Biosound Therapy as a Treatment for Long COVID Patients
Condition: Long COVID
MeSH terms: Post-Acute COVID-19 Syndrome
Study type: Interventional

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 System's 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
      there's 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 Randomizer.org, 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 participant's 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 client's 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.
    

Intervention name(s): Biosound Therapy System
Intervention type(s): Device
Intervention description(s): Biosound Therapy consists of biofeedback, vibroacoustic therapy synchronized with music that plays binaural beats, and video content.
Other intervention name(s): vibroacoustic therapy; biofeedback; binaural beats
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: long COVID; long haulers; post COVID syndrome; vibroacoustic therapy; biofeedback