Hearing and Speech Lab
Irvine, California, 92697, United States
Location status: Recruiting
NCT Number: NCT04971954
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Irvine, California, 92697, United States
Location status: Recruiting
Study participants will be recruited in two age groups: young (18-28 years) and old (60-85). Each participant will participate in two psychophysical and electrophysiological test sessions. For each of the two sessions, the participant will be administered gum before the test. For one of these sessions, the gum will be polacrilex that contains 6-mg nicotine, and for the other session, the gum will be a placebo control. The study will be double-blind, meaning that neither the experimenter nor the participant will know whether the participant has received nicotine or placebo for a given session. The study has a cross-over design, meaning that all participants will receive both nicotine and placebo in separate sessions. Finally, the order of drug administration will be counterbalanced, meaning that equal numbers of participants will receive 1) nicotine in session one and placebo in session two, and 2) placebo in session one and nicotine in session two.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication
The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.
Time frame: 1 hour
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 hour
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: 2 hours
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: 10 minutes
Pulse rate in pulses per minute will be measured via pulse oximetry.
Time frame: 10 minutes
Mood change will be measured by a 9-category rating scale including: energy, contentedness, focus, relaxation, calmness, alertness, hunger etc.
Time frame: 10 minutes
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: 1 hour
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.
Contact information is provided by the study sponsor or research team.
University of California, Irvine
Other
Using Nicotine to Reverse Age-related Auditory Processing Deficits: Human Psychophysics and Electrophysiology
Acronym: Nicotine
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07414680
Aging, Behavior
Taipei, Taiwan
View Trial DetailsNCT07099053
Aging, Alzheimer Disease
Baltimore, Maryland, United States
View Trial DetailsNCT06269939
Aging
East Hanover, New Jersey, United States
View Trial DetailsNCT07461584
Aging, Memory
Boston, Massachusetts, United States
View Trial Details