Is Asthma in Subjects With Obstructive Sleep Apnoea (OSA) Due to Dysanapsis
NCT ID: NCT04142905
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
200 participants
OBSERVATIONAL
2021-02-10
2025-10-01
Brief Summary
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Detailed Description
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Obesity 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.
High 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.
AIM: 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
NULL 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.
Methods
Initially 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.
The 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.
References - Refer to References Section
Appendix 1
Data Collection Sheet for those with confirmed diagnosis of Obstructive sleep apnoea
Name and Date of Birth and details
Age
Weight \_\_\_\_\_\_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)
DATE of Test \_\_\_/\_\_\_/\_\_\_FEV1\_\_\_\_\_\_\_FEV1%\_\_\_\_\_\_\_
FVC\_\_\_\_\_\_\_\_\_FVC%\_\_\_\_\_\_\_\_\_\_
DATE of Test \_\_\_/\_\_\_/\_\_\_FEV1\_\_\_\_\_\_\_FEV1%\_\_\_\_\_\_\_
FVC\_\_\_\_\_\_\_\_\_FVC%\_\_\_\_\_\_\_\_\_\_
Dysanapsis FEV1/FVC \<0.8 Yes/No FEV1/FVC \<0.7 Yes/No (circle correct)
AHI/hr 5-15 16-29 \>30 (circle correct)
Eosinophil count MAX in past 12 months\_\_\_\_\_\_\_\_x109/L MAX ever \_\_\_\_\_\_ x109/L
DATE\_\_\_\_\_\_\_\_
RAST test positive for which antigens
Smoking history start age\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Pack years\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Patients With Asthma
Subjects with sleep disordered breathing with asthma
No interventions assigned to this group
Patients Without Asthma
Subjects with sleep disordered breathing without asthma
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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Julie Dawson
OTHER
Responsible Party
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Julie Dawson
Research Services Manager
Locations
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Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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269072
Identifier Type: -
Identifier Source: org_study_id