Is Asthma in Subjects With Obstructive Sleep Apnoea (OSA) Due to Dysanapsis

December 18, 2023 updated by: Julie Dawson
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

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

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.

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________________

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospitals Nhs Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients attending the Obstructive Sleep Apnea Clinic at Norfolk & Norwich University Hospital NHS Foundation Trust

Description

Inclusion Criteria:

  • Any subject in Obstructive Sleep Apnea clinic.

Exclusion Criteria:

  • Only exclusion criteria is if they have no recorded lung function in their notes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Patients With Asthma
Subjects with sleep disordered breathing with asthma
Patients Without Asthma
Subjects with sleep disordered breathing without asthma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Defined dysynapsis in patients with asthma and obstructive sleep apnoea (OSA)
Time Frame: 6 years
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.
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-Hypopnea Index (AHI)
Time Frame: 6 years
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.
6 years
Eosinophil count
Time Frame: 6 years
The investigator will refer to the Sleep Disordered Breathing Clinic records to compare Eosinophil count in patients with and without asthma.
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Julie Dawson

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2021

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

October 25, 2019

First Submitted That Met QC Criteria

October 25, 2019

First Posted (Actual)

October 29, 2019

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 269072

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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