NCT06803095

Brief 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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

January 27, 2025

Last Update Submit

January 27, 2025

Conditions

Tinnitus, SubjectiveObstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • tinnitus handicap inventory

    it is a questionaire assess tinnitus-associating life quality

    it will be assessed after 12 weeks

Secondary Outcomes (8)

  • VAS of discomfort induced by tinnitus

    it will be assessed after 12 weeks

  • VAS of loudness of tinnitus

    it will be assessed after 12 weeks

  • apnea hyponea index

    it will be assessed after 12 weeks

  • Eporwth sleepiness scale

    it will be assessed after 12 weeks

  • Pittsburgh sleeping quality index

    it will be assessed after 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

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.

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..

Behavioral: diet restriction

Interventions

free walking with dog and diet restrictionBEHAVIORAL

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.

group I
diet restrictionBEHAVIORAL

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..

Group II

Eligibility Criteria

Age30 Years - 45 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Dokki, Giza Governorate, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

TinnitusSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Study Officials

  • Ali Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Isamil, Lecturer

CONTACT

0201005154209ali.mohamed@pt.cu.edu.eg

mona abdelkhalek, Lecturer

CONTACT

020 10 240561083m.sons@gmail.com

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
Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy

Study Record Dates

First Submitted

January 27, 2025

First Posted

January 31, 2025

Study Start

December 12, 2024

Primary Completion

May 15, 2025

Study Completion

May 15, 2025

Last Updated

January 31, 2025

Record last verified: 2025-01

Locations

EG(1)