Tinnitus, SubjectiveNCT06803095
Efficacy of Walking Exercise With Dog on Tinnitus Complaints in Sleep Apnea (Obstructive Sleep Apnea)
A study testing free walking with dog and diet restriction and diet restriction in people with Tinnitus, Subjective and Obstructive Sleep Apnea, run by Cairo University at 1 site in Egypt.
Trial summary
there is evidence that tinnitus (chronic subjective form) is highly prevalent among patients with obstructive sleep apnea. exercise is recommneded in chronic subjective form) and obstructive sleep apnea. walking with dog increase adherence to walking to maintain continuity of physical activity Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Tinnitus, Subjective, Obstructive Sleep Apnea
- What is being tested?
- free walking with dog and diet restriction and diet restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2024to 15 May 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 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- obese persons
- bilateral chronic subjective tinnitus
- mild obstructive sleep apnea (mild apnea hypopnea index)
- forty participants
Who cannot join
- body mass index more than 40 kg/m2.
- cardiovascular problems
- hepatorenal probelms
- autoimmune problems
- orthopedic probelms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Dokki, Giza Governorate, 11432
ali AM Ismail, lecturer, +201005154209, ali.mohamed@pt.cu.edu.eg
mona abdelkhalek, PHD, +20 10 24056108, 3m.sons@gmail.com
About this study
Official title: Efficacy of Walking Exercise With Dog on Tinnitus Complaints in Sleep Apnea
there is evidence that tinnitus (chronic subjective form) is highly prevalent among patients with obstructive sleep apnea. exercise is recommneded in chronic subjective form) and obstructive sleep apnea. walking with dog increase adherence to walking to maintain continuity of physical activity
Read the detailed description
the total participants will be forty in number.. those participants will complain form tinnitus (chronic subjective form) and obstructive sleep apnea (mild degree).. the particiapnts will divided to groups.. the number of subjects in each group will be 20. The groups (both groups) will follow low calorie diet.. this diet will be applied for 12 weeks.. during this period the study group will receive free walking (30 min) with dog three timmes weekly. the control group will not receive free walking with dog
- Conditions
- Tinnitus, Subjective, Obstructive Sleep Apnea
- Being tested
- free walking with dog and diet restriction, diet restriction
- Medical subject headings
- Tinnitus, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free walking with dog and diet restrictionBehavioural
the total participants of tinnitus (chronic subjective form) and obstructive sleep apnea (mild degree) in this group will be 20. This group will follow low calorie diet.. this diet will be applied for 12 weeks.. during this period the study, this group will receive free walking (30 min) with dog three timmes weekly.
diet restrictionBehavioural
the total participants with tinnitus (chronic subjective form) and obstructive sleep apnea (mild degree) in this group will be 20. This group will follow low calorie diet only .. this diet will be applied for 12 weeks..
| Study group | Role | What they receive |
|---|---|---|
| group I | Experimental | the total participants of tinnitus (chronic subjective form) and obstructive sleep apnea (mild degree) in this group will be 20. This groups will follow low calorie diet.. this diet will be applied for 12 weeks.. during this period this group will receive free walking (30 min) with dog three timmes weekly. Receives: Behavioral: free walking with dog and diet restriction |
| Group II | Active comparator | the total participants of tinnitus (chronic subjective form) and obstructive sleep apnea (mild degree) in this group will be 20. This group will follow low calorie diet only.. this diet will be applied for 12 weeks.. Receives: Behavioral: diet restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
tinnitus handicap inventory
it is a questionaire assess tinnitus-associating life quality
Measured: it will be assessed after 12 weeks
Secondary outcomes (8)
VAS of discomfort induced by tinnitus
it is 10 com visual analogue scale
Measured: it will be assessed after 12 weeks
VAS of loudness of tinnitus
it is 10 com visual analogue scale
Measured: it will be assessed after 12 weeks
apnea hyponea index
it is number of occurrences of apnea and hyponea in hour
Measured: it will be assessed after 12 weeks
Eporwth sleepiness scale
it will assess daytime sleepiness
Measured: it will be assessed after 12 weeks
Pittsburgh sleeping quality index
it will assess sleep quality (subjective assessment)
Measured: it will be assessed after 12 weeks
Questionnaire of Depression, Anxiety, Stress Scales
it will contain 42 questions assessing psychological status (Depression, Anxiety, Stress) of participants
Measured: it will be measured after 12 weeks
body mass index
it will be measured on empty stomach
Measured: it will be measured after 12 weeks
wait circumference
it will be measured at umbilical level
Measured: it will be measured after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start12 Dec 2024
- Primary completion15 May 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies 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
- 40 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 Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803095
- Sponsor's protocol ID
- IRB00014233-18
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Walking Exercise With Dog on Tinnitus Complaints in Sleep Apnea
- ClinicalTrials.gov ID
- NCT06803095
- Acronym / sponsor ID
- IRB00014233-18
- Conditions
- Tinnitus, Subjective, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 31 Jan 2025 (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.
there is evidence that tinnitus (chronic subjective form) is highly prevalent among patients with obstructive sleep apnea. exercise is recommneded in chronic subjective form) and obstructive sleep apnea. walking with dog increase adherence to walking to maintain continuity of physical activity
Detailed description
the total participants will be forty in number.. those participants will complain form tinnitus (chronic subjective form) and obstructive sleep apnea (mild degree).. the particiapnts will divided to groups.. the number of subjects in each group will be 20. The groups (both groups) will follow low calorie diet.. this diet will be applied for 12 weeks.. during this period the study group will receive free walking (30 min) with dog three timmes weekly. the control group will not receive free walking with dog
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | Experimental | Behavioral: free walking with dog and diet restrictionthe total participants of tinnitus (chronic subjective form) and obstructive sleep apnea (mild degree) in this group will be 20. This groups will follow low calorie diet.. this diet will be applied for 12 weeks.. during this period this group will receive free walking (30 min) with dog three timmes weekly. |
| Group II | Active comparator | Behavioral: diet restrictionthe total participants of tinnitus (chronic subjective form) and obstructive sleep apnea (mild degree) in this group will be 20. This group will follow low calorie diet only.. this diet will be applied for 12 weeks.. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- obese persons
- bilateral chronic subjective tinnitus
- mild obstructive sleep apnea (mild apnea hypopnea index)
- forty participants
Key exclusion criteria (5 listed)
- body mass index more than 40 kg/m2.
- cardiovascular problems
- hepatorenal probelms
- autoimmune problems
- orthopedic probelms
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 |
|---|---|---|
| free walking with dog and diet restrictionthe total participants of tinnitus (chronic subjective form) and obstructive sleep apnea (mild degree) in this group will be 20. This group will follow low calorie diet.. this diet will be applied for 12 weeks.. during this period the study, this group will receive free walking (30 min) with dog three timmes weekly. | Behavioural | group I |
| diet restrictionthe total participants with tinnitus (chronic subjective form) and obstructive sleep apnea (mild degree) in this group will be 20. This group will follow low calorie diet only .. this diet will be applied for 12 weeks.. | Behavioural | Group II |
Primary outcome
tinnitus handicap inventory
Time frame: it will be assessed after 12 weeks
it is a questionaire assess tinnitus-associating life quality
8 secondary outcomes
VAS of discomfort induced by tinnitus
Time frame: it will be assessed after 12 weeks
VAS of loudness of tinnitus
Time frame: it will be assessed after 12 weeks
apnea hyponea index
Time frame: it will be assessed after 12 weeks
Eporwth sleepiness scale
Time frame: it will be assessed after 12 weeks
Pittsburgh sleeping quality index
Time frame: it will be assessed after 12 weeks
Questionnaire of Depression, Anxiety, Stress Scales
Time frame: it will be measured after 12 weeks
body mass index
Time frame: it will be measured after 12 weeks
wait circumference
Time frame: it will be measured after 12 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 31 Jan 2025.
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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 Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing free walking with dog and diet restriction and diet restriction in people with Tinnitus, Subjective and Obstructive Sleep Apnea, run by Cairo University at 1 site 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 4 inclusion and 5 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 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Isamil, Lecturer (0201005154209, 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?
tinnitus handicap inventory (time frame: it will be assessed after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2025.