Clinical trial NCT04764604: Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment
Official title: Evaluating the Therapeutic Use of a Vibratory Positive Expiratory Pressure Device (Acapella® Choice) in the Treatment of Pathological Voice - A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Tension Dysphonia
Vocal Fold Palsy
Vocal Cord Paralysis
Presbylarynx
Dysphonia
Keywords: semi-occluded vocal tract exercise
positive expiratory pressure
tube phonation
Acapella
voice therapy
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Smiths Medical, ASD, Inc.
First posted: 2021-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a feasibility study using a 'before and after' design to test the immediate effects of exercising with Acapella Choice in comparison to the immediate effects of exercising with Tube-in-water resistance exercises (current treatment norm). Participants will be assigned groups according to their diagnosis (i.e. muscle tension group, vocal fold palsy group and presbylaryngis group). All participants will exercise with both techniques (i.e. Acapella and tube-in-water).
Primary purpose: TREATMENT

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 Choice as a form of semioccluded vocal tract exercise (SOVTE).

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 pressure (PEP) device as a semi-occluded vocal tract exercise (SOVTE) impacted acoustic, electroglottographic and aerodynamic measures of the voice in a group of normophonic volunteers. In that study, Acapella Choice was found to offer significantly greater oscillating intraoral pressures than techniques in current clinical practice and was found to have measurable benefits in terms of producing a louder and more economical voice. It offered the largest oscillating pressures, likened to a 'massage' of the vocal organs, giving it great therapeutic promise for patients with excess vocal tract tension.

This study seeks to evaluate the immediate effects of Acapella Choice as a voice exercise in patients with Muscle Tension Dysphonia, Presbylaryngis and Vocal Fold Palsy, and compare this to the widely-used voice rehabilitation technique of phonation into a tube held under water (henceforward referred to as "Tube"). Patients will be recruited from four weekly Voice Clinics held at the Royal National Throat Nose and Ear Hospital where their diagnosis will be confirmed. They will be invited to attend a single experimental session during which time they will exercise both with Acapella Choice and with Tube. Baseline and outcome voice measures will be taken and a short questionnaire will be completed, eliciting perceptions of the two exercises and any changes which were felt to have resulted from them.

The researchers' previous work suggests that Acapella Choice as a SOVTE may offer significant clinical benefits in terms of improved efficacy of therapy. It is suggested that it also offers patients a more convenient and user-friendly form of exercise which may well improve compliance and result in better outcomes.

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:

  1. muscle tension dysphonia (with no laryngeal abnormality),
  2. Vocal fold palsy
  3. 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

Primary outcomes:
measure: Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID)
timeFrame: Immediately after 3 minutes of exercise
Secondary outcomes:
measure: Change in Baseline Sound Pressure Level (dB)
timeFrame: Immediately after 3 minutes of exercise
measure: Change in Baseline Mean Contact Quotient
timeFrame: During 3 minutes of exercise (continual) and immediately following exercise.
measure: Change in Subglottic Pressure
timeFrame: During 3 minutes of exercise (continual)
measure: Transglottic Airflow
timeFrame: During 3 minutes of exercise (continual)
measure: Change in Baseline Laryngeal Resistance
timeFrame: Immediately after 3 minutes of exercise
measure: Change in Baseline Perceptual Voice Quality
timeFrame: Immediately after 3 minutes of exercise
measure: Change in Baseline Participant Self-ratings - Voice Quality
timeFrame: Immediately after 3 minutes of exercise
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal National ENT Hospital, UCLH Hospitals NHS Trust
Study officials:
affiliation: University College London Hospitals
name: Brian Saccente-Kennedy, MSc
role: PRINCIPAL_INVESTIGATOR
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