The Effects of Weight Loss on Tinnitus Symptoms

July 19, 2023 updated by: ümüş özbey yücel, Ankara University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06000
        • Ümüş Özbey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • obese

Exclusion Criteria:

  • diagnosed with tinnitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the end of the 3 months
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
At the end of the 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2019

Primary Completion (Actual)

February 12, 2021

Study Completion (Actual)

September 23, 2021

Study Registration Dates

First Submitted

December 13, 2021

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 4, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraUniv

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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