Bruni® Training in OPHL Patients

Study Overview
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Brief Summary
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Surgically treated patients with type II OPHL being treated at the Phoniatrics Unit of the Fondazione Policlinico Universitario A. Gemelli-IRCCS, but not satisfied with their voice after the first cycle of therapy with a standard rehabilitation approach, will be recruited. To interested patients, a specific vocal rehabilitation program based on Bruni training will be proposed in order to compare the results obtained using this method with those following the previous treatment.

Official Title
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Improvement of the Phonatory Outcome in Patients Undergoing Open Partial Horizontal Laryngectomy (OPHL) and Speech Therapy by Applying the Bruni® Training: a Prospective Cohort Study

Conditions
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Substitution Voice

Intervention / Treatment
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* Behavioral: Bruni® training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18; Italian mother tongue; ability to produce the replacement voice; ability to provide written informed consent Exclusion Criteria: < 1 year from the end of both surgical and radiotherapy treatment; presence of disease recurrence; sensory, neurological deficits Learning disabilities

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPHL patients<br> | Behavioral: Bruni® training<br>* 10 sessions (7 individual and 3 group) based on the Bruni method, which was born as a method for the artistic voice (rock, pop, gospel, R&B, grunge, metal), acting and dubbing. It is a method based on the didactic desire to lead any artist to the ability to produce various types of noise, specifically generically supraglottic, predominantly arytenoid and falsechordal emissions, providing the perceptive, proprioceptive and praxis tools to safely emit and manage the many sounds generated from a supraglottic source<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum phonation time | emit a sustained /a/ for as long as possible with a single air intake. The test will be repeated three times and the longest of the three attempts will be calculated as MPT | 3 months | 
| type of spectrogram | A sustained /a/ will be recorded, subsequently analyzed with the PRAAT software. | 3 months | 
| foundamental frequency | A sustained /a/ will be recorded, subsequently analyzed with the PRAAT software | 3 months | 
| Formantic peaks | The dysillabic word /papà/ will be recorded, subsequently analyzed with the PRAAT software | 3 months | 
| perceptual evaluation | Voices will be perceptually rated by expert clinicians using the INFVo scale which includes overall impression (I), amount of unintentional additive noise (N), fluency (F) and voice quality (Vo). For each parameter the score can vary from 0 to 10. The higher the score, the better the perceived voice quality. | 3 months | 
| self evaluation of voice | Patients will be administered the self-evaluation questionnaire Self-evaluation of Communicative Experience after Laryngeal cancer which measures adaptation to the replacement voice through 35 items in three subscales (General, Environment, Attitude). Patients should rate each statement on a 4-point categorical scale. You can get a total score from 0 to 102 and three subscores. A score ≥60 suggests the need for specific psychological intervention for acceptance of the new voice. | 3 months |