What side effects are associated with this type of intervention?

Nicotine, used in treatments like nicotine gum, can enhance auditory processing by modulating neurotransmitter release and improving neural function. However, it also has harmful effects, such as damaging cochlear hair cells, leading to hearing loss and tinnitus. Exposure to tobacco smoke, which contains nicotine, can reduce otoacoustic emissions and vestibular evoked myogenic potentials, indicating damage to the cochlear and vestibular hair cells. These effects are often irreversible, highlighting the need to weigh potential benefits against the risks.

What prior FDA approvals exist?

There are currently no FDA-approved drugs specifically for the treatment of hearing impairment that function similarly to nicotine gum by enhancing auditory processing through neurotransmitter modulation. Most treatments for hearing impairment focus on hearing aids, cochlear implants, and addressing underlying conditions such as infections or earwax buildup. Research is ongoing in the field of auditory processing and hearing loss, with some studies exploring the potential of various compounds, including antioxidants and other neuroprotective agents, but these have not yet resulted in FDA-approved medications.

What other types of research exist?

Promising alternatives to nicotine gum for hearing impairment patients may include emerging pharmacotherapies targeting neurodevelopmental disorders, such as those enhancing neurogenesis and cognitive performance. Additionally, mindfulness interventions and stress management strategies, although primarily used for smoking cessation, may also support auditory processing by reducing stress-related barriers. Further research into specific pharmacological agents that modulate neurotransmitter release and neural function is warranted.

← Back to Search

Nicotinic Acetylcholine Receptor Agonist

Nicotine Gum for Hearing Impairment (Nicotine Trial)

N/A

Recruiting

Led By Fan-Gang Zeng, PhD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18 and 85 years

Be older than 18 years old

Must not have

Age less than 18 or greater than 85 years

History of psychiatric illness, neurological disorders, diabetes mellitus, renal failure, or cardiovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 minutes

Summary

This trial will test if chewing nicotine gum can help improve hearing in young and older adults by enhancing how the brain processes sounds. Nicotine has been commonly used in studies, showing its benefits on mental performance.

Who is the study for?

This trial is for non-smoking adults aged 18-85 with mild hearing issues and normal cognitive function. It's not for those who are deaf, have severe hearing loss, take regular prescription meds (except birth control), have a history of drug dependency or certain health conditions like heart disease or diabetes.

What is being tested?

The study tests if nicotine gum can help older adults hear better by improving how their brains process sounds. Participants will chew either nicotine gum or a placebo gum without active ingredients to see if there's any difference in their hearing abilities.

What are the potential side effects?

Nicotine gum may cause side effects such as headaches, hiccups, upset stomach, jaw discomfort from chewing, and possibly increased heart rate. Long-term effects are not well-studied but could include dependence on nicotine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am younger than 18 or older than 85.

Select...

I have a history of mental health issues, nerve disorders, diabetes, kidney failure, or heart disease.

Select...

I am deaf or have significant hearing loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Envelope following responses

Hearing thresholds

Modulation detection

Secondary study objectives

Heart rate

Mood change

Nicotine side effects

Other study objectives

Cognition

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Nicotine gumExperimental Treatment1 Intervention

Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication

Group II: Placebo gumPlacebo Group1 Intervention

The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Nicotine, as a stimulant, may enhance auditory processing by modulating neurotransmitter release and improving neural function. This mechanism is significant for hearing impairment patients because it offers a potential therapeutic approach that targets the neural pathways involved in hearing. By improving neurotransmitter function, nicotine could help mitigate auditory processing deficits, particularly those associated with age-related hearing loss.

Effect of nicotine on cochlear function and noise-induced hair cell loss.Nitroprusside suppresses cochlear potentials and outer hair cell responses.Otoacoustic emissions in neonates exposed to smoke during pregnancy.