Chronic Subjective TinnitusNCT07665385
Trial of Management of Chronic Tinnitus by Sound Therapy and Cognitive Behavioral Therapy
A study testing Group A: sound therapy, Group B: Cognitive Behavioral Therapy and Group C: Combined CBT + Sound Therapy in people with Chronic Subjective Tinnitus, run by Sohag University at 1 site in Egypt.
Trial summary
clinical trial: The main aim of this study is to compare the effectiveness of Cognitive Behavioral Therapy (CBT) and Sound Therapy, both individually and in combination, in the management of patients with chronic subjective tinnitus and to evaluate their impact on decreasing tinnitus severity, psychological wellbeing… Read more about this study
- Who is it for?
- Ages 18 to 65 months
- Conditions the study is for
- Chronic Subjective Tinnitus
- What is being tested?
- Group A: sound therapy, Group B: Cognitive Behavioral Therapy and Group C: Combined CBT + Sound Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2026to 10 Dec 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 65 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- o Age: 18-65 years.
- Hearing level: Patients with normal hearing or mild to moderate sensorineural hearing loss (to ensure homogeneity of the sample) (National Institute for Health and Care Excellence, 2020)
- Complaint: patients with chronic subjective tinnitus (> 3 months).
- Psychological state: Patients with stable general and psychological condition.
Who cannot join
- o Age: <18, >65 years
- Hearing level: Patients with severe hearing loss not suitable for sound therapy
- Complaint: Objective tinnitus (vascular or muscular origin)
- Psychological state: Patients with active psychiatric disorders requiring immediate intervention.
- Active middle or external ear disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag faculty of medicine
Sohag
Aya Ahmed Elsayed Abdelaal, Resident doctor, 01147206609, princess.aya1297@gmail.com
About this study
Official title: Efficacy of Sound Therapy, Cognitive Behavioral Therapy and Their Combination in Management of Chronic Tinnitus
clinical trial: The main aim of this study is to compare the effectiveness of Cognitive Behavioral Therapy (CBT) and Sound Therapy, both individually and in combination, in the management of patients with chronic subjective tinnitus and to evaluate their impact on decreasing tinnitus severity, psychological wellbeing and quality of life.
Patients will be randomly divided into three groups:
- Group A: patients will receive Sound Therapy.
- Group B: patients will receive Cognitive Behavioral Therapy (CBT).
- Group C: patients will receive Combined CBT + Sound Therapy.
Read the detailed description
Because of the multifactorial nature of tinnitus, its effective management requires a multidisciplinary approach. While there is no single pullet mechanism of cure, current treatment strategies primary focus on reducing tinnitus related perception and minimizing its associated distress through auditory and psychological interventions.
Among these approaches, is the Sound Therapy which aims to decrease the contrast between tinnitus and related neural activity by introducing external sounds, which facilitates habituation and reducing tinnitus perception .
In contrast, Cognitive Behavioral Therapy (CBT) targets the patient's cognitive and emotional reaction to tinnitus by modifying maladaptive thoughts and behaviors, there by improving coping strategies and reducing tinnitus-related distress (Andersson, 2011). Recent evidence suggests that combining both modalities may provide superior outcomes compared to either approach alone, highlighting the potential value for integrated treatment strategies in tinnitus management (Hall et
- Conditions
- Chronic Subjective Tinnitus
- Being tested
- Group A: sound therapy, Group B: Cognitive Behavioral Therapy, Group C: Combined CBT + Sound Therapy
- Keywords
- Sound Therapy, Cognitive Behavioral Therapy, Chronic Tinnitus, Subjective Tinnitus, Tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: sound therapyBehavioural
Group A: Sound Therapy
- Patients will receive individualized sound therapy using broadband noise or tinnitus maskers.
- Daily use recommended for 2-4 hours/day.
- Duration: 6 weeks.
- Patient will be instructed on habituation-based listening techniques
Group B: Cognitive Behavioral TherapyBehavioural
Group B: Cognitive Behavioral Therapy (CBT)
- Structured CBT program consisting of 6 sessions over 6 weeks.
Each session categorization:
- Psychoeducation about tinnitus
- Cognitive restructuring of negative thoughts
- Relaxation techniques (breathing exercises, muscle relaxation)
- Attention diversion strategies
- Sleep hygiene education
Group C: Combined CBT + Sound TherapyBehavioural
Group C: Combined Therapy
- Patients will receive both sound therapy and CBT simultaneously following the same protocol as above.
| Study group | Role | What they receive |
|---|---|---|
| Group A: patients will receive Sound Therapy | Active comparator | Not described Receives: Behavioral: Group A: sound therapy |
| Group B: patients will receive Cognitive Behavioral Therapy (CBT). | Active comparator | Not described Receives: Behavioral: Group B: Cognitive Behavioral Therapy |
| Group C: patients will receive Combined CBT + Sound Therapy. | Active comparator | Not described Receives: Behavioral: Group A: sound therapy; Behavioral: Group B: Cognitive Behavioral Therapy; Behavioral: Group C: Combined CBT + Sound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: Changes in tinnitus severity
Assessment of tinnitus severity using the Tinnitus Functional Index (TFI) . Higher scores indicate greater tinnitus severity. the TFI total score ranges from 0 to 100, with higher score s indicating greater tinnitus severity and functional impact
Measured: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
Secondary outcomes (2)
chang in Visual Analog Scale (VAS) score
Assessment of tinnitus severity using the Visual Analog Scale (VAS) . the VAS score ranges from 0 to 10, with 0 indicate no tinnitus and 10 indicates the worst imaginable tinnitus. higher scores indicating greater tinnitus severity
Measured: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
change in Tinnitus Handicap Inventory (THI) score
Assessment of tinnitus-related handicap and quality of life using Tinnitus Handicap Inventory (THI). the THI total score ranges from 0 to 100, with higher scores indicating greater tinnitus-related handicap and poorer quality of life.
Measured: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start10 Jun 2026 (estimated)
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subjective TinnitusStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ahmed Elsayed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665385
- Sponsor's protocol ID
- Soh-Med-26-5-8MS
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No decision has been made regarding the sharing of individual participant data at this time
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sound Therapy, Cognitive Behavioral Therapy and Their Combination in Management of Chronic Tinnitus
- ClinicalTrials.gov ID
- NCT07665385
- Acronym / sponsor ID
- Soh-Med-26-5-8MS
- Conditions
- Chronic Subjective Tinnitus
- Keywords
- Sound Therapy, Cognitive Behavioral Therapy, Chronic Tinnitus, Subjective Tinnitus, Tinnitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 24 Jun 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.
clinical trial: The main aim of this study is to compare the effectiveness of Cognitive Behavioral Therapy (CBT) and Sound Therapy, both individually and in combination, in the management of patients with chronic subjective tinnitus and to evaluate their impact on decreasing tinnitus severity, psychological wellbeing and quality of life.
Patients will be randomly divided into three groups:
- Group A: patients will receive Sound Therapy.
- Group B: patients will receive Cognitive Behavioral Therapy (CBT).
- Group C: patients will receive Combined CBT + Sound Therapy.
Detailed description
Because of the multifactorial nature of tinnitus, its effective management requires a multidisciplinary approach. While there is no single pullet mechanism of cure, current treatment strategies primary focus on reducing tinnitus related perception and minimizing its associated distress through auditory and psychological interventions.
Among these approaches, is the Sound Therapy which aims to decrease the contrast between tinnitus and related neural activity by introducing external sounds, which facilitates habituation and reducing tinnitus perception .
In contrast, Cognitive Behavioral Therapy (CBT) targets the patient's cognitive and emotional reaction to tinnitus by modifying maladaptive thoughts and behaviors, there by improving coping strategies and reducing tinnitus-related distress (Andersson, 2011). Recent evidence suggests that combining both modalities may provide superior outcomes compared to either approach alone, highlighting the potential value for integrated treatment strategies in tinnitus management (Hall et
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Group A: patients will receive Sound Therapy | Active comparator | Behavioral: Group A: sound therapy |
| Group B: patients will receive Cognitive Behavioral Therapy (CBT). | Active comparator | Behavioral: Group B: Cognitive Behavioral Therapy |
| Group C: patients will receive Combined CBT + Sound Therapy. | Active comparator | Behavioral: Group A: sound therapy, Behavioral: Group B: Cognitive Behavioral Therapy, Behavioral: Group C: Combined CBT + Sound Therapy |
Who may qualify
- Ages
- 18 to 65 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- o Age: 18-65 years.
Key exclusion criteria (5 listed)
- o Age: <18, >65 years
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 |
|---|---|---|
| Group A: sound therapyGroup A: Sound Therapy * Patients will receive individualized sound therapy using broadband noise or tinnitus maskers. * Daily use recommended for 2-4 hours/day. * Duration: 6 weeks. * Patient will be instructed on habituation-based listening techniques | Behavioural | Group A: patients will receive Sound Therapy, Group C: patients will receive Combined CBT + Sound Therapy. |
| Group B: Cognitive Behavioral TherapyGroup B: Cognitive Behavioral Therapy (CBT) • Structured CBT program consisting of 6 sessions over 6 weeks. Each session categorization: * Psychoeducation about tinnitus * Cognitive restructuring of negative thoughts * Relaxation techniques (breathing exercises, muscle relaxation) * Attention diversion strategies * Sleep hygiene education | Behavioural | Group B: patients will receive Cognitive Behavioral Therapy (CBT)., Group C: patients will receive Combined CBT + Sound Therapy. |
| Group C: Combined CBT + Sound TherapyGroup C: Combined Therapy • Patients will receive both sound therapy and CBT simultaneously following the same protocol as above. | Behavioural | Group C: patients will receive Combined CBT + Sound Therapy. |
Primary outcome
Primary outcome: Changes in tinnitus severity
Time frame: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
Assessment of tinnitus severity using the Tinnitus Functional Index (TFI) . Higher scores indicate greater tinnitus severity. the TFI total score ranges from 0 to 100, with higher score s indicating greater tinnitus severity and functional impact
2 secondary outcomes
chang in Visual Analog Scale (VAS) score
Time frame: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
change in Tinnitus Handicap Inventory (THI) score
Time frame: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
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 30 Jun 2026.
- Individual participant dataSharing planned: Undecided. No decision has been made regarding the sharing of individual participant data at this time
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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 Group A: sound therapy, Group B: Cognitive Behavioral Therapy and Group C: Combined CBT + Sound Therapy in people with Chronic Subjective Tinnitus, run by Sohag University at 1 site in Egypt.
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 4 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: opening soon, as of the sponsor's last update on 30 Jun 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 Egypt. 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?
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 Aya Ahmed Elsayed Abdelaal, Resident doctor (01147206609, princess.aya1297@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: Changes in tinnitus severity (time frame: Baseline, immediately after completion of treatment , and 3 months after completion of treatment). 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 30 Jun 2026.