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NCT05976789 · ClinicalTrials.gov registry record · NA
A Feasibility Study of a Novel, Fully Remote Counseling and Sound Therapy Program for Hyperacusis
A NA study of Hyperacusis, sponsored by Augustana College.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05976789 is a NA study of Hyperacusis that is actively recruiting participants, run by Augustana College. The registered enrollment target is 60 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05976789, a NA study of Hyperacusis, is actively recruiting participants, sponsored by Augustana College.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
There is no universal approach used to treat hyperacusis, a condition defined as having reactions to sound as too loud, annoying, fearful, or painful. A collaborative report published by prominent researchers recommended counseling and sound therapy for managing hyperacusis, but emphasized the need for rigorously designed clinical trials to assess the effectiveness of these treatments. The investigators developed a face-to-face counseling approach, Hyperacusis Activities Treatment (HAT), and have demonstrated its effectiveness for in-person therapy. In this study, the investigators will conduct a controlled trial to evaluate the effectiveness of the two components of HAT in managing hyperacusis: Aim 1, remotely delivered counseling, and Aim 2, sound therapy. In Aim 1, participants will complete four weeks of remote counseling using instructional videos, homework activities, discussion forums, and hands-on exercises. To ensure rigor in the approach, all participants will complete 4 weeks of weekly monitoring (control) before beginning counseling (treatment) for an additional 4 weeks. In aim 2, participants will be randomized into one of two sound therapy groups: (1) Group 1: Listen to their individually chosen bothersome sounds using successive approximations or a gradual increase in sound level; and (2) Group 2: Listen to continuous, low-level background noise. In both groups, devices will be fit remotely and used for 1-2 hours per day for four weeks. Completion of this R15 Academic Research Enhancement Award project at Augustana College will lead to a shift in hyperacusis management by providing early clinical evidence for the effectiveness of the components that make up the HAT protocol: counseling and sound therapy.
Conditions Studied
Interventions
- DEVICE Sound therapy using low-level background sound
- BEHAVIORAL Remote counseling using HAT-Online
- OTHER Sound therapy using successive approximations
Study Locations (1)
Illinois
- Augustana College - Rock Island
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-12-18 |
| Est. Completion | 2026-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05976789
The ClinicalTrials.gov registry entry for NCT05976789 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Augustana College, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hyperacusis appearing as the primary indexed condition, and to 3 interventions - of which Sound therapy using low-level background sound is the first listed.
NCT05976789 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT05976789 about?
NCT05976789 is a clinical study titled "A Feasibility Study of a Novel, Fully Remote Counseling and Sound Therapy Program for Hyperacusis". There is no universal approach used to treat hyperacusis, a condition defined as having reactions to sound as too loud, annoying, fearful, or painful. A collaborative report published by prominent researchers recommended counseling and sound therapy for managing hyperacusis, but emphasized the need ...
What is the current status of trial NCT05976789?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2023-12-18. Estimated completion is 2026-05.
What conditions does trial NCT05976789 study?
This clinical trial studies the following conditions: Hyperacusis.
What interventions are being tested in trial NCT05976789?
The interventions under investigation include: Sound therapy using low-level background sound (DEVICE), Remote counseling using HAT-Online (BEHAVIORAL), Sound therapy using successive approximations (OTHER).
Who is sponsoring clinical trial NCT05976789?
This trial is sponsored by Augustana College, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05976789 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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