Clinical trial for Loudness Hyperacusis
Official title Transitional Intervention for Hyperacusis in Autism
ClinicalTrials.gov ID: NCT07798297
What this study is testing
- What it's testing
- The main goal of this clinical trial is to evaluate the effectiveness, benefits, and post-treatment persistence of an intervention for loudness hyperacusis in adults with autism spectrum disorder (ASD). The main questions it aims to answer are: Does the intervention increase loudness tolerance Does the intervention reduce symptoms related to loudness hyperacusis Researchers will compare measures related to loudness hyperacusis before, during, and after the intervention.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 39
You may be able to join if
- Adults age 18 to 39 years
- Autism spectrum disorder
- Mild-to-severe loudness hyperacusis indicated by a score ≥ 22 on the Hyperacusis Questionnaire (HQ) and LDLs for tones ≤ 80 dB HL at two or more...
- No more than slight or mild sensorineural hearing loss from 250 to 8000 Hz
- Normal tympanograms consistent with normal middle ear function
You likely can't join if
- Management for head trauma within the past 6 months
- Management for traumatic brain injury within the past 6 months
- Management for epilepsy within the past 6 months
- Management for seizures within the past 6 months
- Management for or other neurological disorders within the past 6 months
- Otologic surgical procedures within the past 6 months
See the full eligibility criteria
- Adults age 18 to 39 years
- Autism spectrum disorder
- Mild-to-severe loudness hyperacusis indicated by a score ≥ 22 on the Hyperacusis Questionnaire (HQ) and LDLs for tones ≤ 80 dB HL at two or more audiometric frequencies in at least one ear.
- No more than slight or mild sensorineural hearing loss from 250 to 8000 Hz
- Normal tympanograms consistent with normal middle ear function
- Normal "tone" decay response for "comfortable but soft" broadband noise
- Ability understand informed consent in English
- Availability and willingness to conform to the study visit schedule
- Diagnosis of autism (including Asperger's and other diagnoses "on the spectrum")
- Ritvo Autism Asperger Diagnostic Scale-Revised (RAADS-R) score of 65 or greater to confirm ASD diagnosis
- Full-Scale IQ score of 90 or greater on the Weschler Abbreviated Scale of Intelligence (WASI-II; 2-lists).
- Management for head trauma within the past 6 months
- Management for traumatic brain injury within the past 6 months
- Management for epilepsy within the past 6 months
- Management for seizures within the past 6 months
- Management for or other neurological disorders within the past 6 months
- Otologic surgical procedures within the past 6 months
- Actively fluctuating hearing loss within the past 6 months
- Acute Meniere's disease within the past 6 months
- Labyrinthitis within the past 6 months
- Conductive hearing loss
- Otalgia
- Ongoing use of ototoxic medications.
- Active or past drug or alcohol dependent histories
- Known scheduling or travel conflicts
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orlando, Florida, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.