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Behavioural Intervention
Remote Counseling + Sound Therapy for Hyperacusis
N/A
Recruiting
Led By Ann Perreau, PhD
Research Sponsored by Augustana College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have hyperacusis as primary diagnosis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline only
Awards & highlights
Study Summary
This trial will assess if counseling and sound therapy can help manage hyperacusis, a condition with reactions to sound as too loud, annoying, fearful, or painful.
Who is the study for?
This trial is for individuals with hyperacusis, a condition where sounds are perceived as too loud or painful. Participants must have access to a smartphone or computer and should not have severe tinnitus, profound hearing loss, or recent hyperacusis treatment.Check my eligibility
What is being tested?
The study tests two treatments for hyperacusis: remote counseling via videos and activities (HAT-Online), and sound therapy either through gradual exposure to bothersome sounds or continuous low-level background noise. The effectiveness of these methods will be compared over four weeks.See study design
What are the potential side effects?
Potential side effects may include discomfort from listening to bothersome sounds during sound therapy sessions. However, since the interventions are non-invasive and involve counseling and controlled sound exposure, significant side effects are unlikely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My main health issue is extreme sensitivity to sounds.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measurements will be completed four times during the study: 1) baseline, 2) four weeks (before aim 1), 3) eight weeks (end aim 1, before aim 2), and 4) 12 weeks (end aim 2).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measurements will be completed four times during the study: 1) baseline, 2) four weeks (before aim 1), 3) eight weeks (end aim 1, before aim 2), and 4) 12 weeks (end aim 2).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in hyperacusis symptoms from baseline to counseling at 8 weeks and sound therapy at 12 weeks
Secondary outcome measures
Change in disability resulting from hyperacusis assessed at baseline to counseling at 8 weeks and sound therapy at 12 weeks
Change in hyperacusis problems from baseline to counseling at 8 weeks and sound therapy at 12 weeks
Change in quality of life from baseline to counseling at 8 weeks and sound therapy at 12 weeks
+1 moreOther outcome measures
Tinnitus Primary Functions Questionnaire (TFPQ)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sound therapyExperimental Treatment2 Interventions
In Aim 2, the investigators will randomize the 60 participants to receive intervention using one of the two sound therapy approaches. Group 1: Listening to bothersome sounds or Group 2: Listening to low-level background noise.
Group II: HAT-Online CounselingExperimental Treatment1 Intervention
In Aim 1, the investigators will provide remote counseling for four weeks to 60 participants and compare results to baseline. All participants will be in a wait list control for four weeks before the counseling begins.
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Who is running the clinical trial?
Augustana CollegeLead Sponsor
Ann Perreau, PhDPrincipal InvestigatorAugustana College
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received treatment or counseling for hyperacusis in the last two months.I have severe or profound hearing loss.I have severe ringing in my ears.My main health issue is extreme sensitivity to sounds.
Research Study Groups:
This trial has the following groups:- Group 1: HAT-Online Counseling
- Group 2: Sound therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for individuals to take part in this research?
"According to clinicaltrials.gov, the recruitment for this trial has been temporarily suspended since July 26th 2023. Despite its inactive status, there are 4 alternative trials that have begun recruiting patients at present."
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