Clemastine Fumarate + Engineered Sound for Auditory Processing Disorder
(CAPD-LOOT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of the drug Clemastine Fumarate and engineered sound to treat age-related central auditory processing disorder (CAPD). This condition, which affects many people over 40, makes hearing in noisy places difficult. The study aims to determine whether this treatment can improve the ability to distinguish specific sounds from background noise. Individuals with mild hearing loss who struggle to hear clearly in noisy environments might be suitable candidates for this trial. As a Phase 1, Phase 2 trial, the research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain medications like monoamine oxidase inhibitors or CNS depressants (medications that slow down brain activity). It's best to discuss your current medications with the trial team to see if they might be a problem.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that Clemastine Fumarate is generally safe for use. Some studies have tested it for multiple sclerosis at doses considered safe, suggesting it should be safe for short-term use in this trial. Clemastine Fumarate primarily serves as an allergy medicine, which can cause drowsiness and dry mouth, though these effects are usually mild.
The engineered sound is designed to be at a safe volume. Research shows that loud noise can harm hearing, but the sound in this trial remains below harmful levels. Participants will listen to it for only an hour each day, reducing any risk of hearing damage.
Overall, both treatments in this trial include safety measures. Clemastine Fumarate has a history of safe use, and the sound exposure is carefully controlled. Safety monitoring, including blood tests and health checks, will help ensure participant safety during the trial.12345Why are researchers excited about this trial's treatments?
Most treatments for Auditory Processing Disorder (APD) focus on auditory training or hearing aids to improve sound interpretation. However, researchers are excited about Clemastine Fumarate combined with engineered sound because it introduces a pharmaceutical approach that targets the central nervous system. Clemastine Fumarate is an antihistamine that has shown potential in promoting myelination, which may help improve neural processing of auditory information. This unique method could complement traditional treatments by directly enhancing brain function, offering a new avenue to address APD's root causes rather than just its symptoms.
What evidence suggests that this trial's treatments could be effective for age-related central auditory processing disorder?
Research suggests that Clemastine Fumarate might improve sound processing by supporting myelin growth, the protective layer around nerves. This drug has shown promise in treating conditions like multiple sclerosis by enhancing nerve function. In this trial, some participants will receive Clemastine Fumarate combined with specially designed sounds. Early findings indicate this combination could enhance effectiveness for people with auditory processing disorder. These engineered sounds are believed to activate specific brain areas, potentially helping the drug target the right regions. Although understanding all the benefits of this combination is still in its early stages, it shows potential for improving hearing in noisy environments.15678
Who Is on the Research Team?
Achim Klug, PhD
Principal Investigator
Colorado University Anschutz Medical Center
Samuel A Budoff, PhD, MS
Principal Investigator
Colorado University Anschutz Medical Center
Are You a Good Fit for This Trial?
This trial is for people aged 45-65 with age-related central auditory processing disorder. They must be able to hear reasonably well (less than 20 dB hearing loss), have normal ear function, no cognitive deficits, and pass a specific hearing in noise test. Participants need to give written consent and follow study requirements.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Clemastine Fumarate or placebo with engineered sound or placebo sound for one month
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Clemastine Fumarate
- Engineered Sound
Trial Overview
The trial tests if Clemastine Fumarate combined with engineered sound improves the ability to hear in noisy environments compared to placebo treatments. It's an adaptive design with four groups: drug+sound, placebo+sound, drug+white noise, placebo+white noise.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Placebo Group
Active clemastine fumarate + engineered sound stimulation
Active clemastine fumarate + placebo sound (white/pink noise)
Placebo drug + engineered sound stimulation
Placebo drug + placebo sound (white/pink noise)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Citations
A Treatment for a Form of Age-Related Central Auditory ...
Primary outcome is change in SNR from baseline to post-treatment (Day 30). This tests central auditory processing, not peripheral hearing, as it ...
2.
ctv.veeva.com
ctv.veeva.com/study/a-treatment-for-a-form-of-age-related-central-auditory-processing-disorder-consisting-of-clemastineA Treatment for a Form of Age-Related Central Auditory ...
The goal of this clinical trial is to determine the efficacy of Clemastine Fumarate in the presence of engineered sound to treat age-related ...
Clemastine Fumarate + Engineered Sound for Auditory ...
The trial tests if Clemastine Fumarate combined with engineered sound improves the ability to hear in noisy environments compared to placebo ...
Evaluation of Clemastine's Effects on Clinical and ...
Clemastine, combined with wrist splinting, may provide further clinical benefits in patients with CTS, particularly in improving BQ-SS and BQ-FS outcomes.
NCT02040298 | Assessment of Clemastine Fumarate as a ...
To evaluate the efficacy of Clemastine relative to placebo in reducing the EDSS score at 90 days compared to placebo (Group A) & at 150 days compared to day 90 ...
SAFETY DATA SHEET
Handle in accordance with good industrial hygiene and safety practice. Page 3 / 7. Page 4. Clemastine fumarate.
Safety Data Sheet
SOLID, N.O.S. (Clemastine (fumarate)). · IATA. Environmentally hazardous substance, solid, n.o.s.. (Clemastine (fumarate)). (Contd. on page 7).
Clemastine: Uses, Interactions, Mechanism of Action
Clemastine is an antihistamine with sedative and anticholinergic effects used to treat the symptoms of allergic rhinitis.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.