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NCT Number: NCT06702085

Lifestyle Changes in Older Adults With Metabolic Syndrome and Tinnitus

The problem of tinnitus (subjective type) is prevalent in obese older adults with different diseases such as metabolic syndrome. The changes of lifestyle are very important to lose weight, improve tinnitus and metabolic syndrome

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Key information

Conditions

Tinnitus Body Weight Body Weight Changes Ear Diseases Elderly Glucose Metabolism Disorders Hearing Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Otorhinolaryngologic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Weight Loss

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University, Dokki, Giza Governorate, Egypt

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About this study

Sixty older adults (with metabolic syndrome with chronic subjective tinnitus) with obesity were selected in a equal random manner to be classified into the first group that administered changes in their lifestyle (exercise applied on treadmill and low caloric diet) for twelve successive weeks and second group that was not administered lifestyle changes

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • obese person (class one obesity)
  • patients with metabolic syndrome
  • patients with chronic subjective tinnitus (bilateral complaint from more than six months).
  • older adults aging 65 years and more
  • both sexes will be included

Exclusion criteria

  • respiratory insult
  • cardiac insult
  • liver insult
  • kidney insult
  • lower limb insult
  • neurological insult

Treatment and study plan

Lifestyle Management

Behavioral

patients administered supervised changes in their lifestyle (walking exercise for 40 minutes applied on treadmill for three time per week and low caloric diet) for twelve weeks

Primary outcomes

  1. visual analogue scale of tinnitus severity

    Time frame: twelve weeks

    it is scale (10 cm) that will assess severity of tinnitus

Secondary outcomes

  1. visual analogue scale of tinnitus related discomfort

    Time frame: twelve weeks

    it is a scale (10 cm) that will assess tinnitus related discomfort

  2. tinnitus handicap inventory

    Time frame: twelve weeks

    it is a questionnaire that will assess quality of life in tinnitus population

  3. body mass index

    Time frame: twelve weeks

    it will be assessed at morning after evacuation of bowel and bladder

  4. waist circumference

    Time frame: twelve weeks

    it will be measured at the level of umbilicus

  5. triglycerides

    Time frame: twelve weeks

    it will be measured in the serum

  6. high density lipoprotein

    Time frame: twelve weeks

    it will be assessed in the serum

  7. systolic blood pressure

    Time frame: twelve weeks

    it will be assessed by mercury sphygmomnameter

  8. diastolic blood pressure

    Time frame: twelve weeks

    it will be assessed by mercury sphygmomnameter

  9. fasting blood glucose

    Time frame: twelve weeks

    it will be measured in serum

Study contacts

Contact information is provided by the study sponsor or research team.

Ali MA Ismail, Lecturer

CONTACT

[email protected]

+201005154209

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effects of Lifestyle Changes on Tinnitus in Older Adults With Metabolic Syndrome

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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