Using Nicotine to Reverse Age-related Auditory Processing Deficits
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of California, Irvine
About this trial
The present study will evaluate the effects of both aging and nicotine on psychophysical tasks and electrophysiological measures. Nicotine will be administered to study participants in the form of gum that is available as an over-the-counter medication. The hypothesis is that nicotine will reverse the detrimental effects of aging on auditory processing. The proposed experiments will characterize the effects of nicotine and may eventually lead to improved treatments of hearing loss in a variety of patient populations and in healthy aging.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
between 18 and 85 years of age
non-smokers with a score of 0-2 out of 10 maximum on the Fagerström index of smoking dependency
cognitive performance within two standard deviations of the CERAD mean
Disqualifiers
less than 18 or greater than 85 years of age
deafness or excessive hearing loss
smokers with a score between 3 and 10 on the Fagerström index of smoking dependency
history of psychiatric illness, neurological disorders, diabetes mellitus, renal failure, or cardiovascular disease
Trial design
Design model
Crossover
Treatments tested in this trial
Nicotine gum
Other interventionNicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication
Placebo gum
Other interventionThe placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Nicotine gumExperimental treatment 1 intervention
Group B: Placebo gumPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hearing thresholds
Hearing thresholds in dB SPL will be measured as a function of sound frequency from 125 Hz to 8000 Hz in quiet or in noise.
Time frame
1 hour2
Modulation detection
Amplitude-modulated sounds will be presented at 70 dB SPL or a comfortable level. The detection threshold in percent modulation depth (m= 0 to 100) will be recorded and converted into signal-to-noise ratios in dB (=20log(m)).
Time frame
1 hour3
Envelope following responses
Electrophysiological responses will be recorded in response to amplitude or frequency-modulated sounds. The sounds will be presented at 70 dB SPL or a comfortable level. The EEG signal strength that is in synchrony with the modulation frequency in micro-Volts will be recorded.
Time frame
2 hoursSecondary outcomes
1
Heart rate
Pulse rate in pulses per minute will be measured via pulse oximetry.
Time frame
10 minutes2
Mood change
Mood change will be measured by a 9-category rating scale including: energy, contentedness, focus, relaxation, calmness, alertness, hunger etc.
Time frame
10 minutes3
Nicotine side effects
Side effects will be rated on a 5-point scale including: 1 = none (no symptoms at all); 2 = mild (slight jitters); 3 = moderate (jittery, slight dull headache); 4 = moderately severe (jittery, dull headache, mild nausea); 5 = severe (jittery, dull or pounding headache, nausea, vomiting).
Time frame
10 minutesOther outcomes
1
Cognition
Word learning, recall and animal fluency tests from the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) will be measured and normalized to the national standard distribution, with a score of 0 equaling to the mean and 1 being one standard deviation above the mean performance.
Time frame
1 hourSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Irvine
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov