Evaluating the Feasibility of Acapella® Choice as a Dysphonia Treatment

NCT04764604 | Completed Results FDA Device

• 1 other identifier: 18/0434
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID)

  A quantitative, multivariate, dysphonia summary tool that incorporates spectral (low/high spectral ratio) and cepstral measures (cepstral peak prominence), and their standard deviations, extracted from a continuous speech or sustained vowel sample utilising the software Analysis of Dysphonia in Speech and Voice (Kay Pentax, Montvale, NJ). The software calculates CSID on the scale of 0-100, whereby 0 represents no evidence of hoarse voice, and 100 represents a maximum amount of hoarseness. See: Awan SN, Roy N, Dromey C. Estimating dysphonia severity in continuous speech: Application of a multi-parameter spectralcepstral model estimating dysphonia severity in continuous speech. Clinical Linguistics and Phonetics. 2009;23(11):825-841. doi:10.3109/02699200903242988.

  Immediately after 3 minutes of exercise

Secondary Outcomes (7)

• Change in Baseline Sound Pressure Level (dB)

  Immediately after 3 minutes of exercise

• Change in Baseline Mean Contact Quotient

  During 3 minutes of exercise (continual) and immediately following exercise.

• Change in Subglottic Pressure

  During 3 minutes of exercise (continual)

• Transglottic Airflow

  During 3 minutes of exercise (continual)

• Change in Baseline Laryngeal Resistance

  Immediately after 3 minutes of exercise

Study Arms (3)

Muscle Tension Group

EXPERIMENTAL

10 participants with a diagnosis of muscle tension dysphonia will carry out two experimental interventions, with a 30 minute vocal rest period in between interventions: 1. Three minutes of semi-occluded vocal tract exercise with both Acapella Choice 2. Three minutes of tube-in-water semi-occluded vocal tract exercise. Aerodynamic, acoustic and electroglottographic baselines will be taken before each intervention and repeated immediately post-intervention as outcomes. Participants will also provide a self-assessment of voice quality, perceived ease of voice production and perceived strength of voice before and after each intervention. Participants will additionally answer qualitative questions following each intervention regarding their perceptions of the task: ease performing, pleasantness, effort, practicality and likelihood of carrying out the task on a daily basis as a form of therapy.

Device: Acapella Choice; Device: Tube-in-water

Vocal Fold Palsy Group

EXPERIMENTAL

10 participants with a diagnosis of (unilateral) vocal fold palsy will carry out two experimental interventions, with a 30 minute vocal rest period in between interventions: 1. Three minutes of semi-occluded vocal tract exercise with both Acapella Choice 2. Three minutes of tube-in-water semi-occluded vocal tract exercise. Aerodynamic, acoustic and electroglottographic baselines will be taken before each intervention and repeated immediately post-intervention as outcomes. Participants will also provide a self-assessment of voice quality, perceived ease of voice production and perceived strength of voice before and after each intervention. Participants will additionally answer qualitative questions following each intervention regarding their perceptions of the task: ease performing, pleasantness, effort, practicality and likelihood of carrying out the task on a daily basis as a form of therapy.

Device: Acapella Choice; Device: Tube-in-water

Presbylaryngis Group

EXPERIMENTAL

10 participants with a diagnosis of presbylaryngis will carry out two experimental interventions, with a 30 minute vocal rest period in between interventions: 1. Three minutes of semi-occluded vocal tract exercise with both Acapella Choice 2. Three minutes of tube-in-water semi-occluded vocal tract exercise. Aerodynamic, acoustic and electroglottographic baselines will be taken before each intervention and repeated immediately post-intervention as outcomes. Participants will also provide a self-assessment of voice quality, perceived ease of voice production and perceived strength of voice before and after each intervention. Participants will additionally answer qualitative questions following each intervention regarding their perceptions of the task: ease performing, pleasantness, effort, practicality and likelihood of carrying out the task on a daily basis as a form of therapy.

Device: Acapella Choice; Device: Tube-in-water

Interventions

Acapella Choice DEVICE

3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.

Also known as: PEP, Semioccluded vocal tract exercise

Muscle Tension Group; Presbylaryngis Group; Vocal Fold Palsy Group

Tube-in-water DEVICE

3 minutes of exercise consisting of blowing through a silicone tube (10mm internal diameter) submerged in 5 cm of water whilst phonating at the same time.

Also known as: Lax Vox, Resonance tube in water, Semi-occluded vocal tract exercise

Muscle Tension Group; Presbylaryngis Group; Vocal Fold Palsy Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• Smiths Medical, ASD, Inc.: collaborator

Study Sites (1)

Royal National ENT Hospital, UCLH Hospitals NHS Trust

London, NW1 2PG, United Kingdom

Location

Related Publications (22)

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  PMID: 26526005 BACKGROUND

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  BACKGROUND

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MeSH Terms

Conditions

Vocal Cord Paralysis; Dysphonia

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Voice Disorders

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation

Results Point of Contact

• Title: Brian Saccente-Kennedy, Speech and Language Therapist
• Organization: University College London Hospitals NHS Foundation Trust

brian.saccente-kennedy@nhs.net

+44 20 3456 5180

Study Officials

• Brian Saccente-Kennedy, MSc

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: February 21, 2021
• Study Start: December 14, 2020
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)