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The Effects of Weight Loss on Tinnitus Symptoms

Primary Purpose

Subjective Tinnitus, Obesity

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

diet and physical activity intervention

About this trial

This is an interventional treatment trial for Subjective Tinnitus focused on measuring tinnitus, diet, physical activity

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

obese

Exclusion Criteria:

diagnosed with tinnitus

Sites / Locations

Ümüş Özbey

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

diet+physical activity

diet

physical activity

control

Arm Description

diet+physical activity

diet

physical activity

control

Outcomes

Primary Outcome Measures

Weight Loss

BMI (kilogram/ metre2 (kg/m2))

Tinnitus Severity

Desibel (dB)

Tinnitus Frequency

Heartz (hz)

Secondary Outcome Measures

Visual Analog Scale (VAS) Score

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

Quality of Life Score

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

Full Information

NCT ID

NCT05265949

First Posted

December 13, 2021

Last Updated

July 19, 2023

Sponsor

Ankara University

1. Study Identification

Unique Protocol Identification Number

NCT05265949

Brief Title

The Effects of Weight Loss on Tinnitus Symptoms

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

April 23, 2019 (Actual)

Primary Completion Date

February 12, 2021 (Actual)

Study Completion Date

September 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ankara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Subjective Tinnitus, Obesity

Keywords

tinnitus, diet, physical activity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

diet+physical activity

Arm Type

Experimental

Arm Description

diet+physical activity

Arm Title

diet

Arm Type

Experimental

Arm Description

diet

Arm Title

physical activity

Arm Type

Experimental

Arm Description

physical activity

Arm Title

control

Arm Type

No Intervention

Arm Description

control

Intervention Type

Behavioral

Intervention Name(s)

diet and physical activity intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Weight Loss

Description

BMI (kilogram/ metre2 (kg/m2))

Time Frame

At the end of the 3 months

Title

Tinnitus Severity

Description

Desibel (dB)

Time Frame

At the end of the 3 months

Title

Tinnitus Frequency

Description

Heartz (hz)

Time Frame

At the end of the 3 months

Secondary Outcome Measure Information:

Title

Visual Analog Scale (VAS) Score

Description

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

Time Frame

At the end of the 3 months

Title

Quality of Life Score

Description

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

Time Frame

At the end of the 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: obese Exclusion Criteria: diagnosed with tinnitus

Facility Information:

Facility Name

Ümüş Özbey

City

Ankara

ZIP/Postal Code

06000

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

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The Effects of Weight Loss on Tinnitus Symptoms

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