Subjective TinnitusNCT05265949
The Effects of Weight Loss on Tinnitus Symptoms
A study testing diet and physical activity intervention in people with Subjective Tinnitus and Obesity, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Subjective tinnitus is the perception of irregular sound at different frequencies. Although the underlying cause of tinnitus is unclear, increased body weight is known to increase tinnitus symptoms. This study aimed to determine the effects of dietary and physical activity interventions on tinnitus symptoms. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Subjective Tinnitus, Obesity
- What is being tested?
- diet and physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Apr 2019to 23 Sep 2021
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obese
Who cannot join
- diagnosed with tinnitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Dietary and Physical Activity Interventions on Tinnitus Symptoms: An RCT
Subjective tinnitus is the perception of irregular sound at different frequencies. Although the underlying cause of tinnitus is unclear, increased body weight is known to increase tinnitus symptoms. This study aimed to determine the effects of dietary and physical activity interventions on tinnitus symptoms. Sixty-three obese subjects with tinnitus aged 20 to 65 years were divided into diet + physical 8 activity (P.A.), diet, P.A., and control groups. Dietary and anthropometric records, Tinnitus Handicap 9Inventory (THI), Beck Depression Inventory (BDI), Short-Form Health Survey (SF-36), and Visual Analogue Scale (VAS) of all individuals were compared at the baseline and at the end of the study.
Read the detailed description
Although the underlying cause of tinnitus is unclear, increased body weight is known to increase tinnitus symptoms. The present study aimed to determine the effects of dietary and physical activity interventions on tinnitus symptoms.
Sixty-three obese subjects with tinnitus aged 20 to 65 years were divided into diet + physical activity (P.A.) (n = 15), diet (n = 16), P.A. (n = 15), and control (n = 17) groups. Dietary records, anthropometric measurements, Tinnitus Handicap Inventory (THI), Beck Depression Inventory (BDI), Short-Form Health Survey (SF-36), and Visual Analogue Scale (VAS) of all individuals were recorded and compared at the baseline and at study completion.
- Conditions
- Subjective Tinnitus, Obesity
- Being tested
- diet and physical activity intervention
- Keywords
- tinnitus, diet, physical activity
- Medical subject headings
- Tinnitus, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet and physical activity interventionBehavioural
Dietary intervention: Preparation and follow-up of diet program Physical activity intervention: Step count monitoring
| Study group | Role | What they receive |
|---|---|---|
| diet+physical activity | Experimental | diet+physical activity Receives: Behavioral: diet and physical activity intervention |
| diet | Experimental | diet Receives: Behavioral: diet and physical activity intervention |
| physical activity | Experimental | physical activity Receives: Behavioral: diet and physical activity intervention |
| control | No intervention | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
BMI (kilogram/ metre2 (kg/m2))
Measured: At the end of the 3 months
Tinnitus Severity
Desibel (dB)
Measured: At the end of the 3 months
Tinnitus Frequency
Heartz (hz)
Measured: At the end of the 3 months
Secondary outcomes (2)
Visual Analog Scale (VAS) Score
The score ranges from 1 to 10 points, with increasing score reflecting more discomfort
Measured: At the end of the 3 months
Quality of Life Score
The score ranges from 0 to 100 points, with an increased score reflecting improved quality of life
Measured: At the end of the 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start23 Apr 2019
- Primary completion12 Feb 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective TinnitusStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ümüş özbey yücel, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265949
- Sponsor's protocol ID
- AnkaraUniv
- Status last verified
- Jul 2023
- First submitted
- 13 Dec 2021
- Last updated
- 20 Jul 2023
- 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 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dietary and Physical Activity Interventions on Tinnitus Symptoms: An RCT
- ClinicalTrials.gov ID
- NCT05265949
- Acronym / sponsor ID
- AnkaraUniv
- Conditions
- Subjective Tinnitus, Obesity
- Keywords
- tinnitus, diet, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 4 Mar 2022 (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.
Subjective tinnitus is the perception of irregular sound at different frequencies. Although the underlying cause of tinnitus is unclear, increased body weight is known to increase tinnitus symptoms. This study aimed to determine the effects of dietary and physical activity interventions on tinnitus symptoms. Sixty-three obese subjects with tinnitus aged 20 to 65 years were divided into diet + physical 8 activity (P.A.), diet, P.A., and control groups. Dietary and anthropometric records, Tinnitus Handicap 9Inventory (THI), Beck Depression Inventory (BDI), Short-Form Health Survey (SF-36), and Visual Analogue Scale (VAS) of all individuals were compared at the baseline and at the end of the study.
Detailed description
Although the underlying cause of tinnitus is unclear, increased body weight is known to increase tinnitus symptoms. The present study aimed to determine the effects of dietary and physical activity interventions on tinnitus symptoms.
Sixty-three obese subjects with tinnitus aged 20 to 65 years were divided into diet + physical activity (P.A.) (n = 15), diet (n = 16), P.A. (n = 15), and control (n = 17) groups. Dietary records, anthropometric measurements, Tinnitus Handicap Inventory (THI), Beck Depression Inventory (BDI), Short-Form Health Survey (SF-36), and Visual Analogue Scale (VAS) of all individuals were recorded and compared at the baseline and at study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| diet+physical activity | Experimental | Behavioral: diet and physical activity interventiondiet+physical activity |
| diet | Experimental | Behavioral: diet and physical activity interventiondiet |
| physical activity | Experimental | Behavioral: diet and physical activity interventionphysical activity |
| control | No intervention | –control |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- obese
Key exclusion criteria (1 listed)
- diagnosed with tinnitus
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 |
|---|---|---|
| diet and physical activity interventionDietary intervention: Preparation and follow-up of diet program Physical activity intervention: Step count monitoring | Behavioural | diet, diet+physical activity, physical activity |
Primary outcome
Weight Loss
Time frame: At the end of the 3 months
BMI (kilogram/ metre2 (kg/m2))
Tinnitus Severity
Time frame: At the end of the 3 months
Desibel (dB)
Tinnitus Frequency
Time frame: At the end of the 3 months
Heartz (hz)
2 secondary outcomes
Visual Analog Scale (VAS) Score
Time frame: At the end of the 3 months
Quality of Life Score
Time frame: At the end of the 3 months
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 20 Jul 2023.
- 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 diet and physical activity intervention in people with Subjective Tinnitus and Obesity, run by Ankara 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 1 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 20 Jul 2023. 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?
Weight Loss (time frame: At the end of the 3 months). The study lists 3 primary outcomes in all. 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 20 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.