Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT04621032
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2020-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Obstructive Sleep Apnea Destabilizes Myocardial Repolarization Homogeneity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}], 'ancestors': [{'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'}, {'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': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015716', 'term': 'Electrocardiography, Ambulatory'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}], 'ancestors': [{'id': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D018670', 'term': 'Monitoring, Ambulatory'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-24', 'studyFirstSubmitDate': '2020-11-03', 'studyFirstSubmitQcDate': '2020-11-06', 'lastUpdatePostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A number of patients with visceral obesity and Obstructive Sleep Apnea', 'timeFrame': 'one day per each patient', 'description': 'Polygraphy examination of each patient'}], 'secondaryOutcomes': [{'measure': 'A number of patients with visceral obesity and heart rhythm disorders occurrence.', 'timeFrame': 'Holter ECG - one day per patient', 'description': 'Holter-ECG monitoring of each patient'}, {'measure': 'Correlation of Obstructive Sleep Apnea and ECG changes among OSA positive and negative patients', 'timeFrame': '2016-2019', 'description': 'statistical analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea', 'QT interval', 'QTV', 'QTc', 'repolarisation homogeneity'], 'conditions': ['Obstructive Sleep Apnea', 'Heart Rhythm Disorder', 'Obesity, Abdominal']}, 'referencesModule': {'references': [{'pmid': '19720569', 'type': 'BACKGROUND', 'citation': 'Alam I, Lewis MJ, Lewis KE, Stephens JW, Baxter JN. Influence of bariatric surgery on indices of cardiac autonomic control. Auton Neurosci. 2009 Dec 3;151(2):168-73. doi: 10.1016/j.autneu.2009.08.007. Epub 2009 Aug 31.'}, {'type': 'BACKGROUND', 'citation': '2. American Academy of Sleep Medicine. International classification of sleep disorders, 2nd ed. Diagnostic and coding manual. Westchester, Illinois: American Academy of Sleep Medicine 2005. Updated November 2015. Darien, IL: American Academy of Sleep medicine, 2016.'}, {'pmid': '10450601', 'type': 'BACKGROUND', 'citation': 'Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep. 1999 Aug 1;22(5):667-89. No abstract available.'}, {'pmid': '20567204', 'type': 'BACKGROUND', 'citation': 'Arslan E, Yiginer O, Yavasoglu I, Ozcelik F, Kardesoglu E, Nalbant S. Effect of uncomplicated obesity on QT interval in young men. Pol Arch Med Wewn. 2010 Jun;120(6):209-13.'}, {'pmid': '20552591', 'type': 'BACKGROUND', 'citation': 'Barta K, Szabo Z, Kun C, Munkacsy C, Bene O, Magyar MT, Csiba L, Lorincz I. The effect of sleep apnea on QT interval, QT dispersion, and arrhythmias. Clin Cardiol. 2010 Jun;33(6):E35-9. doi: 10.1002/clc.20619.'}, {'pmid': '21257917', 'type': 'BACKGROUND', 'citation': 'Baumert M, Schlaich MP, Nalivaiko E, Lambert E, Sari CI, Kaye DM, Elser MD, Sanders P, Lambert G. Relation between QT interval variability and cardiac sympathetic activity in hypertension. Am J Physiol Heart Circ Physiol. 2011 Apr;300(4):H1412-7. doi: 10.1152/ajpheart.01184.2010. Epub 2011 Jan 21.'}, {'pmid': '26823389', 'type': 'BACKGROUND', 'citation': 'Baumert M, Porta A, Vos MA, Malik M, Couderc JP, Laguna P, Piccirillo G, Smith GL, Tereshchenko LG, Volders PG. QT interval variability in body surface ECG: measurement, physiological basis, and clinical value: position statement and consensus guidance endorsed by the European Heart Rhythm Association jointly with the ESC Working Group on Cardiac Cellular Electrophysiology. Europace. 2016 Jun;18(6):925-44. doi: 10.1093/europace/euv405. Epub 2016 Jan 27.'}, {'pmid': '18652091', 'type': 'BACKGROUND', 'citation': 'Baumert M, Smith J, Catcheside P, McEvoy RD, Abbott D, Sanders P, Nalivaiko E. Variability of QT interval duration in obstructive sleep apnea: an indicator of disease severity. Sleep. 2008 Jul;31(7):959-66.'}, {'pmid': '15788497', 'type': 'BACKGROUND', 'citation': 'Gami AS, Howard DE, Olson EJ, Somers VK. Day-night pattern of sudden death in obstructive sleep apnea. N Engl J Med. 2005 Mar 24;352(12):1206-14. doi: 10.1056/NEJMoa041832.'}, {'pmid': '23770166', 'type': 'BACKGROUND', 'citation': 'Gami AS, Olson EJ, Shen WK, Wright RS, Ballman KV, Hodge DO, Herges RM, Howard DE, Somers VK. Obstructive sleep apnea and the risk of sudden cardiac death: a longitudinal study of 10,701 adults. J Am Coll Cardiol. 2013 Aug 13;62(7):610-6. doi: 10.1016/j.jacc.2013.04.080. Epub 2013 Jun 13.'}, {'pmid': '15464332', 'type': 'BACKGROUND', 'citation': 'Haigney MC, Zareba W, Gentlesk PJ, Goldstein RE, Illovsky M, McNitt S, Andrews ML, Moss AJ; Multicenter Automatic Defibrillator Implantation Trial II investigators. QT interval variability and spontaneous ventricular tachycardia or fibrillation in the Multicenter Automatic Defibrillator Implantation Trial (MADIT) II patients. J Am Coll Cardiol. 2004 Oct 6;44(7):1481-7. doi: 10.1016/j.jacc.2004.06.063.'}, {'pmid': '19406266', 'type': 'BACKGROUND', 'citation': 'Hinterseer M, Beckmann BM, Thomsen MB, Pfeufer A, Dalla Pozza R, Loeff M, Netz H, Steinbeck G, Vos MA, Kaab S. Relation of increased short-term variability of QT interval to congenital long-QT syndrome. Am J Cardiol. 2009 May 1;103(9):1244-8. doi: 10.1016/j.amjcard.2009.01.011. Epub 2009 Mar 18.'}, {'type': 'BACKGROUND', 'citation': '14. Report of a WHO Expert Consultation. Waist circumference and waist-hip ratio. Geneva, 8-11 Dec 2008.'}, {'pmid': '19237685', 'type': 'BACKGROUND', 'citation': 'Mathieu P, Poirier P, Pibarot P, Lemieux I, Despres JP. Visceral obesity: the link among inflammation, hypertension, and cardiovascular disease. Hypertension. 2009 Apr;53(4):577-84. doi: 10.1161/HYPERTENSIONAHA.108.110320. Epub 2009 Feb 23. No abstract available.'}, {'pmid': '16424443', 'type': 'BACKGROUND', 'citation': 'Mehra R, Benjamin EJ, Shahar E, Gottlieb DJ, Nawabit R, Kirchner HL, Sahadevan J, Redline S; Sleep Heart Health Study. Association of nocturnal arrhythmias with sleep-disordered breathing: The Sleep Heart Health Study. Am J Respir Crit Care Med. 2006 Apr 15;173(8):910-6. doi: 10.1164/rccm.200509-1442OC. Epub 2006 Jan 19.'}, {'pmid': '24223313', 'type': 'BACKGROUND', 'citation': 'Menon A, Kumar M. Influence of body position on severity of obstructive sleep apnea: a systematic review. ISRN Otolaryngol. 2013 Oct 8;2013:670381. doi: 10.1155/2013/670381.'}, {'pmid': '11786943', 'type': 'BACKGROUND', 'citation': 'Murabayashi T, Fetics B, Kass D, Nevo E, Gramatikov B, Berger RD. Beat-to-beat QT interval variability associated with acute myocardial ischemia. J Electrocardiol. 2002 Jan;35(1):19-25. doi: 10.1054/jelc.2002.30250.'}, {'pmid': '18640686', 'type': 'BACKGROUND', 'citation': 'Myredal A, Karlsson AK, Johansson M. Elevated temporal lability of myocardial repolarization after coronary artery bypass grafting. J Electrocardiol. 2008 Nov-Dec;41(6):698-702. doi: 10.1016/j.jelectrocard.2008.06.004. Epub 2008 Jul 21.'}, {'pmid': '16093922', 'type': 'BACKGROUND', 'citation': 'Myredal A, Gao S, Friberg P, Jensen G, Larsson L, Johansson M. Increased myocardial repolarization lability and reduced cardiac baroreflex sensitivity in individuals with high-normal blood pressure. J Hypertens. 2005 Sep;23(9):1751-6. doi: 10.1097/01.hjh.0000179762.93291.94.'}, {'pmid': '14738673', 'type': 'BACKGROUND', 'citation': 'Papaioannou A, Michaloudis D, Fraidakis O, Petrou A, Chaniotaki F, Kanoupakis E, Stamatiou G, Melissas J, Askitopoulou H. Effects of weight loss on QT interval in morbidly obese patients. Obes Surg. 2003 Dec;13(6):869-73. doi: 10.1381/096089203322618687.'}, {'pmid': '20202954', 'type': 'BACKGROUND', 'citation': 'Romero-Corral A, Caples SM, Lopez-Jimenez F, Somers VK. Interactions between obesity and obstructive sleep apnea: implications for treatment. Chest. 2010 Mar;137(3):711-9. doi: 10.1378/chest.09-0360.'}, {'pmid': '12453544', 'type': 'BACKGROUND', 'citation': 'Sosnowski M, Czyz Z, Tendera M. Time and frequency analysis of beat-to-beat R-T interval variability in patients with ischaemic left ventricular dysfunction providing evidence for non-neural control of ventricular repolarisation. Eur J Heart Fail. 2002 Dec;4(6):737-43. doi: 10.1016/s1388-9842(02)00167-8.'}, {'type': 'BACKGROUND', 'citation': 'Strack C, Fessman D, Fenk S, Waldmann K, Kempinger S, Loew T, et al. QT prolongation is frequently observed in obesity with and without the metabolic syndrome and can be reversed by long term weight reduction. Eur Heart J 2013 34:4287.'}, {'pmid': '28899529', 'type': 'BACKGROUND', 'citation': 'Viigimae M, Karai D, Pilt K, Pirn P, Huhtala H, Polo O, Meigas K, Kaik J. QT interval variability index and QT interval duration during different sleep stages in patients with obstructive sleep apnea. Sleep Med. 2017 Sep;37:160-167. doi: 10.1016/j.sleep.2017.06.026. Epub 2017 Jul 22.'}, {'pmid': '10819405', 'type': 'BACKGROUND', 'citation': 'Vrtovec B, Starc V, Starc R. Beat-to-beat QT interval variability in coronary patients. J Electrocardiol. 2000 Apr;33(2):119-25. doi: 10.1016/s0022-0736(00)80068-0.'}, {'type': 'BACKGROUND', 'citation': '28. Woosley R.L., Romero K.A., www.Crediblemeds.org, QTdrugs List, [access date 05 May 2019, AZCERT, Inc. 1822 Innovation Park Dr., Oro Valley, AZ 85755.'}]}, 'descriptionModule': {'briefSummary': 'Literature shows that patients with obesity and Obstructive Sleep Apnea (OSA), both occurring independently, are more likely to develop cardiovascular diseases and sudden cardiac death (SCD). Assuming that ventricular depolarization is more stable than repolarization then QT interval parameters may be used for heart muscle repolarization assessment for those groups of patients.\n\nThere were 121 patients included in the study, both - women and men, aging from 35-65 with visceral obesity. Only healthy patients were included - the ones who were not treated for any chronic disease, taking QT elongating drugs, or were not treated with Continuous Positive Airway Pressure (CPAP) therapy at that time.', 'detailedDescription': "The current study was a prospective, observational clinical trial performed between September 2016 and August 2019 at a single-center institution specializing in treatment of patients with obstructive sleep apnea. The inclusion criteria were as follows: (1) gender: female or male, (2) age 35-65 years old, (3) visceral obesity, (4) lack of acute or chronic diseases that may have an influence on rhythm or conduction disorders, (5) not undergoing Continuous Positive Airway Pressure therapy (CPAP) or taking drugs that have or may have an influence on QT interval duration \\[according to Credible Meds list (Woosley et al, 2019)\\], (6) not consuming grapefruits or grapefruit juice for at least 2 weeks before Holter-ECG examination. Patients, who met all inclusion criteria, underwent subject and physical examination, an over-night Holter-ECG, polygraphy and laboratory biochemical tests (sodium, potassium, calcium, magnesium concentration and fasting glyceamia.\n\nEnrolled patients were asked questions about general frame of mind, daytime and nighttime symptoms that may suggest OSA \\[according to Epworth Sleepiness Scale (https://epworthsleepinessscale.com/about-the-ess/ access date 08 May 2020)\\]. All patients were fully physically examined. Neck and waist circumference were measured according to STEPwise Approach to Surveillance (STEPS) by WHO (https://www.who.int/ncds/surveillance/steps/en/. \\[access date 23 April.2019\\]. Upon subject examination (snoring and choking feeling during the sleep) a corrected neck circumference was calculated.\n\nPolygraphy was conducted using MED Recorder device by Infoscan company according to AASM guidelines (American Academy of Sleep Medicine, International classification of sleep disorders, 2016). The device registered blood saturation, heart rate, airflow, chest and abdomen movements, body position, snoring and single lead ECG. OSA was diagnosed according to AASM definition (American Academy of Sleep Medicine, Sleep-related breathing disorders in adults, 1999): in every patient with Respiratory Disturbance Index (RDI) ≥ 5/hour and with concomitant OSA sings (Epworth Sleepiness Scale ≥ 11 pts) or with RDI ≥ 15/hour. The minimum time of analyzed data without artifacts had to last at least 6 h.\n\nA Holter-ECG examination was conducted using DMS 300-3A device by Oxford company suitable for Cardioscan 10 system. Registration was made simultaneously with polygraphy, during the night. Chosen QT interval assessment parameters were evaluated upon partially automatically analyzed fragments of ECG records. Only nighttime ECG records were analyzed due to maximum comparability (similar patient's physical activity and minimized, because of limited body movements, artifacts). Moreover, the study aimed to assess a heart's activity simultaneous to sleep breathing disorders. Only ECG strips with constant heart rate, optimally within 50-70/min limits, were chosen due to the minimum impact of such heart rate on QT interval correction formula. QTc data was calculated upon Bazett's formula. QTV and QTVi were calculated upon Berger's formula.\n\nAfter getting all results they were checked against the following exclusion criteria: 1) revealing that information about patient's chronic illness or drugs therapy was obfuscated, revealing increased fasting serum glucose concentration or ionic disturbances. It was strongly recommended to every patient to visit their GP for further diagnostics, 2) revealing any important deviation in physical examination i.a. blood pressure taken twice at the visit ≥140/ ≥90 mmHg, 3) revealing, upon Holter ECG examination, tachycardia or too numerous artifacts making QT interval assessment incredible, 4) too short total sleep time (\\< 6 hours) registered on polygraphy.\n\nOut of 187 consecutive patients meeting the inclusion criteria, 66 patients met at least one exclusion criterion, leaving 121 patients for the study analyses."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Out of 187 consecutive patients meeting the inclusion criteria, 66 patients met at least one exclusion criterion, leaving 121 patients for the study analyses.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* gender: female or male,\n* age 35-65 years old,\n* visceral obesity,\n* lack of acute or chronic diseases that may have an influence on rhythm or conduction disorders,\n* not undergoing Continuous Positive Airway Pressure therapy (CPAP) or taking drugs that have or may have an influence on QT interval duration \\[according to Credible Meds list (Woosley et al, 2019)\\],\n* not consuming grapefruits or grapefruit juice for at least 2 weeks before Holter-ECG examination.\n\nExclusion Criteria:\n\n* revealing that information about patient's chronic illness or drugs therapy was obfuscated, revealing increased fasting serum glucose concentration or ionic disturbances. It was strongly recommended to every patient to visit their GP for further diagnostics,\n* revealing any important deviation in physical examination i.a. blood pressure taken twice at the visit ≥140/ ≥90 mmHg,\n* revealing, upon Holter ECG examination, tachycardia or too numerous artifacts making QT interval assessment incredible,\n* too short total sleep time (\\< 6 hours) registered on polygraphy."}, 'identificationModule': {'nctId': 'NCT04621032', 'briefTitle': 'Obstructive Sleep Apnea Destabilizes Myocardial Repolarization Homogeneity', 'organization': {'class': 'OTHER', 'fullName': 'Nowodworskie Centrum Medyczne'}, 'officialTitle': 'Obstructive Sleep Apnea Destabilizes Myocardial Repolarization Homogeneity', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OSA +', 'description': 'Patients with visceral obesity and newly diagnosed Obstructive Sleep Apnea (during the study)', 'interventionNames': ['Diagnostic Test: Polygraphy monitoring', 'Diagnostic Test: laboratory tests']}, {'label': 'OSA -', 'description': 'Patients with visceral obesity in whom Obstructive Sleep Apnea diagnosis have been excluded (during the study)', 'interventionNames': ['Diagnostic Test: Polygraphy monitoring', 'Diagnostic Test: laboratory tests']}], 'interventions': [{'name': 'Polygraphy monitoring', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Holter ECG monitoring'], 'description': 'All patients with visceral obesity have been tested for Obstructive Sleep Apnea and heart rhythm disorders by usage of polygraphy and Holter-ECG monitoring.', 'armGroupLabels': ['OSA +', 'OSA -']}, {'name': 'laboratory tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood samples for sodium, potassium, calcium, magnesium concentration and fasting glyceamia assessment hae been taken from all patients with visceral obesity.', 'armGroupLabels': ['OSA +', 'OSA -']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Aleksandra Jarecka-Dobroń, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NowodworskieMD'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'As soon as posible after getting the request.', 'ipdSharing': 'YES', 'description': 'For a reasonable request the principal intevstigator will share stastical data of studied group.', 'accessCriteria': 'All requests will be considered by the main investigator and data will be send to the indicated e-mail.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nowodworskie Centrum Medyczne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of Warsaw', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical doctor, PhD', 'investigatorFullName': 'Aleksandra Jarecka-Dobroń', 'investigatorAffiliation': 'Nowodworskie Centrum Medyczne'}}}}