Chronic TinnitusNCT07324603
Smartphone-Based vs Face-to-Face Counseling for Tinnitus
A study testing Face-to-Face Tinnitus Counseling and Smartphone-Based Tinnitus Counseling in people with Chronic Tinnitus, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effectiveness of smartphone-based counseling and face-to-face counseling in adults with chronic tinnitus. Both interventions are based on the same structured counseling protocol and are delivered over a six-week period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Tinnitus
- What is being tested?
- Face-to-Face Tinnitus Counseling and Smartphone-Based Tinnitus Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 7 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Diagnosis of chronic subjective tinnitus lasting at least 6 months
- Completion of a comprehensive audiological evaluation
- Ability to read and understand the study materials
- Adequate cognitive function as determined by a Mini-Mental State Examination score of 25 or higher
- Willingness and ability to provide written informed consent
Who cannot join
- Presence of objective tinnitus
- History of neurological disorders
- Diagnosed major psychiatric disorders
- Receipt of tinnitus-related treatment within the previous 3 months
- Inability to use or access the smartphone application (for technical or device-related reasons)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Faculty of Health Sciences
Kayseri, Kayseri, 38000
About this study
Official title: A Randomized Controlled Trial Comparing Smartphone-Based and Face-to-Face Counseling for Chronic Tinnitus
This study aims to compare the effectiveness of smartphone-based counseling and face-to-face counseling in adults with chronic tinnitus. Both interventions are based on the same structured counseling protocol and are delivered over a six-week period. The primary research question is whether smartphone-based counseling can achieve clinical outcomes comparable to those of traditional face-to-face counseling in reducing tinnitus-related impact and associated symptoms.
Read the detailed description
This study is a randomized, parallel-group clinical trial designed to evaluate two counseling delivery formats for chronic tinnitus. Eligible adult participants with chronic subjective tinnitus are allocated to either smartphone-based counseling or face-to-face counseling. Both groups receive the same structured counseling content, with the delivery format being the only difference between interventions.
The counseling protocol focuses on tinnitus education, correction of maladaptive beliefs, and development of coping strategies. In the face-to-face group, counseling is delivered through scheduled in-person sessions using a structured educational booklet. In the smartphone-based group, the same content is delivered through a mobile application consisting of sequential modules, including assessment, education, coping strategies, and a clinician support feature.
Participants in both groups complete baseline assessments prior to counseling and follow-up evaluations at two and six weeks. The study is designed to examine whether smartphone-based counseling can achieve outcomes comparable to traditional face-to-face counseling when a unified counseling protocol is applied.
- Conditions
- Chronic Tinnitus
- Being tested
- Face-to-Face Tinnitus Counseling, Smartphone-Based Tinnitus Counseling
- Keywords
- Chronic tinnitus, Counseling, Smartphone-based counseling, Digital Health, Mobile Application, Patient Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-Face Tinnitus CounselingBehavioural
Structured tinnitus counseling is delivered in person using a standardized educational booklet over a six-week period.
Smartphone-Based Tinnitus CounselingBehavioural
Structured tinnitus counseling is delivered via a mobile application with sequential modules over a six-week period
| Study group | Role | What they receive |
|---|---|---|
| Face-to-Face Counseling | Experimental | Participants receive structured tinnitus counseling delivered in person using a standardized educational booklet over a six-week period. Receives: Behavioral: Face-to-Face Tinnitus Counseling |
| Smartphone-Based Counseling | Experimental | Participants receive the same structured tinnitus counseling delivered via a mobile application with sequential modules over a six-week period. Receives: Behavioral: Smartphone-Based Tinnitus Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Impact
Change in tinnitus impact assessed using the Tinnitus Handicap Inventory (THI).
Measured: Baseline to 6 weeks
Secondary outcomes (4)
Depressive Symptoms
Change in depressive symptoms assessed using the Beck Depression Inventory (BDI).
Measured: Baseline to 6 weeks
Sleep Quality
Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).
Measured: Baseline to 6 weeks
Perceived Tinnitus Severity
Change in perceived tinnitus severity assessed using a Visual Analog Scale (VAS).
Measured: Baseline to 6 weeks
Tinnitus-Related Annoyance
Change in tinnitus-related annoyance assessed using a Visual Analog Scale (VAS).
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 May 2024
- Primary completion1 Mar 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic TinnitusStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Beyza ASTA, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324603
- Sponsor's protocol ID
- İ04-201-23
- Other IDs
- 124S118
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2025
- Last updated
- 7 Jan 2026
- 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Smartphone-Based and Face-to-Face Counseling for Chronic Tinnitus
- ClinicalTrials.gov ID
- NCT07324603
- Acronym / sponsor ID
- İ04-201-23
- Conditions
- Chronic Tinnitus
- Keywords
- Chronic tinnitus, Counseling, Smartphone-based counseling, Digital Health, Mobile Application, Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 7 Jan 2026 (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.
This study aims to compare the effectiveness of smartphone-based counseling and face-to-face counseling in adults with chronic tinnitus. Both interventions are based on the same structured counseling protocol and are delivered over a six-week period. The primary research question is whether smartphone-based counseling can achieve clinical outcomes comparable to those of traditional face-to-face counseling in reducing tinnitus-related impact and associated symptoms.
Detailed description
This study is a randomized, parallel-group clinical trial designed to evaluate two counseling delivery formats for chronic tinnitus. Eligible adult participants with chronic subjective tinnitus are allocated to either smartphone-based counseling or face-to-face counseling. Both groups receive the same structured counseling content, with the delivery format being the only difference between interventions.
The counseling protocol focuses on tinnitus education, correction of maladaptive beliefs, and development of coping strategies. In the face-to-face group, counseling is delivered through scheduled in-person sessions using a structured educational booklet. In the smartphone-based group, the same content is delivered through a mobile application consisting of sequential modules, including assessment, education, coping strategies, and a clinician support feature.
Participants in both groups complete baseline assessments prior to counseling and follow-up evaluations at two and six weeks. The study is designed to examine whether smartphone-based counseling can achieve outcomes comparable to traditional face-to-face counseling when a unified counseling protocol is applied.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-to-Face Counseling | Experimental | Behavioral: Face-to-Face Tinnitus CounselingParticipants receive structured tinnitus counseling delivered in person using a standardized educational booklet over a six-week period. |
| Smartphone-Based Counseling | Experimental | Behavioral: Smartphone-Based Tinnitus CounselingParticipants receive the same structured tinnitus counseling delivered via a mobile application with sequential modules over a six-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older
- Diagnosis of chronic subjective tinnitus lasting at least 6 months
- Completion of a comprehensive audiological evaluation
- Ability to read and understand the study materials
- Adequate cognitive function as determined by a Mini-Mental State Examination score of 25 or higher
Key exclusion criteria (5 listed)
- Presence of objective tinnitus
- History of neurological disorders
- Diagnosed major psychiatric disorders
- Receipt of tinnitus-related treatment within the previous 3 months
- Inability to use or access the smartphone application (for technical or device-related reasons)
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 |
|---|---|---|
| Face-to-Face Tinnitus CounselingStructured tinnitus counseling is delivered in person using a standardized educational booklet over a six-week period. | Behavioural | Face-to-Face Counseling |
| Smartphone-Based Tinnitus CounselingStructured tinnitus counseling is delivered via a mobile application with sequential modules over a six-week period | Behavioural | Smartphone-Based Counseling |
Primary outcome
Tinnitus Impact
Time frame: Baseline to 6 weeks
Change in tinnitus impact assessed using the Tinnitus Handicap Inventory (THI).
4 secondary outcomes
Depressive Symptoms
Time frame: Baseline to 6 weeks
Sleep Quality
Time frame: Baseline to 6 weeks
Perceived Tinnitus Severity
Time frame: Baseline to 6 weeks
Tinnitus-Related Annoyance
Time frame: Baseline to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-Face Tinnitus Counseling and Smartphone-Based Tinnitus Counseling in people with Chronic Tinnitus, run by TC Erciyes 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 7 Jan 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Impact (time frame: Baseline to 6 weeks). 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 7 Jan 2026.