- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06942117
Investigating the Effect of Caffeine Consumption on Speech Understanding in Noise in Young Adults
April 21, 2025 updated by: Merve MERAL ÇETİNKAYA, Istanbul Aydın University
Caffeine is a widely consumed substance worldwide and is often used to increase alertness and improve cognitive functions.
Caffeine stimulates brain activity by binding to adenosine receptors, which increases alertness instead of sleepiness.
Studies on the effects of caffeine on cognitive functions have shown that it improves basic cognitive functions such as attention, reaction time, and alertness, while a less pronounced effect is seen on sensory functions such as vision and hearing.
However, no study has been found investigating the effect of caffeine consumption on understanding speech in noise.
Understanding speech in noise is a skill that includes not only auditory functions but also cognitive functions.
This skill is affected by cognitive elements such as selective attention and executive functions.
In this context, it is thought that this study, which aims to examine the relationship between caffeine and understanding speech in noise, will contribute to the literature.
60 participants between the ages of 18-30 will be included in this study.
Participants will consist of individuals without hearing loss (SSO<25 dB nHL), no history of neurological or psychological disorders, non-smokers, and those who do not use ototoxic drugs.
Participants will be randomly divided into a placebo group that consumes decaffeinated coffee and a study group that consumes coffee containing 300 mg caffeine.
The Turkish Matrix Test will be administered 30 minutes after coffee consumption.
In addition, participants will be asked to keep a caffeine diary for one week to determine their daily caffeine consumption and will be asked to fill out the Caffeine Use Disorder Scale.
Thus, they will be divided into low and high caffeine consumption groups and their speech understanding skills in noise will be compared.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Merve MERAL ÇETİNKAYA
- Phone Number: +905382835187
- Email: mervemeral1@aydin.edu.tr
Study Locations
-
-
-
Istanbul, Turkey
- Recruiting
- Istanbul Aydin University
-
Contact:
- Merve MERAL ÇETİNKAYA
- Phone Number: +905382835187
- Email: mervemeral1@aydin.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- For both groups, it was planned to include individuals who had no hearing loss (SSO<25 dB nHL), no history of neurological or psychological disorders, were non-smokers, and did not use ototoxic drugs.
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Approximately 280 grams of caffeine containing coffee is given.
|
Approximately 280 grams of caffeine containing coffee will be given
|
|
Placebo Comparator: Placebo
Decaffeinated coffee will be provided.
|
Decaffeinated coffee will be given.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Turkish Matrix Test
Time Frame: Before and 30 minutes after drinking coffee
|
The test will be administered using the Oldenburg Measurement Application (OMA) software.
Using the adaptive procedure, the signal-to-noise ratio (SNR-50) at which the individual repeats the words correctly at 50% will be found.
Accordingly, the noise will be given continuously, kept constant at 65 dB SPL throughout the test.
The test will start at 0 dB signal-to-noise ratio (SNR).
There are sentences consisting of 5 words in the test.
If the participant repeats at least three of the five words presented to him/her correctly, the SNR will decrease and if he/she does not repeat at least three words correctly, the SNR will increase.
A total of 20 sentences will be presented to the participants.
|
Before and 30 minutes after drinking coffee
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caffeine Use Disorder Scale
Time Frame: Before consuming caffeine.
|
This scale, developed by Ágoston et al. (2018), consists of 10 items based on the nine criteria recommended for caffeine use disorder specified in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
The scale measures the severity of caffeine use symptoms in the last twelve months.
As the scale score increases, caffeine use disorder symptoms also increase.
Kaya et al. (2021) conducted the Turkish validity and reliability study of the scale.
The total score that can be obtained from this scale varies between 10 and 40 and there is no reverse item.
The questions are graded as "1=never, 2=sometimes, 3=often, 4=very often" and are interpreted as caffeine use disorder increases as the scale score increases.
In the reliability analysis, Cronbach alpha internal consistency coefficient was found to be 0.86, and the intraclass correlation coefficient was found to be 0.83.
|
Before consuming caffeine.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 12, 2025
Primary Completion (Estimated)
September 13, 2025
Study Completion (Estimated)
April 13, 2026
Study Registration Dates
First Submitted
April 14, 2025
First Submitted That Met QC Criteria
April 21, 2025
First Posted (Actual)
April 24, 2025
Study Record Updates
Last Update Posted (Actual)
April 24, 2025
Last Update Submitted That Met QC Criteria
April 21, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 41/2025
- 1919B012442147 (Other Grant/Funding Number: The Scientific and Technological Research Council of Türkiye (TÜBİTAK))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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