Presbyphonia Signs and Symptoms
Conditions
Interventions
This study is a non-randomised multicentre feasibility trial of CLEARER Voice Group mechanisms of action. The trial will run at UCLH and three additional NHS sites (Guy's Hospital, Charing Cross Hospi
Sponsors
University College London Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
50 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. 50 years of age or older 2. ENT consultant-confirmed diagnosis of presbyphonia 3. Laryngeal images from most recent (within 6 months) ENT exam available for analysis 4. Typical hearing (as indicated by hearing screening at 40 dB HL at 500, 1000, and 1500 Hz, bilaterally), wearing hearing aids (if applicable) 5. Comfortable using spoken English in a group conversation setting 6. Willing and able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Recent (< 12 months) voice therapy 2. Current diagnosis of a neurological condition affecting laryngeal or respiratory function (i.e., Parkinson’s disease, CVA, spasmodic dysphonia) 3. Current diagnosis of additional laryngeal pathology 4. Contraindicated for spirometry (haemoptysis of unknown origin, pneumothorax, unstable cardiovascular status, ‘recent’ (< 6 weeks) myocardial infarction or pulmonary embolus , thoracic/abdominal/cerebral aneurysms, ‘recent’ (<6 weeks) eye surgery, nausea/vomiting, ‘recent’ (<6 weeks) thoracic/abdominal surgery) 5. Contraindicated for PEEP (haemodynamic instability (caused by cardiogenic shock, recent myocardial infarction, left heart failure, hypovolaemia), severe hypotension, severe COPD/asthma, raised intracranial pressure, diagnosis of an air leak syndrome (i.e., bronchopleural fistula) or unilateral lung disease) 6. Failing cognitive screen (scoring <23 on the Rowland Universal Dementia Assessment Scale [RUDAS])
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient and clinician acceptability of intervention measured using the Theoretical Framework of Acceptability Questionnaire at post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate measured using the percentage of eligible participants who provide informed consent and are enrolled in the trial at pre-treatment 2. Intervention dose received measured using the percentage of recruited participants who attend at least 5 of 6 CLEARER Voice Group sessions recorded in attendance logs at post-treatment 3. Acceptability of trial procedures measured using the Modified Theoretical Framework of Acceptability Questionnaire at post-treatment 4. Clinician treatment fidelity measured using the percentage of prescribed session components delivered by each treating clinician recorded in clinician fidelity records at post-treatment 5. Adherence to home practice measured using the percentage of prescribed daily home practice completed by participants recorded in home practice tracking logs from session 2 to session 6 6. Group climate measured using the Group Climate Questionnaire Short Form (GCQ-S) at post-treatment 7. Voice-related quality of life measured using the Aging Voice Index (AVI) at pre-treatment and post-treatment 8. Self-rated voice function measured using visual analogue scales at pre-treatment and post-treatment 9. Vocal tract discomfort measured using the Vocal Tract Discomfort Scale (VTDS) at pre-treatment and post-treatment 10. Voice quality measured using the Acoustic Voice Quality Index (AVQI) at pre-treatment and post-treatment 11. Perceptual voice severity measured using the Overall Severity domain of the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) at pre-treatment and post-treatment 12. Speech breathing kinematics measured using lung volume initiation (LVI) during extemporaneous speech at pre-treatment and post-treatment 13. Laryngeal aerodynamics measured using laryngeal resistance; glottal airflow; estimated subglottic pressure at pre-treatment and post-treatment 14. Respiratory muscle strength measured using maximum inspiratory pressure (MIP); maximum expiratory pressure (MEP) at pre-treatment and post- | — |
Countries
England, United Kingdom
Contacts
Public ContactBrian Saccente-Kennedy
Outcome results
None listed