N/A
N=30
Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment
Muscle Tension Dysphonia · Vocal Fold Palsy · Vocal Cord Paralysis · Presbylarynx · Dysphonia
Bottom Line
View on ClinicalTrials.gov: NCT04764604 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID) — 1.22; 4.45; 4.56; 3.13 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acapella Choice (Device); Tube-in-water (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University College, London
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID) |
1.22; 4.45; 4.56; 3.13 | — |
| SECONDARY Change in Baseline Sound Pressure Level (dB) |
0.79; 1.46; 1.57; -0.52 | — |
| SECONDARY Change in Baseline Mean Contact Quotient |
0.01; -0.01; 0.01; 0.00 | — |
| SECONDARY Change in Subglottic Pressure |
0.16; 0.95; -0.74; -0.68 | — |
| SECONDARY Transglottic Airflow |
0.017; 0.023; -0.011; -0.003 | — |
| SECONDARY Change in Baseline Laryngeal Resistance |
1.40; -6.01; -5.04; 23.77 | — |
| SECONDARY Change in Baseline Perceptual Voice Quality |
-1.82; 0.175; 0.622; 5.18 | — |
| SECONDARY Change in Baseline Participant Self-ratings - Voice Quality |
12.3; 4.62; 6.56; 1.38 | — |
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 Choice as a form of semioccluded vocal tract exercise (SOVTE).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04764604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.