are color coordinated with the levels of low medium and high A high coherence level signifies high stability balance and regulation whereas a low coherence level signifies instability imbalance and dysregulation A person with a high coherence level can operate with high efficiency Once the participant improves their coherence level and HRV about 5-10 minutes an investigator will remove the finger sensor and instruct the participant to put on headphones
Then an investigator will begin a playlist that includes music with binaural beats that is synchronized with sound massage Once the playlist has begun an investigator will turn off the lights and exit the room until the playlist is finished The session ends with video content Each participant will be given an identical playlist for each session At the end of the session the participant will complete the Biosound Technologies Posttest questionnaire to assess the perceived effects of the session
All collected data will be deidentified and stored in a HIPAA compliant electronic medical record system called Therapy Appointment After a participant in the treatment group has completed their treatment sessions they will complete the same assessments given at intake After the assessments are completed an investigator will ask 2 open-ended questions and then will record a summary of their answers
While Biosound Therapy rarely causes side effects some people may experience dizziness or discomfort While adverse reactions are rarely reported a decreased sense of anxiety can feel unfamiliar to people who are used to a state of physiological increased awareness As stated above the BTS is a wellness device that was designed to provide relief and side effects are rarely reported All participants will be told that they can stop treatment at any time during the session by leaving the treatment room An investigator will be in close proximity to the treatment room at all times to provide any needed assistance during participants sessions Snacks water guidance and emotional support will be available to participants should they experience any side effects Additionally HRV allows subjects an opportunity to see a balanced and healthy state and can help center a client who may be feeling dizzy after sound massage The investigators will record any adverse side effects reported by the participants
The process measures of recruitment and retention rates open-ended interview responses and participant characteristics will be summarized using descriptive statistics Due to the small sample size the Wilcoxon signed-rank test will be used to determine changes in the variables for the intervention and control group
Initial screening procedures will take place using the receptionist script to determine eligibility of participants Eligible participants who agree to participate in the study will then be asked to come into the office for an intake at a time convenient for them This appointment will include signing the consent form and the completion of initial assessments Cambridge Brain Sciences tasks PHQ9 GAD7 and the COVID-19 Persistent Symptom Questionnaire
After a participant has completed the initial intake appointment the participant will be randomly assigned to the treatment or control group using Randomizerorg a computer-generated randomizer Each participant will be informed if they were assigned to the treatment or control group An investigator will schedule two Biosound Therapy sessions per week for four weeks with every participant in the treatment group
The Biosound Therapy System BTS is a system that utilizes biofeedback vibroacoustic technology and binaural beats Vibroacoustic Technology uses sinusoidal low-frequency rhythmical pulsing sound waves in conjunction with music The BTS device does not send electricity through the body rather the device uses amplifiers embedded into an adjustable bed to send frequencies between 40 and 70 Hz into the body
At the beginning of the BTS session the participant will complete the Biosound Technologies Pretest questionnaire and then will be instructed to sit on the BTS platform to begin utilizing HeartMath technology that will collect data on heart rate variability HRV An investigator will assist the client in attaching a finger sensor around their index finger as they recline onto the platform so that they are facing a monitor positioned in front of the platform The monitor digitally portrays the participants HRV and allows the participant to visually see how the rate of their breath is connected to their HRV The participant spends a few minutes trying to match their breath rate with a moving icon called a breath pacer that is shown on the monitor The icon moves up and down at the rate of the clients target heart rate The monitor also displays corresponding coherence levels which refer to the stability and balance between the brain and nervous system HeartMath Institute 2016 The coherence levels are color coordinated with the levels of low medium and high A high coherence level signifies high stability balance and regulation whereas a low coherence level signifies instability imbalance and dysregulation A person with a high coherence level can operate with high efficiency Once the participant improves their coherence level and HRV about 5-10 minutes an investigator will remove the finger sensor and instruct the participant to put on headphones
Then an investigator will begin a playlist that includes music with binaural beats that is synchronized with sound massage Once the playlist has begun an investigator will turn off the lights and exit the room until the playlist is finished The session ends with video content Each participant will be given an identical playlist for each session At the end of the session the participant will complete the Biosound Technologies Posttest questionnaire to assess the perceived effects of the session
All collected data will be deidentified and stored in a HIPAA compliant electronic medical record system called Therapy Appointment After a participant in the treatment group has completed their treatment sessions they will complete the same assessments given at intake After the assessments are completed an investigator will ask 2 open-ended questions and then will record a summary of their answers
While Biosound Therapy rarely causes side effects some people may experience dizziness or discomfort While adverse reactions are rarely reported a decreased sense of anxiety can feel unfamiliar to people who are used to a state of physiological increased awareness As stated above the BTS is a wellness device that was designed to provide relief and side effects are rarely reported All participants will be told that they can stop treatment at any time during the session by leaving the treatment room An investigator will be in close proximity to the treatment room at all times to provide any needed assistance during participants sessions Snacks water guidance and emotional support will be available to participants should they experience any side effects Additionally HRV allows subjects an opportunity to see a balanced and healthy state and can help center a client who may be feeling dizzy after sound massage The investigators will record any adverse side effects reported by the participants
The process measures of recruitment and retention rates open-ended interview responses and participant characteristics will be summarized using descriptive statistics Due to the small sample size the Wilcoxon signed-rank test will be used to determine changes in the variables for the intervention and control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None