TinnitusNCT06702085
Lifestyle Changes in Older Adults With Metabolic Syndrome and Tinnitus
A study testing Lifestyle Management in people with Tinnitus and Metabolic Syndrome X, run by Cairo University at 2 sites in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Tinnitus, Metabolic Syndrome X, Obesity
- What is being tested?
- Lifestyle Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- respiratory insult
- cardiac insult
- liver insult
- kidney insult
- lower limb insult
- neurological insult
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Cairo University
Dokki, Giza Governorate, 11432
ali AM Ismail, lecturer, +201005154209, ali.mohamed@pt.cu.edu.eg
ahmed MN Tolba, lecturer, +2001001897666, ali.mohamed@pt.cu.edu.eg
- Recruiting
faculty of physical therapy Cairo university
Dokki, Giza Governorate, 11432
Ali MA Ismail, lecturer, +201005154209, ali.mohamed@pt.cu.edu.eg
ahmed MN Tolba, lecturer, +201001897666 ext. +201001897666, ahmednasr6080@yahoo.com
About this study
Official title: Effects of Lifestyle Changes on Tinnitus in Older Adults With Metabolic Syndrome
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
Read the detailed description
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
- Conditions
- Tinnitus, Metabolic Syndrome X, Obesity, Elderly, Weight Loss
- Being tested
- Lifestyle Management
- Medical subject headings
- Tinnitus, Metabolic Syndrome, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ManagementBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale of tinnitus severity
it is scale (10 cm) that will assess severity of tinnitus
Measured: twelve weeks
Secondary outcomes (9)
visual analogue scale of tinnitus related discomfort
it is a scale (10 cm) that will assess tinnitus related discomfort
Measured: twelve weeks
tinnitus handicap inventory
it is a questionnaire that will assess quality of life in tinnitus population
Measured: twelve weeks
body mass index
it will be assessed at morning after evacuation of bowel and bladder
Measured: twelve weeks
waist circumference
it will be measured at the level of umbilicus
Measured: twelve weeks
triglycerides
it will be measured in the serum
Measured: twelve weeks
high density lipoprotein
it will be assessed in the serum
Measured: twelve weeks
systolic blood pressure
it will be assessed by mercury sphygmomnameter
Measured: twelve weeks
diastolic blood pressure
it will be assessed by mercury sphygmomnameter
Measured: twelve weeks
fasting blood glucose
it will be measured in serum
Measured: twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali MA Ismail, Lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702085
- Sponsor's protocol ID
- P.T.REC/012/004623
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40500514
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lifestyle Changes on Tinnitus in Older Adults With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT06702085
- Acronym / sponsor ID
- P.T.REC/012/004623
- Conditions
- Tinnitus, Metabolic Syndrome X, Obesity, Elderly, Weight Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first group | Experimental | Behavioral: Lifestyle Managementthirty 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 |
| 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 |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- respiratory insult
- cardiac insult
- liver insult
- kidney insult
- lower limb insult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Managementpatients 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 | Behavioural | first group |
Primary outcome
visual analogue scale of tinnitus severity
Time frame: twelve weeks
it is scale (10 cm) that will assess severity of tinnitus
9 secondary outcomes
visual analogue scale of tinnitus related discomfort
Time frame: twelve weeks
tinnitus handicap inventory
Time frame: twelve weeks
body mass index
Time frame: twelve weeks
waist circumference
Time frame: twelve weeks
triglycerides
Time frame: twelve weeks
high density lipoprotein
Time frame: twelve weeks
systolic blood pressure
Time frame: twelve weeks
diastolic blood pressure
Time frame: twelve weeks
fasting blood glucose
Time frame: twelve weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Derived from this study: PubMed 40500514Ismail 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali MA Ismail, Lecturer principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Management in people with Tinnitus and Metabolic Syndrome X, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Ismail, Lecturer (+201005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale of tinnitus severity (time frame: twelve weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06702085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.