ILO-i
Research type
Research Study
Full title
Inducible Laryngeal Obstruction in adults: developing a standardised non-pharmacological Intervention
IRAS ID
335820
Contact name
Jemma Haines
Contact email
Sponsor organisation
The University of Manchester
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
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 if this is effective.
The aim of this study is to develop and describe a non-pharmacological standardised intervention for adults with ILO. It will be in three phases:
Stage 1(February 2024-March 2024) – A 60-90 minutes focus group (with 5-7 experienced health care professionals experienced in delivering non-pharmacological interventions, recruited through national professional networks) 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 using thematic analysis.
Stage 2(March 2024-September 2024) – One-to-one (30-45 minutes) interviews with 20-27 patients diagnosed with ILO, will explore patient opinion on interventions. Participants will be recruited from four established UK centres that diagnose and treat ILO (Manchester University NHS Foundation Trust, Lancashire Hospitals NHS Foundation Trust, University Hospitals Birmingham NHS Foundation Trust, Sheffield teaching Hospitals NHS Foundation Trust). An interview guide will be developed based on Stage 1. The meetings will be held virtually, transcribed, and then analysed using thematic analysis. Following analysis a draft of a standardised non-pharmacological intervention for adults with ILO will be prepared.
Stage 3(September 2024-November 2024) – 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.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
24/NW/0010
Date of REC Opinion
15 Feb 2024
REC opinion
Further Information Favourable Opinion