Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-04-13 @ 8:47 PM
Study NCT ID:
NCT06536894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-05
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fibromyalgia Syndrome on Anthropometric and Ultrasonographic Measurements in Obstructive Sleep Apnea Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anthropometric Measurements', 'timeFrame': 'Day 0 ( Baseline)', 'description': 'Anthropometric measurements will be taken for all patients. These measurements include neck circumference, waist circumference, hip circumference, and with these data, waist-hip ratio and neck-waist circumference ratio will be calculated. Measurements will be made with a tape measure and with patient consent.'}, {'measure': 'Polisomnografi- SLEEP LATENCE', 'timeFrame': 'Day 0 ( Baseline)', 'description': 'Sleep latency time will be measured in polysomnography'}, {'measure': 'Polisomnografi -SLEEP ACTIVITY', 'timeFrame': 'Day 0 ( Baseline)', 'description': 'Sleep efficiency will be measured during polysomnography'}, {'measure': 'Polisomnografi -REM time', 'timeFrame': 'Day 0 ( Baseline)', 'description': 'REM time will be measured in minutes during polysomnography'}, {'measure': 'Polisomnografi -NREM STAGES', 'timeFrame': 'Day 0 ( Baseline)', 'description': 'During polysomnography, NREM stages will be measured at 1 min, 2 min, and 3 min.'}, {'measure': 'Polisomnografi - NUMBERS OF APNE', 'timeFrame': 'Day 0 ( Baseline)', 'description': 'Numbers of apnea will be recorded in polysomnographic measurements.'}, {'measure': 'Polisomnografi -NUMBER OF HYPOPNEA', 'timeFrame': 'Day 0 ( Baseline)', 'description': 'Numbers of hypopnea will be recorded in polysomnographic measurements'}, {'measure': 'Polisomnografi -Apnea hypopnea index (AHI) in polysomnography; Apnea hypopnea index (AHI) will be evaluated on a supine, non-supine basis.', 'timeFrame': 'Day 0 ( Baseline)', 'description': 'Apnea hypopnea index (AHI) will be evaluated in polysomnography.According to the AHI level; It will be classified as SIMPLE SNORING (AHİ\\<5), LIGHT OSAS (AHİ 5-15), MEDIUM OSAS (AHİ 15-30), HEAVY OSAS (AHİ 30+ )'}, {'measure': 'Polisomnografi-REM', 'timeFrame': 'Day 0 ( Baseline)', 'description': 'REM times will be evaluated in polysomnography'}, {'measure': 'Polisomnografi-NonREM', 'timeFrame': 'Day 0 ( Baseline)', 'description': 'NonREM times will be evaluated in polysomnography'}, {'measure': 'Polisomnografi -Apnea hypopnea index (AHI) REM, NONREM in polysomnography; Apnea hypopnea index (AHI) will be evaluated on a supine, non-supine basis.', 'timeFrame': 'Day 0 ( Baseline)', 'description': 'Apnea hypopnea index (AHI) will be evaluated as REM, NONREM, Supine, non-supine in polysomnography.According to the AHI level; It will be classified as SIMPLE SNORING (AHİ\\<5), LIGHT OSAS (AHİ 5-15), MEDIUM OSAS (AHİ 15-30), HEAVY OSAS (AHİ 30+ )'}, {'measure': 'Polisomnografi -OXYGEN DESATURATION INDEX', 'timeFrame': 'Day 0 ( Baseline)', 'description': 'Minimum oxygen saturation and average oxygen saturation will be measured in polysomnography.'}, {'measure': 'submental ultrasonography', 'timeFrame': 'Day 0 ( Baseline)', 'description': 'All patients will undergo submental ultrasonography to measure tongue base thickness and lateral pharyngeal wall thickness.'}], 'secondaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'Day 0 ( Baseline)', 'description': 'The Pittsburgh Sleep Quality Index will be used to evaluate sleep quality. The survey consists of 21 questions and a high score indicates poor sleep quality.'}, {'measure': 'Fibromyalgia Impact Scale', 'timeFrame': 'Day 0 ( Baseline)', 'description': 'The fibromyalgia levels of the participants will be evaluated with the Fibromyalgia Impact Scale. High scores indicate increased disease activity. Consists of 10 questions Maximum score is 80. Turkish validity and reliability was done'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep Disorder', 'Obstructive Sleep Apnea Syndrome', 'Fibromyalgia Syndrome', 'anthropometric measurement', 'ultrasonographic measurement', 'Polysomnography'], 'conditions': ['Fibromyalgia Syndrome', 'Obstructive Sleep Apnea Syndrome']}, 'referencesModule': {'references': [{'pmid': '32601643', 'type': 'BACKGROUND', 'citation': 'Mutlu P, Zateri C, Zohra A, Ozerdogan O, Mirici AN. Prevalence of obstructive sleep apnea in female patients with fibromyalgia. Saudi Med J. 2020 Jul;41(7):740-745. doi: 10.15537/smj.2020.7.25165.'}, {'pmid': '37071285', 'type': 'BACKGROUND', 'citation': 'Cigdem Karacay B, Sahbaz T, Zerman N, Tuncay F. The impact of fibromyalgia syndrome on obstructive sleep apnea syndrome in terms of pain threshold, daytime symptoms, anxiety, depression, disease severity, and sleep quality: a polysomnographic study. Sleep Breath. 2023 Aug;27(4):1473-1479. doi: 10.1007/s11325-023-02831-2. Epub 2023 Apr 18.'}, {'pmid': '35871215', 'type': 'BACKGROUND', 'citation': 'Mohan Lal B, Vyas S, Malhotra A, Ray A, Gupta G, Pandey S, Pandey RM, Aggarwal S, Sinha S. Ultrasonography of the neck in patients with obstructive sleep apnea. Sleep Breath. 2023 Jun;27(3):903-912. doi: 10.1007/s11325-022-02682-3. Epub 2022 Jul 23.'}, {'pmid': '37735660', 'type': 'BACKGROUND', 'citation': 'Deng H, Duan X, Huang J, Zheng M, Lao M, Weng F, Su QY, Zheng ZF, Mei Y, Huang L, Yang WH, Xing X, Ma X, Zhao W, Liu X. Association of adiposity with risk of obstructive sleep apnea: a population-based study. BMC Public Health. 2023 Sep 21;23(1):1835. doi: 10.1186/s12889-023-16695-4.'}]}, 'descriptionModule': {'briefSummary': 'Obstructive type sleep apnea syndrome is a clinical condition characterized by apnea, hypopnea and oxygen desaturation due to narrowing of the upper airway during sleep. Obesity is considered a major predisposing factor for OSAS. In addition, various recent studies have reported that various anthropometric measurements such as neck circumference, waist circumference, hip circumference, waist-hip ratio, neck-waist circumference ratio change (increase) in OSAS patients.', 'detailedDescription': 'Fibromyalgia is a common health problem that is characterized by pain in various parts of the body and is very difficult to diagnose and treat. It affects 2-4% of the population and is more common in women. The presence of OSAS in fibromyalgia patients is more common than in the normal population. There are also common additional symptoms such as excessive daytime sleepiness and delayed sleep latency.\n\nAlthough it has been reported that the presence of OSAS is more common in fibromyalgia patients, there is no study on the presence of anthropometric measurements, especially neck circumference, that are accepted in OSAS.\n\nThe aim of this study is to compare the anthropometric and ultrasonographic measurements of female OSAS patients with and without fibromyalgia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients diagnosed with fibromyalgia who applied to the sleep disorders outpatient clinic operating within the Department of Neurology and underwent polysomnography with sleep problems, as well as patients diagnosed with OSAS, will be included.', 'genderDescription': 'In order to eliminate gender-based factors', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Between 18-65 years old\n* Being diagnosed with fibromyalgia and having applied to the sleep disorders outpatient clinic or being followed up with the diagnosis of OSAS in the sleep disorders outpatient clinic.\n* Agree to participate in the study\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Male patients\n* Not agreeing to participate in the study\n* Neurological diseases that may cause OSAS such as stroke, Parkinson's disease, multiple sclerosis\n* Rheumatological, oncological and hematological diseases\n* Central type obstructive sleep apnea syndrome\n* Thyroid pathology that affects neck circumference measurement"}, 'identificationModule': {'nctId': 'NCT06536894', 'briefTitle': 'Fibromyalgia Syndrome on Anthropometric and Ultrasonographic Measurements in Obstructive Sleep Apnea Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Kirsehir Ahi Evran Universitesi'}, 'officialTitle': 'The Effect of the Presence Fibromyalgia Syndrome on Anthropometric and Ultrasonographic Measurements in Obstructive Sleep Apnea Syndrome', 'orgStudyIdInfo': {'id': 'KAEK_2024-12/95'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fibromyalgia syndrome and obstructive sleep apnea', 'description': 'Fibromyalgia patients who were diagnosed with OSAS as a result of polysomnographic examination'}, {'label': 'Fibromyalgia syndrome', 'description': 'Fibromyalgia patients who were not diagnosed with OSAS as a result of polysomnographic examination'}, {'label': 'Obstructive sleep apnea syndrome.', 'description': 'Patients diagnosed with OSAS as a result of polysomnographic examination and without fibromyalgia'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Basak Cigdem Karacay, Assoc. Prof.', 'role': 'CONTACT', 'email': 'basak.cigdemkaracay@ahievran.edu.tr', 'phone': '+905445094803'}], 'overallOfficials': [{'name': 'Basak Cigdem Karacay, Assoc. Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kirsehir Ahi Evran Universitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirsehir Ahi Evran Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assosc Prof', 'investigatorFullName': 'Basak Cigdem Karacay', 'investigatorAffiliation': 'Kirsehir Ahi Evran Universitesi'}}}}