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NCT05189600: SETTLE
Can Waveform and Flow Traces From Mechanical Insuflattion:Exsufflation (MI:E) be Used to Identify Laryngeal Responses to MI:E and Thus Optimise Treatment Algorithms?
trial testing Mechnical Insufflation:Exsufflation in Neuromuscular Diseases in 20 participants. Currently enrolling.
1 January 2025
Quick facts
| Lead sponsor | Royal Free Hospital NHS Foundation Trust |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 1 January 2022 |
| Primary completion | 1 January 2025 |
| Estimated completion | 1 January 2025 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Mechnical Insufflation:Exsufflation
Conditions studied
- Neuromuscular Diseases — all drugs for Neuromuscular Diseases →
Sponsor
Royal Free Hospital NHS Foundation Trust
Who can join
18 and older, any sex, with Neuromuscular Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Objectives: * To establish if physiotherapists can use the waveform traces from the cough assist machine to work out when patients are having an abnormal airway response to cough assist * To establish how cough assist device settings, particularly in breath and cough pressures affect a patient's response to using the cough assist device * To provide some clinical guidance to physiotherapists on methods for assessing and treating abnormal airway responses to cough assist devices Methodology: Subjects will complete breathing tests; spirometry, peak cough flow (PCF) and sniff nasal inspiratory pressure (SNIP) to establish baseline breathing function and rule out anyone with breathing conditions. A nasal camera will be used to look at the voice box at rest. Cough assist will be delivered via a face mask which will allow for simultaneous use of the nasal camera and cough assist carried out in the same way as another research team have done previously. The nasal camera will be attached to a video camera to allow recording, analysis and documentation of the observations. The cough assist protocol will be delivered by a physiotherapist experienced in delivering cough assist. Cough assist waveforms will be downloaded into Care Orchestrator software (Philips Respironics, Murraysville, USA) and reviewed at the same time as the nose camera recordings to establish if voice box responses can be identified from the waveform patterns. For confirmation of Care Orchestrator software waveforms, a device that records airflow during breathing (spirometer) will be connected (Alpha touch, Vitalograph, Ennis, Ireland) into the cough assist circuit in the same way another research team has before.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pilot observational cohort study to determine whether waveform and flow traces from mechanical insufflation-exsufflation (MI-E) can be used to identify laryngeal responses to MI-E and thus optimise treatment algorithms in neuromuscular patients in a tertiary centre: a protocol de
Mansell SK, Parry R, Shah A, Gowing F, et al · · 2024 · cited 1× · PMID 38460974 · DOI 10.1136/bmjresp-2022-001599
Verify or expand the search:
- PubMed search for NCT05189600
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Royal Free Hospital NHS Foundation Trust trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05189600 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Royal Free Hospital NHS Foundation Trust
- Last refreshed: 13 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05189600.
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