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Clemastine Fumarate and Engineered Sound for Age-Related Central Auditory Processing Disorder

This study is testing a treatment for age-related Central Auditory Processing Disorder (CAPD), a condition that makes it hard to hear in noisy places. The treatment combines a drug called clemastine fumarate with special "engineered sound." Researchers believe this combination might help repair nerve pathways in the brain that are important for hearing. The study aims to see if this treatment, which showed promise in animal studies, can improve hearing in noisy environments for people. You might be able to join if you are between 45 and 65 years old and have mild high-frequency hearing loss. The study will measure improvements in your ability to hear in noise after about 5 to 6 weeks of treatment. The current status of the study is unclear, but it plans to enroll 344 participants.

Study design
This interventional study plans to enroll 344 participants. It compares different combinations of clemastine fumarate, engineered sound, and placebos (inactive treatments).
What's involved
Participants will take clemastine fumarate or a placebo drug for 30 days, with varying doses during the first week. The study does not specify other procedures or visits.
Compensation
Not stated in the trial record.
Follow-up
Your hearing will be re-evaluated after intervention, around Week 5 or 6, to see if there's an improvement.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07304024

A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound

Recruiting
PHASE1Ages 45–65InterventionalTreatment
University of Colorado, Denver
~344 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:Clemastine Fumarate Combined With Engineered SoundClemastine Fumarate Combined With Pink NoisePlacebo Drug With Engineered SoundPlacebo - Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improvement in hearing-in-noise at 15 degree separation
Measured over At enrollment and again after intervention (Week 5 or 6)
+1 more outcome measured

Conditions

Central Auditory Processing Disorder
Hearing Impaired (Partially)
Hearing
Hearing Abnormality
Hearing Disability
Hearing Disorder
Hearing Disorders
Hearing Impairment, Sensorineural
Hearing Handicap
Hearing Impaired
Hearing Impairment
Hearing Loss
Central Auditory Disease
Noise Exposure
Noise Induced Hearing Loss
Noise-Induced Hearing Loss
Sound Perception
Myelin Degeneration
Myelinopathy
Myelin Integrity
Remyelination
Hidden Hearing Loss
Cocktail Party Skill
Cocktail Party Syndrome
CAPD
Age Problem

Explore related trials

Central Auditory Processing Disorder

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Achim Klug, PhD · PRINCIPAL_INVESTIGATOR · Colorado University Anschutz Medical Center
  • Samuel A Budoff, PhD, MS · STUDY_DIRECTOR · Colorado University Anschutz Medical Center

Who to contact

Ajay Keerthy, BS
[email protected]
248-421-5796
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female between 45 and 65 years old (middle aged) at the screening/enrollment visit (Visit 1).
Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study.
Documentation of no more than a mild high-frequency hearing sensitivity loss and normal middle-ear function will be obtained using standard audiometric equipment with measurements done by an audiologist; Specifically, testing will show:
bilateral hearing thresholds \< 20 dB HL at audiometric frequencies from 250 Hz to 4000 Hz inclusively, with no air-bone gaps \> 10 dB.
symmetrical hearing thresholds between the ears through 8000 Hz, defined as \<20 dB difference at any single audiometric frequency or \< 15 dB difference at 2 or more contiguous frequencies.
normal (Type A) tympanograms bilaterally.
No cognitive deficit shown upon screening with the Montreal Cognitive Assessment (MOCA) test (Nasreddine et al. 2005).
Distortion product otoacoustic emission (DPOAE) showing no more than 20 dB hearing loss at audiometric frequencies from 250 Hz to 4000 Hz.
Subjects failing the hearing in noise test at 15 degrees. Failing is defined as SNR being 12 dB below from what is found in normal hearing subjects without central hearing loss.

Exclusion

Any subjects who do not fall under the criteria defined above.
Any of the following conditions which are listed as contraindications or warnings for use of the clinical trial drug (from labeling):
Known sensitivity to clemastine fumarate or other antihistamines of similar composition
Pregnancy or nursing mother as determined objectively with a urine pregnancy test
Lower respiratory tract disease including asthma, or breathing difficulties such as emphysema or chronic bronchitis
Glaucoma or increased intraocular pressure
Stenosing peptic ulcers or pyloroduodenal obstruction
Trouble urinating due to an enlarged prostate gland. Mild urinary issues (Stage 1 Benign Prostatic Hyperplasia) will not be considered an automatic exclusion but it must be emphasized to patients with this diagnosis that difficulty urinating is a possible side effect that may compound their BPH symptoms.
Significant cardiovascular disease, chronic hypertension or hypotension
Hyperthyroidism
Alcoholism- as defined by consuming on average 3+ drinks per day for women or 4+ drinks per day for men or previous diagnosis of alcohol use disorder by a clinician as defined by DSM V criteria.
Patients with a history of seizures will be excluded.
Patients with evidence of suicidal ideation/behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).
Leukopenia as defined as a CBC white blood cell count \< 4000/ul
Anemia as defined by a CBC Hemoglobin \<9.0 g/dL or \<10.0 g/dL (Grade 2+ CTCAE)
Lymphopenia as defined by CBC Absolute lymphocyte count \<1000/µL.
Thrombocytopenia as defined by CBC Platelet count \<75000/µL
Hepatic Impairment based on CMP: Total bilirubin \>1.5× ULN, AST/ALT \>3× ULN (or \>5× ULN if liver metastases), Alkaline phosphatase \>3× ULN.
Hepatic Impairment based on CMP: Serum creatinine \>2.0 mg/dL (alternative threshold).
Metabolic abnormalities based on CMP: Albumin \<3.0 g/dL
Taking medications that would contraindicate taking the clinical trial drug; Specifically, (from labeling):
Monoamine oxidase inhibitor therapy
CNS depressants (sedatives, tranquilizers, hypnotics)
A history of significant otologic disorder such as repetitive ear infections or Meniere's disease
A history of significant neurologic disorder, or current neurodegenerative diseases such as multiple sclerosis, which could present a confound and impact the electrophysiological outcome measures.
A history of traumatic brain or closed head injury because this can cause symptoms of central auditory processing problems unrelated to aging and demyelination.
English as a second language (non-native English speakers), which is known to negatively impact scores on speech recognition testing.
Presence of any other condition or abnormality that in the opinion of the Investigator or his co-PIs would compromise the safety of the patient or the quality of the data.

What this trial measures

  • Improvement in hearing-in-noise at 15 degree separationAt enrollment and again after intervention (Week 5 or 6)

    Measures ability to understand speech in background noise, tested in a sound chamber with speakers arranged in a circle. Participants listen to sentences spoken by a female speaker while 6-person babble noise plays from a speaker 15 degrees away. Test uses Harvard IEEE sentences (5 keywords each) at 60 dB with varying signal-to-noise ratios (SNR). Participants repeat words they hear. An adaptive procedure determines the SNR needed for 40% accuracy (\>2/5 words correct) and 80% accuracy (\>4/5 words correct). Lower SNR values indicate better performance. Primary outcome is change in SNR from baseline to post-treatment (Day 30). This tests central auditory processing, not peripheral hearing, as it requires the brain to separate speech from noise when sounds come from different directions. Analysis uses linear regression comparing treatment groups to placebo for change in SNR, with p\<0.017 considered significant due to multiple endpoints. Success is group-wise improvement of \>3dB.

  • Improvement in hearing-in-noise at 30 degree separationAt enrollment and again after intervention (Week 5 or 6)

    Measures ability to understand speech in background noise, tested in a sound chamber with speakers arranged in a circle. Participants listen to sentences spoken by a female speaker while 6-person babble noise plays from a speaker 30 degrees away. Test uses Harvard IEEE sentences (5 keywords each) at 60 dB with varying signal-to-noise ratios (SNR). Participants repeat words they hear. An adaptive procedure determines the SNR needed for 40% accuracy (\>2/5 words correct) and 80% accuracy (\>4/5 words correct). Lower SNR values indicate better performance. Primary outcome is change in SNR from baseline to post-treatment (Day 30). This tests central auditory processing, not peripheral hearing, as it requires the brain to separate speech from noise when sounds come from different directions. Analysis uses linear regression comparing treatment groups to placebo for change in SNR, with p\<0.017 considered significant due to multiple endpoints. Success is group-wise improvement of \>3dB.