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Completed

NCT Number: NCT05265949

The Effects of Weight Loss on Tinnitus Symptoms

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.

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Key information

Conditions

Subjective Tinnitus Behavior Body Weight Ear Diseases Hearing Disorders Motor Activity Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Otorhinolaryngologic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ümüş Özbey

Ankara, 06000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • obese

Exclusion criteria

  • diagnosed with tinnitus

Treatment and study plan

diet and physical activity intervention

Behavioral

Dietary intervention: Preparation and follow-up of diet program Physical activity intervention: Step count monitoring

Primary outcomes

  1. Weight Loss

    Time frame: At the end of the 3 months

    BMI (kilogram/ metre2 (kg/m2))

  2. Tinnitus Severity

    Time frame: At the end of the 3 months

    Desibel (dB)

  3. Tinnitus Frequency

    Time frame: At the end of the 3 months

    Heartz (hz)

Secondary outcomes

  1. Visual Analog Scale (VAS) Score

    Time frame: At the end of the 3 months

    The score ranges from 1 to 10 points, with increasing score reflecting more discomfort

  2. Quality of Life Score

    Time frame: At the end of the 3 months

    The score ranges from 0 to 100 points, with an increased score reflecting improved quality of life

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2022
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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