The Effects of Weight Loss on Tinnitus Symptoms

NCT05265949 | Completed

• 1 other identifier: AnkaraUniv
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Subjective Tinnitus; Obesity

Keywords

tinnitus; diet; physical activity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Visual Analog Scale (VAS) Score

  At the end of the 3 months

• Quality of Life Score

  At the end of the 3 months

Study Arms (4)

diet+physical activity

EXPERIMENTAL

diet+physical activity

Behavioral: diet and physical activity intervention

diet

EXPERIMENTAL

diet

Behavioral: diet and physical activity intervention

physical activity

EXPERIMENTAL

physical activity

Behavioral: diet and physical activity intervention

control

NO INTERVENTION

control

Interventions

diet and physical activity intervention BEHAVIORAL

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

diet; diet+physical activity; physical activity

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• obese

You may not qualify if:

• diagnosed with tinnitus

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ümüş Özbey

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tinnitus; Obesity; Motor Activity

Interventions

Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher of the Ankara University Audiology Department

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: March 4, 2022
• Study Start: April 23, 2019
• Primary Completion: February 12, 2021
• Study Completion: September 23, 2021
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)