NCT06942117

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2026

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

April 14, 2025

Last Update Submit

April 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Turkish Matrix Test

    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 Outcomes (1)

  • Caffeine Use Disorder Scale

    Before consuming caffeine.

Study Arms (2)

Experimental

EXPERIMENTAL

Approximately 280 grams of caffeine containing coffee is given.

Other: Experimental

Placebo

PLACEBO COMPARATOR

Decaffeinated coffee will be provided.

Other: Placebo

Interventions

Approximately 280 grams of caffeine containing coffee will be given

Experimental
PlaceboOTHER

Decaffeinated coffee will be given.

Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Aydin University

Istanbul, Istanbul, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Merve MERAL ÇETİNKAYA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 14, 2025

First Posted

April 24, 2025

Study Start

April 12, 2025

Primary Completion

September 13, 2025

Study Completion

April 13, 2026

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations