Efficacy of Walking Exercise With Dog on Tinnitus Complaints in Sleep Apnea (Obstructive Sleep Apnea)

January 27, 2025 updated by: Ali Mohamed Ali ismail, Cairo University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: mona abdelkhalek, Lecturer
  • Phone Number: 020 10 24056108
  • Email: 3m.sons@gmail.com

Study Locations

  • Egypt
    • Giza
      • Dokki, Giza, Egypt, 11432
        • Recruiting
        • Cairo University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • obese persons
  • bilateral chronic subjective tinnitus
  • mild obstructive sleep apnea (mild apnea hypopnea index)
  • forty participants

Exclusion Criteria:

  • body mass index more than 40 kg/m2.
  • cardiovascular problems
  • hepatorenal probelms
  • autoimmune problems
  • orthopedic probelms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group I
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.
Behavioral: free walking with dog and diet restriction
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.
Active Comparator: Group II
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..
Behavioral: diet restriction
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..

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tinnitus handicap inventory
Time Frame: it will be assessed after 12 weeks
it is a questionaire assess tinnitus-associating life quality
it will be assessed after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body mass index
Time Frame: it will be measured after 12 weeks
it will be measured on empty stomach
it will be measured after 12 weeks
VAS of discomfort induced by tinnitus
Time Frame: it will be assessed after 12 weeks
it is 10 com visual analogue scale
it will be assessed after 12 weeks
VAS of loudness of tinnitus
Time Frame: it will be assessed after 12 weeks
it is 10 com visual analogue scale
it will be assessed after 12 weeks
apnea hyponea index
Time Frame: it will be assessed after 12 weeks
it is number of occurrences of apnea and hyponea in hour
it will be assessed after 12 weeks
Eporwth sleepiness scale
Time Frame: it will be assessed after 12 weeks
it will assess daytime sleepiness
it will be assessed after 12 weeks
Pittsburgh sleeping quality index
Time Frame: it will be assessed after 12 weeks
it will assess sleep quality (subjective assessment)
it will be assessed after 12 weeks
Questionnaire of Depression, Anxiety, Stress Scales
Time Frame: it will be measured after 12 weeks
it will contain 42 questions assessing psychological status (Depression, Anxiety, Stress) of participants
it will be measured after 12 weeks
wait circumference
Time Frame: it will be measured after 12 weeks
it will be measured at umbilical level
it will be measured after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Ali Ismail, lecturer, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2024

Primary Completion (Estimated)

May 15, 2025

Study Completion (Estimated)

May 15, 2025

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00014233-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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