Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2026-01-14 @ 3:09 AM
Study NCT ID:
NCT06803095
Status:
RECRUITING
Last Update Posted:
2025-01-31
First Post:
2025-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Walking Exercise With Dog on Tinnitus Complaints in Sleep Apnea (Obstructive Sleep Apnea)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tinnitus handicap inventory', 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it is a questionaire assess tinnitus-associating life quality'}], 'secondaryOutcomes': [{'measure': 'VAS of discomfort induced by tinnitus', 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it is 10 com visual analogue scale'}, {'measure': 'VAS of loudness of tinnitus', 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it is 10 com visual analogue scale'}, {'measure': 'apnea hyponea index', 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it is number of occurrences of apnea and hyponea in hour'}, {'measure': 'Eporwth sleepiness scale', 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it will assess daytime sleepiness'}, {'measure': 'Pittsburgh sleeping quality index', 'timeFrame': 'it will be assessed after 12 weeks', 'description': 'it will assess sleep quality (subjective assessment)'}, {'measure': 'Questionnaire of Depression, Anxiety, Stress Scales', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'it will contain 42 questions assessing psychological status (Depression, Anxiety, Stress) of participants'}, {'measure': 'body mass index', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'it will be measured on empty stomach'}, {'measure': 'wait circumference', 'timeFrame': 'it will be measured after 12 weeks', 'description': 'it will be measured at umbilical level'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tinnitus, Subjective', 'Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'self-representation of gender identity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obese persons\n* bilateral chronic subjective tinnitus\n* mild obstructive sleep apnea (mild apnea hypopnea index)\n* forty participants\n\nExclusion Criteria:\n\n* body mass index more than 40 kg/m2.\n* cardiovascular problems\n* hepatorenal probelms\n* autoimmune problems\n* orthopedic probelms'}, 'identificationModule': {'nctId': 'NCT06803095', 'briefTitle': 'Efficacy of Walking Exercise With Dog on Tinnitus Complaints in Sleep Apnea (Obstructive Sleep Apnea)', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy of Walking Exercise With Dog on Tinnitus Complaints in Sleep Apnea', 'orgStudyIdInfo': {'id': 'IRB00014233-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group I', 'description': '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.', 'interventionNames': ['Behavioral: free walking with dog and diet restriction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', 'description': '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..', 'interventionNames': ['Behavioral: diet restriction']}], 'interventions': [{'name': 'free walking with dog and diet restriction', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['group I']}, {'name': 'diet restriction', 'type': 'BEHAVIORAL', 'description': '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..', 'armGroupLabels': ['Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11432', 'city': 'Dokki', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ali AM Ismail, lecturer', 'role': 'CONTACT', 'email': 'ali.mohamed@pt.cu.edu.eg', 'phone': '+201005154209'}, {'name': 'mona abdelkhalek, PHD', 'role': 'CONTACT', 'email': '3m.sons@gmail.com', 'phone': '+20 10 24056108'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.03823, 'lon': 31.2113}}], 'centralContacts': [{'name': 'Ali Isamil, Lecturer', 'role': 'CONTACT', 'email': 'ali.mohamed@pt.cu.edu.eg', 'phone': '0201005154209'}, {'name': 'mona abdelkhalek, Lecturer', 'role': 'CONTACT', 'email': '3m.sons@gmail.com', 'phone': '020 10 24056108'}], 'overallOfficials': [{'name': 'Ali Ismail, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy', 'investigatorFullName': 'Ali Mohamed Ali ismail', 'investigatorAffiliation': 'Cairo University'}}}}