Development of a standardised non-medical treatment for inducible laryngeal obstruction
| ISRCTN | ISRCTN18291587 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18291587 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 335820 |
| Protocol serial number | IRAS 335820, Sponsor reference NHS002135 |
| Sponsor | University of Manchester |
| Funders | Manchester Biomedical Research Centre, North West Lung Centre Charity |
- Submission date
- 23/01/2024
- Registration date
- 25/01/2024
- Last edited
- 25/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
Inducible laryngeal obstruction (ILO) is when the larynx (voice box) inappropriately closes. This leads to breathing difficulties and individuals may seek help from primary care, emergency departments or need to be admitted to hospital. Currently there is no standard approach to treat ILO once it is diagnosed. Non-pharmacological interventions (treatment without medication) are often recommended and used in the clinical setting but is not yet known what the possible key components of non-pharmacological interventions are and whether they are acceptable to individuals with ILO. The aim of this study is to develop and describe a non-pharmacological standardised intervention for adults with ILO.
Who can participate?
1. Healthcare professionals experienced in assessing, diagnosing and delivering non-pharmacological interventions to adults with ILO (defined as holding a regular ILO caseload of >3 years)
2. Patients aged over 18 years with an established diagnosis of ILO based on clinical evaluation and endoscopic visualisation of laryngeal obstruction during a symptomatic episode.
What does the study involve?
It will be in three phases:
Stage 1: A 60-90-minute focus group with 5-7 health care professionals will be held virtually. It will explore attitudes and beliefs on the timing of ILO intervention, how much should be given, how and what should be delivered. The meeting will be transcribed and analysed for any themes.
Stage 2: One-to-one (30-45 minutes) interviews with 20-27 patients diagnosed with ILO, will explore patient opinion on interventions. An interview guide will be developed based on Stage 1. The meetings will be held virtually, transcribed, and then analysed. Following analysis, a draft of a standardised non-pharmacological intervention for adults with ILO will be prepared.
Stage 3: The draft manual will be shown to participants from Stages 1 and 2, together with a questionnaire to check for content, understanding and acceptability. Based on feedback, any required changes will be made and a final manual produced.
What are the possible benefits and risks of participating?
Taking part in the study will have no direct benefit to participants. There are no identified significant risks to taking part. The study will not explore patients' experience of living with ILO.
Where is the study run from?
University of Manchester (UK)
When is the study starting and how long is it expected to run for?
September 2023 to December 2024
Who is funding the study?
1. Manchester Biomedical Research Centre (UK)
2. North West Lung Centre Charity (UK)
Who is the main contact?
Jemma Haines, jemma.haines@mft.nhs.uk
Contact information
Public, Principal investigator
Manchester University NHS Foundation Trust
2nd Floor Education and Research Centre
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
 ORCID ID |
0000-0003-3813-041X |
|---|---|
| Phone | +44 (0)161 2914245 |
| jemma.haines@mft.nhs.uk |
Scientific
Manchester University NHS Foundation Trust
2nd Floor Education and Research Centre
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
| ORCID ID |
0000-0002-4524-1663 |
|---|---|
| Phone | +44 (0)1612914245 |
| stephen.fowler@manchester.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre qualitative interview and questionnaire study |
| Secondary study design | Qualitative study |
| Study type | Participant information sheet |
| Scientific title | Inducible Laryngeal Obstruction in adults: developing a standardised non-pharmacological Intervention |
| Study acronym | ILO-i |
| Study objectives | Currently there is no standard approach to treat Inducible Laryngeal Obstruction (ILO) once it is diagnosed. There are no licenced medications available and non-pharmacological interventions (treatment without medication) are often recommended in a clinical setting. The purpose of this research is to understand what the possible key components of non-pharmacological interventions are and whether they are acceptable to individuals with ILO. |
| Ethics approval(s) |
Approved 15/02/2024, North West Greater Manchester South (3rd Floor, Barlow House, 4 Minshull Street, HRA NRES Centre, Manchester, M1 3DZ, United Kingdom; +44 (0)20711048014; gmsouth.rec@hra.nhs.uk), ref: 24/NW/0010 |
| Health condition(s) or problem(s) studied | Inducible Laryngeal Obstruction in adults |
| Intervention | Stage 1: A 60-90 minutes focus group (with 5-7 experienced health care professionals experienced in delivering non-pharmacological interventions to adults with ILO) Stage 2: One-to-one (30-45 minutes) interviews with 20-27 patients diagnosed with ILO Stage 3: The draft manual will be shown to participants from Stage 1 and 2, together with a bespoke questionnaire to check for content, clarity and acceptability. Based on feedback, any required changes will be made and a final manual produced. |
| Intervention type | Other |
| Primary outcome measure(s) |
Participant opinions/responses (variable) to questions regarding non-pharmacological interventions for ILO will be measured in a focus group/interview at a single timepoint using data transcript thematic analysis |
| Key secondary outcome measure(s) |
Participant responses (variable) to a debriefing questionnaire on a draft standardised treatment manual for ILO will be measured at a single timepoint using thematic analysis |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 34 |
| Key inclusion criteria | Healthcare professionals: 1. Experienced (defined as holding a regular ILO caseload for >3 years) in assessing, diagnosing and delivering nonpharmacological treatment to adults with ILO Treatment naïve patients: 1. An established diagnosis of ILO based on i) clinical evaluation AND ii) endoscopic visualisation of laryngeal obstruction during a symptomatic episode 2. >18 years old 3. Have not received and completed non-pharmacological / behavioural therapy intervention for ILO Post-treatment patients: 1. An established diagnosis of ILO based on i) clinical evaluation and ii) endoscopic visualisation of laryngeal obstruction during a symptomatic episode 2. >18 years old 3. Have received and completed a non-pharmacological behavioural therapy intervention for ILO |
| Key exclusion criteria | Healthcare professionals: 1. Healthcare professionals who have no specialist experience in assessing, diagnosing and delivering nonpharmacological treatment to adults with ILO Treatment naïve patients: 1. Have received any previous therapy intervention for ILO, refractory chronic cough or upper airway symptoms (e.g. muscle tension dysphonia, globus pharyngeaous) 2. Have uncontrolled asthma airway inflammation or obstruction (defined as fractional exhaled nitric oxide >50ppb, FEV1/FVC <70%) Post-treatment patients: 1. Have completed a non-pharmacological behavioural therapy intervention for ILO greater than 4 months prior to study 2. Have uncontrolled airway inflammation or obstruction (defined as fractional exhaled nitric oxide >50ppb, FEV1/FVC <70%) |
| Date of first enrolment | 01/03/2024 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Jemma Haines (jemma.haines@mft.nhs.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.3 | 19/01/2024 | 24/01/2024 | No | No |
Additional files
- 44931_PROTOCOL_v1.3_19Jan24.pdf
- Protocol file
Editorial Notes
25/10/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/10/2024 to 31/12/2024.
2. The overall study end date was changed from 31/10/2024 to 31/12/2024.
08/03/2024: The ethics approval was added.
07/02/2024: Internal review.
24/01/2024: Study's existence confirmed by the HRA.
