NCT06702085

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

November 19, 2024

Last Update Submit

November 20, 2024

Conditions

TinnitusMetabolic Syndrome XObesityElderlyWeight Loss

Outcome Measures

Primary Outcomes (1)

  • visual analogue scale of tinnitus severity

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

    twelve weeks

Secondary Outcomes (9)

  • visual analogue scale of tinnitus related discomfort

    twelve weeks

  • tinnitus handicap inventory

    twelve weeks

  • body mass index

    twelve weeks

  • waist circumference

    twelve weeks

  • triglycerides

    twelve weeks

  • +4 more secondary outcomes

Study Arms (2)

first group

EXPERIMENTAL

thirty older adults (with obesity, metabolic syndrome, and chronic subjective tinnitus) 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

Behavioral: Lifestyle Management

second group

NO INTERVENTION

thirty older adults (with obesity, metabolic syndrome, and chronic subjective tinnitus) served as control patients who did not receive any changes in their lifestyle

Interventions

Lifestyle ManagementBEHAVIORAL

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

first group

Eligibility Criteria

Age65 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-identified gender identity
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo University

Dokki, Giza Governorate, 11432, Egypt

RECRUITING

faculty of physical therapy Cairo university

Dokki, Giza Governorate, 11432, Egypt

RECRUITING

Related Publications (1)

  • Ismail AMA, Tolba AMN. Effectiveness of lifestyle-modification approach (a randomized-controlled program of diet restriction and treadmill walking exercise) on elderly's metabolic syndrome-associated subjective tinnitus. Eur Arch Otorhinolaryngol. 2025 Aug;282(8):4307-4315. doi: 10.1007/s00405-025-09494-7. Epub 2025 Jun 11.

    PMID: 40500514DERIVED

MeSH Terms

Conditions

TinnitusMetabolic SyndromeObesityWeight Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightBody Weight Changes

Study Officials

  • Ali MA Ismail, Lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, Lecturer

CONTACT

+201005154209ali.mohamed@pt.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer, Department of Physical Therapy for Cardiovascular/Respiratory Disorders and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

November 19, 2024

First Posted

November 22, 2024

Study Start

January 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

November 22, 2024

Record last verified: 2024-11

Locations

EG(2)