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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Istanbul Aydin University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Approximately 280 grams of caffeine containing coffee is given.
Other: Experimental
Approximately 280 grams of caffeine containing coffee will be given
Placebo Comparator: Placebo
Decaffeinated coffee will be provided.
Other: Placebo
Decaffeinated coffee will be given.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Aydın University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 13, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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