Feasibility of Constant Work Rate Testing to Detect Exercise-induced Laryngeal Obstruction

TITLE Feasibility of constant work rate testing to detect exercise-induced laryngeal obstruction

DESIGN Prospective observational pilot study

AIMS To investigate if constant work rate testing at different work rates will sufficiently induce detectable exercise-induced laryngeal obstruction (EILO) using CLE.

POPULATION Adult patients with EILO

DURATION 01.09.2022 - 30.06.2023

Study Overview

• Status: Recruiting
• Conditions: Exercise-induced Laryngeal Obstruction (EILO)
• Intervention / Treatment: Diagnostic test: Continuous laryngoscopy during exercise (CLE), incremental exercise protocol; Diagnostic test: Continuous laryngoscopy during exercise (CLE), continuous work rate protocol

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Emil Walsted, MD, PhD; Phone Number: +4530338750; Email: emil.ingerslev.walsted@regionh.dk
• Study Contact Backup: Name: Jens T Pedersen, BSc; Phone Number: +4529422843; Email: jens.thougaard.pedersen@gmail.com

Study Locations

• Denmark
  • Region Hovedstaden
    • København NV, Region Hovedstaden, Denmark, 2400
      • Recruiting
      • Bispebjerg Hospital
      • Contact: Emil Ingerslev Walsted, MD, PhD; Phone Number: +4530338750; Email: emil.ingerslev.walsted@regionh.dk
      • Contact: Jens Thougaard Pedersen, B.Sc; Phone Number: +4529422843; Email: jens.thougaard.pedersen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals referred to CLE testing at the asthma service at Bispebjerg Hospital in Copenhagen, Denmark, for the investigation of exercise-related respiratory symptoms, will be offered to participate in the present study in addition to the standard-of-care incremental CLE test.

Al patients will be evaluated during the visit to the asthma service at Bispebjerg Hospital to ensure they are clinically fit for exercise testing.

Description

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 or above with a clinical suspicion of having EILO.
• Individuals with concurrent asthma can participate in the study provided that their asthma is well-controlled, determined by a negative bronchoprovocation test.

Exclusion Criteria:

• No EILO found in Clinical standard-of-care CLE test
• Not able to complete the exercise test for other reasons than breathlessness or leg fatigue (e.g. injury, disease or disability preventing cycling to maximal exertion).
• Comorbidities other than asthma, which, judged by the investigator, might confound the test results or pose a medical risk to the patient (e.g. cardiac disease, exercise-induced anaphylaxis).
• Current smokers (< 6 months of stopping) or individuals with a significant smoking history (>10 pack years).
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence and degree of glottic or supraglottic collapse in EILO patients	Laryngoscopic detection of supraglottic or a glottic obstruction of the same severity as observed during incremental testing, during a submaximal constant work rate exercise test (70 %, 80 % and 90 %) using a visual grade scale (0-3, with 0 reflecting no obstruction, and 3 being the most severe degree of obstruction).	Changes from baseline during the procedure and immediately after cessation of the exercise test.
Time of onset of the laryngeal obstruction	A specific point in time where observed laryngeal obstruction is first discernible will be determined during the evaluation of the laryngoscopic videos. This is to descriptively quantify this outcome.	A time of onset determined during the procedures
Observed duration of the laryngeal obstruction	The investigators will further evaluate the laryngoscopic videos and determine the duration of the participant's laryngeal obstruction. This duration is defined as the time period from the time of onset during submaximal exercise, until remission of the observed obstruction or end of the test.	Duration measured in seconds during the procedures

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported symptom score: Dyspnoea-12	The patients will fill out the Dyspnoea-12 questionnaire before the first exercise test The questionnaire consists of 12 questions regarding dyspnoea. This is a descriptive measure	At baseline
Patient reported symptom scores: Nijmegen	The participants will fill out the Nijmegen questionnaire before the first exercise test The questionnaire consists of 16 questions, with answers ranging from "never" to "very often". A score is calculated from these answers. A higher score means that it is more likely that the participant suffers from hyperventilation syndrome. This is a descriptive measure	At baseline
Patient reported symptom scores: Multidimensional Dyspnoea Profile (MDP).	The patients will fill out the Multidimensional Dyspnoea Profile (MDP) questionnaire before the first exercise test This profile consists of questions regarding both affective and sensory components of dyspnoea. This is a descriptive measure	At baseline
Modified borg dyspnoea during exercise	Minimum score: 0 Maximum score: 10 The participant will be asked to rate dyspnoea at baseline and during the CLE tests at 1 minute intervals. The investigators will compare the scores between the incremental CLE tests and the constant work rate CLE tests.	At baseline and at one minute intervals during the CLE tests (up to 60 minutes)
Leg fatigue scores during exercise	Minimum score: 0 Maximum score: 10 The participant will be asked to rate leg fatigue at baseline and during the CLE tests at 1 minute intervals. The investigators will compare the scores between the incremental CLE tests and the constant work rate CLE tests.	At baseline and at one minute intervals during the CLE tests (up to 60 minutes)
Rate of perceived exertion (RPE) scores during exercise	Minimum score: 0 Maximum score: 10 The participant will be asked to evaluate their rate of perceived exertion at baseline and during the CLE tests at 1 minute intervals. The investigators will compare the scores between the incremental CLE tests and the constant work rate CLE tests.	At baseline and at one minute intervals during the CLE tests (up to 60 minutes)
Inter-rater agreement of the prevalence and degree of glottic or supraglottic collapse in EILO patients	After obtaining laryngoscopic video data, the investigators will evaluate the severity of laryngeal obstruction using a visual grade scale (0-3). From these gradings we will calculate inter-rater agreement values (weighted kappa).	During data analysis (month 1).

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: H-20057391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No