The Effects of Weight Loss on Tinnitus Symptoms

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05265949
• Other study ID #: AnkaraUniv
• Status: Completed
• Phase: N/A
• Start date: April 23, 2019
• Est. completion date: September 23, 2021

Study information

• Verified date: July 2023
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 23, 2021
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• obese

Exclusion Criteria:

• diagnosed with tinnitus

Related Conditions & MeSH terms

• Obesity
• Subjective Tinnitus
• Tinnitus

Intervention

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

Locations

Country	Name	City	State
Turkey	Ümüs Özbey	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss	BMI (kilogram/ metre2 (kg/m2))	At the end of the 3 months
Primary	Tinnitus Severity	Desibel (dB)	At the end of the 3 months
Primary	Tinnitus Frequency	Heartz (hz)	At the end of the 3 months
Secondary	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
Secondary	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