HearingNCT06942117
Investigating the Effect of Caffeine Consumption on Speech Understanding in Noise in Young Adults
A study testing Experimental in people with Hearing, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing
- What is being tested?
- Experimental
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Apr 2025to 13 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul Aydin University
Istanbul, Istanbul
Merve MERAL ÇETİNKAYA, +905382835187, mervemeral1@aydin.edu.tr
About this study
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.
- Conditions
- Hearing
- Being tested
- Experimental, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Approximately 280 grams of caffeine containing coffee will be given
PlaceboOther
Decaffeinated coffee will be given.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Approximately 280 grams of caffeine containing coffee is given. Receives: Other: Experimental |
| Placebo | Placebo comparator | Decaffeinated coffee will be provided. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and 30 minutes after drinking coffee
Secondary outcomes (1)
Caffeine Use Disorder Scale
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.
Measured: Before consuming caffeine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start12 Apr 2025
- Primary completion13 Sep 2025 (estimated)
- Study completion13 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HearingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve MERAL ÇETİNKAYA, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942117
- Sponsor's protocol ID
- 41/2025
- Other IDs
- 1919B012442147
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Caffeine Consumption on Speech Understanding in Noise in Young Adults
- ClinicalTrials.gov ID
- NCT06942117
- Acronym / sponsor ID
- 41/2025
- Conditions
- Hearing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 12 Apr 2025 (actual)
- Primary completion
- 13 Sep 2025 (estimated)
- Study completion
- 13 Apr 2026 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: ExperimentalApproximately 280 grams of caffeine containing coffee is given. |
| Placebo | Placebo comparator | Other: PlaceboDecaffeinated coffee will be provided. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalApproximately 280 grams of caffeine containing coffee will be given | Other | Experimental |
| PlaceboDecaffeinated coffee will be given. | Other | Placebo |
Primary outcome
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.
1 secondary outcome
Caffeine Use Disorder Scale
Time frame: Before consuming caffeine.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Hearing, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve MERAL ÇETİNKAYA (+905382835187, mervemeral1@aydin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turkish Matrix Test (time frame: Before and 30 minutes after drinking coffee). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.