Complete Vocal Technique Voice Therapy for Muscle Tension Dysphonia (CVT4MTD)

NCT05365126 | Completed

• 1 other identifier: 19ET004
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This proof-of-concept study is designed to evaluate whether a pedagogic technique used to help performers, known as the Complete Vocal Technique (CVT), can be used to help patients with a type of voice disorder known as Muscle Tension Dysphonia (MTD). MTD is responsible for up to 40% of patients presenting with voice and throat complaints. MTD is due to inefficient or ineffective voice production resulting from an imbalance in the control of the breathing mechanism, and uncontrolled constriction of the muscles in the larynx (voice box) or vocal tract (throat space above the vocal cords). Standard treatment is Voice Therapy delivered by a specialist Speech Therapist (SLT-V) often using a video link (telepractice aka telehealth). CVT is widely used in Europe by singers and vocal coaches. Practitioners (CVT- Ps) undergo a three-year accredited training programme, and the systematic and structured approach helps healthy singers and other performers optimise the function of the voice to produce any sound required. It also helps if the performer has vocal problems, which are also mainly due to uncontrolled throat constrictions. The purpose of this pilot study is to see if the CVT voice therapy approach (CVT-VT) can help, and offers advantages, to standard SLT-V methods in the treatment of patients with MTD. Ten adult patients will be recruited from the Voice clinic at Nottingham University Hospital. Participants will have a multidimensional assessment using questionnaires, and voice recordings and then receive up to 6 video sessions of CVT-VT delivered using a video link by a CVT-P. The participants will then be reviewed back in clinic at 8 weeks and be reassessed, using further questionnaires and analysis of the voice pre- and post-therapy recordings, to evaluate the outcome of this treatment approach. Qualitative methodology will determine whether CVT-VT offers any therapeutic advantages to existing SLT-VT treatment methods.

Conditions

Muscle Tension Dysphonia

Keywords

Muscle Tension Dysphonia; Voice Therapy; Pilot study

Outcome Measures

Primary Outcomes (1)

• Voice Handicap Index (VHI)

  Questionnaire to evaluate patient's self-reported perception of the impact of his or her voice disorder

  Eight weeks

Secondary Outcomes (9)

• Patient Experience Feedback Form: Achievement of specific goals

  Eight weeks

• Patient Experience Feedback Form: Experience of therapy

  Eight weeks

• CVT Practitioner Experience Feedback Form: Achievement of specific goals

  Eight weeks

• CVT Practitioner Experience Feedback Form: Experience of therapy

  Eight weeks

• Feedback form: use of the video link

  Eight weeks

Other Outcomes (1)

• Qualitative comparison of the specific techniques used by the CVT Practitioner compared to standard Speech Therapy techniques

  Eight weeks

Study Arms (1)

Complete Vocal Technique Voice Therapy

EXPERIMENTAL

Up to six 45 minute sessions delivered by a CVT Practitioner using a video link within an eight week therapy period

Behavioral: Complete Vocal Technique Voice Therapy

Interventions

Complete Vocal Technique Voice Therapy BEHAVIORAL

A Complete Vocal Technique (CVT) Practitioner will assess the patient's voice and voice problems using the CVT framework and then apply CVT therapy, a form of voice therapy

Also known as: CVT-VT

Complete Vocal Technique Voice Therapy

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of primary Muscle Tension Dysphonia (MTD) based on history and laryngoscopic assessment (Type (I-III) MTD pattern) through joint assessment by a SLT-V and laryngologist
• Current voice problems, persistent for greater than 2 months
• Severity of disorder a) Voice Handicap Index (VHI) ≥ 30 and b) patient wants therapy
• Patient willingness to undergo treatment
• Consent to participate in study protocol

You may not qualify if:

• Organic vocal pathology 1) Structural/neoplastic disorders (e.g. carcinoma, cyst, polyp, papilloma, Reinke's oedema); 2) neurological disorders (e.g. vocal cord palsy, paresis, spasmodic dysphonia); 3) inflammation (e.g. infection, reflux (RFS \>7) or significant relevant systemic disease (e.g. severe Chronic Obstructive Pulmonary Disease) or need for surgery
• Significant psychological issues identified during initial assessment (with option to withdraw if discovered during the treatment periods and agreed by both patient and Therapist)
• MTD pattern (IV-VI) compatible with significant primary psychological aetiology on laryngoscopy
• Transgender voice issues
• Previously incompletely treated dysphonia, neurological disease, or upper aerodigestive tract malignancy Had previous Voice Therapy (VT) or CVT training or pharmacological treatment for their voice problem - (other than proton pump inhibitors or an alginate recommended for disorders of laryngopharyngeal reflux-related symptoms)
• A hearing impairment that would prohibit or impact on telepractice treatment
• Significant concomitant health problems affecting voice
• Not have or be able to use a computer with video link at home or in hospital even with support

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead
• Innovation Fund Denmark: collaborator

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (2)

• McGlashan J, Aaen M, White A, Saccente-Kennedy B, Tempesta M, Sadolin C. Feasibility and Acceptability of Complete Vocal Technique-Voice Therapy as a Treatment for Primary Muscle Tension Dysphonia: A Feasibility Trial. J Voice. 2025 Sep 4:S0892-1997(25)00308-X. doi: 10.1016/j.jvoice.2025.07.044. Online ahead of print.

  PMID: 40913007 DERIVED

• McGlashan J, Aaen M, White A, Sadolin C. A mixed-method feasibility study of the use of the Complete Vocal Technique (CVT), a pedagogic method to improve the voice and vocal function in singers and actors, in the treatment of patients with muscle tension dysphonia: a study protocol. Pilot Feasibility Stud. 2023 May 24;9(1):88. doi: 10.1186/s40814-023-01317-y.

  PMID: 37226281 DERIVED

Related Links

• Protocol publication

Study Officials

• Julian A McGlashan, FRCS(Otol.)

  Nottingham University Hospitals

  PRINCIPAL INVESTIGATOR

• Cathrine Sadolin

  Complete Vocal Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot/feasibility Cohort study

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 9, 2022
• Study Start: May 5, 2022
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)