NCT04142905

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 10, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

4.6 years

First QC Date

October 25, 2019

Last Update Submit

December 18, 2023

Conditions

AsthmaObstructive Sleep Apnoea (OSA)Dysanapis

Outcome Measures

Primary Outcomes (1)

  • Defined dysynapsis in patients with asthma and obstructive sleep apnoea (OSA)

    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 Outcomes (2)

  • Apnea-Hypopnea Index (AHI)

    6 years

  • Eosinophil count

    6 years

Study Arms (2)

Patients With Asthma

Subjects with sleep disordered breathing with asthma

Patients Without Asthma

Subjects with sleep disordered breathing without asthma

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Any subject in Obstructive Sleep Apnea clinic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, NR4 7UY, United Kingdom

Location

Related Publications (8)

  • 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: 19912154BACKGROUND

  • 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: 25371419BACKGROUND

  • 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: 16963682BACKGROUND

  • 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: 16627866BACKGROUND

  • 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: 11641506BACKGROUND

  • 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: 26504195BACKGROUND

  • 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: 15591475BACKGROUND

  • 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.

    PMID: 27552676BACKGROUND

MeSH Terms

Conditions

AsthmaSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSleep Apnea SyndromesApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Services Manager

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 29, 2019

Study Start

February 10, 2021

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

December 22, 2023

Record last verified: 2023-12

Locations

GB(1)