Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-01-01 @ 1:09 AM
Study NCT ID:
NCT04142905
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-22
First Post:
2019-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Asthma in Subjects With Obstructive Sleep Apnoea (OSA) Due to Dysanapsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2019-10-25', 'studyFirstSubmitQcDate': '2019-10-25', 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Defined dysynapsis in patients with asthma and obstructive sleep apnoea (OSA)', 'timeFrame': '6 years', 'description': 'The investigator will refer to the Sleep Disordered Breathing Clinic records to investigate the prevalence of dysanapsis in patients with Sleep disordered breathing, in patients with asthma compared to those without asthma.'}], 'secondaryOutcomes': [{'measure': 'Apnea-Hypopnea Index (AHI)', 'timeFrame': '6 years', 'description': 'The investigator will refer to the Sleep Disordered Breathing Clinic records to compare measures of Apnea-Hypopnea Index (AHI) in patients with and without asthma.'}, {'measure': 'Eosinophil count', 'timeFrame': '6 years', 'description': 'The investigator will refer to the Sleep Disordered Breathing Clinic records to compare Eosinophil count in patients with and without asthma.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma', 'Obstructive Sleep Apnoea (OSA)', 'Dysanapis']}, 'referencesModule': {'references': [{'pmid': '19912154', 'type': 'BACKGROUND', 'citation': 'Anandan C, Nurmatov U, van Schayck OC, Sheikh A. Is the prevalence of asthma declining? Systematic review of epidemiological studies. Allergy. 2010 Feb;65(2):152-67. doi: 10.1111/j.1398-9995.2009.02244.x. Epub 2009 Nov 12.'}, {'pmid': '25371419', 'type': 'BACKGROUND', 'citation': 'Mukherjee M, Gupta R, Farr A, Heaven M, Stoddart A, Nwaru BI, Fitzsimmons D, Chamberlain G, Bandyopadhyay A, Fischbacher C, Dibben C, Shields M, Phillips C, Strachan D, Davies G, McKinstry B, Sheikh A; Burden and True Cost of Asthma in the UK Research Team. Estimating the incidence, prevalence and true cost of asthma in the UK: secondary analysis of national stand-alone and linked databases in England, Northern Ireland, Scotland and Wales-a study protocol. BMJ Open. 2014 Nov 4;4(11):e006647. doi: 10.1136/bmjopen-2014-006647.'}, {'pmid': '16963682', 'type': 'BACKGROUND', 'citation': 'Jones RL, Nzekwu MM. The effects of body mass index on lung volumes. Chest. 2006 Sep;130(3):827-33. doi: 10.1378/chest.130.3.827.'}, {'pmid': '16627866', 'type': 'BACKGROUND', 'citation': 'Beuther DA, Weiss ST, Sutherland ER. Obesity and asthma. Am J Respir Crit Care Med. 2006 Jul 15;174(2):112-9. doi: 10.1164/rccm.200602-231PP. Epub 2006 Apr 20.'}, {'pmid': '11641506', 'type': 'BACKGROUND', 'citation': 'von Mutius E, Schwartz J, Neas LM, Dockery D, Weiss ST. Relation of body mass index to asthma and atopy in children: the National Health and Nutrition Examination Study III. Thorax. 2001 Nov;56(11):835-8. doi: 10.1136/thorax.56.11.835.'}, {'pmid': '26504195', 'type': 'BACKGROUND', 'citation': 'Colak Y, Afzal S, Lange P, Nordestgaard BG. Obese individuals experience wheezing without asthma but not asthma without wheezing: a Mendelian randomisation study of 85,437 adults from the Copenhagen General Population Study. Thorax. 2016 Mar;71(3):247-54. doi: 10.1136/thoraxjnl-2015-207379. Epub 2015 Oct 26.'}, {'pmid': '15591475', 'type': 'BACKGROUND', 'citation': 'Sulit LG, Storfer-Isser A, Rosen CL, Kirchner HL, Redline S. Associations of obesity, sleep-disordered breathing, and wheezing in children. Am J Respir Crit Care Med. 2005 Mar 15;171(6):659-64. doi: 10.1164/rccm.200403-398OC. Epub 2004 Dec 10.'}, {'pmid': '27552676', 'type': 'BACKGROUND', 'citation': 'Forno E, Weiner DJ, Mullen J, Sawicki G, Kurland G, Han YY, Cloutier MM, Canino G, Weiss ST, Litonjua AA, Celedon JC. Obesity and Airway Dysanapsis in Children with and without Asthma. Am J Respir Crit Care Med. 2017 Feb 1;195(3):314-323. doi: 10.1164/rccm.201605-1039OC.'}]}, 'descriptionModule': {'briefSummary': 'Intention to review patient letters from sleep clinic to see if their lung function fit in with Dysynapsis in wheezing patients or if it is true asthma', 'detailedDescription': "There is no evidence that the World Wide prevalence of asthma is declining. There is some evidence that this Western disease may give the appearance of declining prevalence due to improved healthcare. However evidence from the Office of National Statistics suggests that the mortality rate for asthma may be increasing year on since 2007 until 2017. The true burden of asthma in the United Kingdom is difficult to ascertain.\n\nObesity has effects on lung function which lead to low functional residual capacity and low end reserve volume. This leads to rapid shallow breaths near to the airway closing pressure and lung closing volume as illustrated in this review. This suggests that obesity itself may be a source of breathlessness.\n\nHigh Body Mass Index (BMI) has been shown to be associated with asthma. It was also associated with wheeze that is not asthma. This finding suggests that obesity in itself may be linked to wheeze which is not asthma. It has been shown in children that sleep disordered breathing is associated with asthma as well as wheeze. Obese children are known to display dysanapsis (airway cross sectional area is small for the size of the lung) whether associated with or without asthma, however if associated with asthma, the severity of asthma can be worse.\n\nAIM: To investigate if asthma is truly associated with Sleep disordered breathing in adult subjects. To investigate if there is an association of wheeze with dysanapsis in patients with sleep disordered breathing\n\nNULL HYPOTHESIS: There is no difference between subjects who have sleep disordered breathing with asthma and those subjects who have sleep disordered breathing without asthma, with respect to lung function parameters.\n\nMethods\n\nInitially the investigators' aim is to interrogate clinical records and look at lung function testing in subjects with and without asthma who attend the sleep disordered breathing clinic. The investigators intend to investigate 100 with asthma in the sleep clinic and 100 without asthma in the sleep clinic. The Investigators will also look at eosinophil results of those with asthma compared to those without asthma and any markers of atopy.\n\nThe investigators will use Statistical Package for the Social Sciences (SPSS) to undertake simple frequency analysis and cross tabs as well as odds ratio from binary logistic regression.\n\nReferences - Refer to References Section\n\nAppendix 1\n\nData Collection Sheet for those with confirmed diagnosis of Obstructive sleep apnoea\n\nName and Date of Birth and details\n\nAge\n\nWeight \\_\\_\\_\\_\\_\\_Height\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_Body Mass Index \\_\\_\\_\\_\\_\\_\\_\\_\\_Gender at birth \\_\\_\\_Male\\_\\_\\_\\_Female\\_\\_\\_ Asthma diagnosis made by General Practitioner or Respiratory physician or no diagnosis of asthma (circle correct)\n\nDATE of Test \\_\\_\\_/\\_\\_\\_/\\_\\_\\_FEV1\\_\\_\\_\\_\\_\\_\\_FEV1%\\_\\_\\_\\_\\_\\_\\_\n\nFVC\\_\\_\\_\\_\\_\\_\\_\\_\\_FVC%\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nDATE of Test \\_\\_\\_/\\_\\_\\_/\\_\\_\\_FEV1\\_\\_\\_\\_\\_\\_\\_FEV1%\\_\\_\\_\\_\\_\\_\\_\n\nFVC\\_\\_\\_\\_\\_\\_\\_\\_\\_FVC%\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nDysanapsis FEV1/FVC \\<0.8 Yes/No FEV1/FVC \\<0.7 Yes/No (circle correct)\n\nAHI/hr 5-15 16-29 \\>30 (circle correct)\n\nEosinophil count MAX in past 12 months\\_\\_\\_\\_\\_\\_\\_\\_x109/L MAX ever \\_\\_\\_\\_\\_\\_ x109/L\n\nDATE\\_\\_\\_\\_\\_\\_\\_\\_\n\nRAST test positive for which antigens\n\nSmoking history start age\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_ Pack years\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients attending the Obstructive Sleep Apnea Clinic at Norfolk \\& Norwich University Hospital NHS Foundation Trust', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any subject in Obstructive Sleep Apnea clinic.\n\nExclusion Criteria:\n\n* Only exclusion criteria is if they have no recorded lung function in their notes'}, 'identificationModule': {'nctId': 'NCT04142905', 'briefTitle': 'Is Asthma in Subjects With Obstructive Sleep Apnoea (OSA) Due to Dysanapsis', 'organization': {'class': 'OTHER', 'fullName': 'Norfolk and Norwich University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Is Asthma in Subjects With Obstructive Sleep Apnoea (OSA) Due to Dysanapsis', 'orgStudyIdInfo': {'id': '269072'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients With Asthma', 'description': 'Subjects with sleep disordered breathing with asthma'}, {'label': 'Patients Without Asthma', 'description': 'Subjects with sleep disordered breathing without asthma'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NR4 7UY', 'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Julie Dawson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Services Manager', 'investigatorFullName': 'Julie Dawson', 'investigatorAffiliation': 'Norfolk and Norwich University Hospitals NHS Foundation Trust'}}}}