- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05265949
The Effects of Weight Loss on Tinnitus Symptoms
The Effects of Dietary and Physical Activity Interventions on Tinnitus Symptoms: An RCT
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06000
- Ümüş Özbey
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- obese
Exclusion Criteria:
- diagnosed with tinnitus
Study Plan
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
|
Dietary intervention: Preparation and follow-up of diet program Physical activity intervention: Step count monitoring
|
Experimental: diet
|
Dietary intervention: Preparation and follow-up of diet program Physical activity intervention: Step count monitoring
|
Experimental: physical activity
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on diet and physical activity intervention
-
Institut Català d'OncologiaUnknownRecurrence | Breast NeoplasmsSpain
-
University College of AntwerpUnknownObesity | OverweightBelgium
-
Centre for Addiction and Mental HealthPublic Health Agency of Canada (PHAC); Medical Psychiatry AllianceCompletedSmoking Cessation | Physical Activity | Fruits and Vegetable ConsumptionCanada
-
University of OsloThe Research Council of Norway; European CommissionCompletedMetabolic Syndrome | Type 2 DiabetesNorway
-
Berkeley Analytics, Inc.CompletedObesity | Cardiovascular Disease | Diabetes | AgingUnited States
-
University of California, DavisCompletedOverweight and ObesityUnited States
-
University of California, DavisNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Centro di Riferimento per l'Epidemiologia e la...Azienda Sanitaria Locale Torino 1CompletedBreast Cancer | Colorectal Cancer | Lifestyle Risk Reduction | Weight Changes, BodyItaly
-
Iberoamerican Institute of Sports Science and Human...University of Guadalajara; Mexican National Institute of Public Health; Instituto...CompletedSedentary Behavior | Child Obesity | Adipose TissueMexico
-
University of PittsburghCompletedObesity | Physical Inactivity | Functional DisabilityUnited States