The Effects of Weight Loss on Tinnitus Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Dietary and Physical Activity Interventions on Tinnitus Symptoms: An RCT

Conditions
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Subjective Tinnitus, Obesity

Intervention / Treatment
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* Behavioral: diet and physical activity intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: obese Exclusion Criteria: diagnosed with tinnitus

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diet+physical activity<br>diet+physical activity | Behavioral: diet and physical activity intervention<br>* Dietary intervention: Preparation and follow-up of diet program Physical activity intervention: Step count monitoring<br>|
| Experimental: diet<br>diet | Behavioral: diet and physical activity intervention<br>* Dietary intervention: Preparation and follow-up of diet program Physical activity intervention: Step count monitoring<br>|
| Experimental: physical activity<br>physical activity | Behavioral: diet and physical activity intervention<br>* Dietary intervention: Preparation and follow-up of diet program Physical activity intervention: Step count monitoring<br>|
| No Intervention: control<br>control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | BMI (kilogram/ metre2 (kg/m2)) | At the end of the 3 months | 
| Tinnitus Severity | Desibel (dB) | At the end of the 3 months | 
| Tinnitus Frequency | Heartz (hz) | At the end of the 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Score | The score ranges from 1 to 10 points, with increasing score reflecting more discomfort | 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 | At the end of the 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tinnitus, diet, physical activity