Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT04835558
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2021-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010845', 'term': 'Obesity Hypoventilation Syndrome'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007040', 'term': 'Hypoventilation'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-04', 'studyFirstSubmitDate': '2021-03-28', 'studyFirstSubmitQcDate': '2021-04-04', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incremental load test', 'timeFrame': '1 day', 'description': 'Respiratory muscle endurance was evaluated by incremental load test. The incremental load test was performed using the electronic inspiratory loading device (PowerBreathe®-KHP2).'}], 'secondaryOutcomes': [{'measure': 'Mouth pressure measurements', 'timeFrame': '1 day', 'description': 'Respiratory muscle strength was measured using mouth pressure measurements (Micro Medical MicroRPM).'}, {'measure': '6 minute walk test', 'timeFrame': '1 day', 'description': 'The 6 minute walk test was used to evaluate the functional exercise capacity of the subjects.'}, {'measure': 'Epworth Sleepiness Scale', 'timeFrame': '1 day', 'description': 'Excessive daytime sleepiness was assessed with the Epworth Sleepiness Scale. A score of \\>10 accepted as daytime sleepiness.'}, {'measure': 'Pittsburg Sleep Quality Index', 'timeFrame': '1 day', 'description': 'Sleep quality was assessed with the Pittsburg Sleep Quality Index. The total score were interpreted as follows: 0-5 indicated good sleep quality, \\> 5 indicated poor sleep quality, and \\>10 indicated the presence of a sleep disorder.'}, {'measure': 'Fatigue Severity Scale', 'timeFrame': '1 day', 'description': 'Fatigue severity was assessed with the Fatigue Severity Scale. This seven-likert scale was used for each item and final score was accepted as mean value of the 9 items. The higher scores indicated higher fatigue severity.'}, {'measure': 'EQ-5D Health-Related Quality of Life Questionnaire', 'timeFrame': '1 day', 'description': 'Quality of life was assessed with the EQ-5D Health-Related Quality of Life Questionnaire. The maximum score of 1 indicates the best health state, and higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status in which 100 indicates the best health status.'}, {'measure': 'Obesity and Weight Loss Quality of Life Instrument', 'timeFrame': '1 day', 'description': 'Quality of life specific to obesity was assessed with the Obesity and Weight Loss Quality of Life Instrument. As the total score from the scale approaches 0, the quality of life decreases, and as it approaches 100, the quality of life increases.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory Muscle Endurance', 'Sleep', 'Fatigue', 'Quality of Life'], 'conditions': ['Obesity Hypoventilation Syndrome (OHS)']}, 'descriptionModule': {'briefSummary': 'Obesity hypoventilation syndrome (OHS) is defined as a combination of obesity \\[body mass index (BMI) ≥30 kg/m2\\], chronic daytime hypercapnia (PaCO2 \\>45 mm Hg), and sleep-apnea in the absence of other known causes of hypercapnia. Respiratory system compliance decreases and resistance increases in OHS. This causes increase in work of breathing and oxygen cost of breathing, which may result in respiratory muscle fatigue. Increase in respiratory workload and increase in resistance to respiration is expected to decrease in respiratory muscle endurance (RME) in subjects with OHS.', 'detailedDescription': 'In the literature, studies evaluating RME in subjects with OHS are limited. No study has been found to evaluate RME using the incremental load test in subjects with OHS. Accordingly, it was aimed to evaluate and compare respiratory muscle endurance in subjects with OHS and a control group, and to determine factors associated with respiratory muscle endurance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '24 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects who had polysomnography performed in the sleep laboratory and were diagnosed with OHS were screened.\n\nAge and sex-matched obese subjects (30 \\< body mass index \\< 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score \\< 3) included in the study as the control group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with OHS\n* Obese subjects (30 \\< body mass index \\< 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score \\< 3)\n\nExclusion Criteria:\n\n* Severe respiratory disease\n* Subjects with orthopeadic and/or neurologic disorders that could limit exercise tests'}, 'identificationModule': {'nctId': 'NCT04835558', 'briefTitle': 'Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome; Evaluation by Incremental Load Test', 'orgStudyIdInfo': {'id': '29713'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'description': 'Subjects with obesity hypoventilation sydrome (30 \\< body mass index \\< 40 kg/m2)'}, {'label': 'Group II', 'description': 'Subjects with obesity hypoventilation sydrome (body mass index \\> 40 kg/m2)'}, {'label': 'Control Group', 'description': 'Age and sex-matched obese subjects (30 \\< body mass index \\< 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score \\< 3)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Goksen Kuran Aslan', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}