Biosound Therapy as a Treatment for Long COVID Patients

NCT05848401 | Completed

• 1 other identifier: 21-ANXI-101
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Long COVID

Keywords

long COVID; long haulers; post COVID syndrome; vibroacoustic therapy; biofeedback

Outcome Measures

Primary Outcomes (4)

• The Patient Health Questionnaire (PHQ-9)

  9-item questionnaire assessing for Major Depressive Disorder

  4 weeks

• Generalized Anxiety Disorder 7-item scale (GAD-7)

  7-item questionnaire assessing for generalized anxiety disorder

  4 weeks

• Cambridge Brain Sciences (CBS) tasks

  The CBS tasks measure reasoning, short-term memory, and verbal ability through 12 online tasks simulating puzzles or video games.

  4 weeks

• COVID-19 Persistent Symptom Questionnaire.

  The authors developed The COVID-19 Persistent Symptom Questionnaire to measure common persistent COVID-19 symptoms at their worst over the last week on a scale of 0-3.

  4 weeks

Secondary Outcomes (3)

• Recruitment Rate

  Through study completion, an average of 1 year

• Retention Rate

  4 weeks

• Open-ended questions to participants about their experience

  4 weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

The treatment group will be given the following assessments at baseline and four weeks post-randomization: the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder 7-item scale (GAD-7), Cambridge Brain Sciences (CBS) tasks, and the COVID-19 Persistent Symptom Questionnaire. The principal investigator will schedule two Biosound Therapy sessions per week for four weeks for all treatment group participants. The treatment sessions will not occur on consecutive days. All participants in the treatment group will listen to identical playlists. At the beginning of the BTS session, the participant will complete a session of HeartMath biofeedback. Next, the participant will receive approximately 30-40 minutes of music containing binaural beats synchronized with sound massage.The session will finish with gratitude-based video content.

Device: Biosound Therapy System

Control Group

NO INTERVENTION

The control group will be given the following assessments at baseline and four weeks post-randomization: the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder 7-item scale (GAD-7), Cambridge Brain Sciences (CBS) tasks, and the COVID-19 Persistent Symptom Questionnaire. Control group participants were given a complimentary Biosound Therapy session and a ten dollar gift card upon completion of their final assessments.

Interventions

Biosound Therapy System DEVICE

Biosound Therapy consists of biofeedback, vibroacoustic therapy synchronized with music that plays binaural beats, and video content.

Also known as: vibroacoustic therapy, biofeedback, binaural beats

Treatment Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• experiencing at least three symptoms that began or were intensified due to COVID
• able to provide documentation of a COVID-19 test older than 30 days.
• years old.

You may not qualify if:

• abusing alcohol or drugs
• having a pacemaker or any other implanted devices
• pregnancy
• history of the following conditions: blood clots, schizophrenia, seizures, recent head injury, and any acute physical injury

Sponsors & Collaborators

• Anxiety Relief Center: lead

Study Sites (1)

The Anxiety Relief Center

Fishers, Indiana, 46038, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Colleenia R Korapatti, MA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants were aware they would be placed in the treatment or control group after providing informed consent.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 8, 2023
• Study Start: April 29, 2021
• Primary Completion: January 5, 2022
• Study Completion: January 19, 2022
• Last Updated: May 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available indefinitely after the completion of the study.
• Access Criteria: The principal investigator Colleenia Korapatti will review requests upon contact. Requested information will be shared electronically.

Locations

US (1)