Status:
COMPLETED
Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment
Lead Sponsor:
University College, London
Collaborating Sponsors:
Smiths Medical, ASD, Inc.
Conditions:
Muscle Tension Dysphonia
Vocal Fold Palsy
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
A feasibility study to identify the immediate effect on the voices of patients with voice disorders (muscle tension dysphonia, vocal fold palsy or presbylaryngis) produced by exercising with Acapella ...
Detailed Description
This feasibility study is the natural extension of the researchers' recently completed study (R\&D 16/0242) which assessed how the use of an Acapella Choice (Smiths Medical) positive expiratory pressu...
Eligibility Criteria
Inclusion
- Able to understand written English without the need for an interpreter,
- No diagnosed communication impairment
- Endoscopically confirmed primary ENT diagnosis of either:
- muscle tension dysphonia (with no laryngeal abnormality),
- Vocal fold palsy
- Presbylaryngis.
Exclusion
- Previous SLT input
- Any of the following possible contraindications for PEP therapy:
- Inability to tolerate increased work of breathing,
- ICP (intracranial pressure) \> 20mm Hg,
- Recent facial/oral/skull surgery or trauma,
- Oesophageal surgery,
- Untreated pneumothorax,
- Known or suspected tympanic membrane rupture/other middle ear pathology,
- Haemodynamic instability,
- Acute sinusitis,
- Epistaxis,
- Active haemoptysis,
- Nausea
Key Trial Info
Start Date :
December 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04764604
Start Date
December 14 2020
End Date
November 29 2021
Last Update
August 1 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal National ENT Hospital, UCLH Hospitals NHS Trust
London, United Kingdom, NW1 2PG