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Bruni® Training in OPHL Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06058273
Acronym
BTLS
Enrollment
20
Registered
2023-09-28
Start date
2023-10-01
Completion date
2024-04-30
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substitution Voice

Brief summary

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.

Interventions

BEHAVIORALBruni® training

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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Maximum phonation time3 monthsemit 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
type of spectrogram3 monthsA sustained /a/ will be recorded, subsequently analyzed with the PRAAT software.
foundamental frequency3 monthsA sustained /a/ will be recorded, subsequently analyzed with the PRAAT software
Formantic peaks3 monthsThe dysillabic word /papà/ will be recorded, subsequently analyzed with the PRAAT software
perceptual evaluation3 monthsVoices 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.
self evaluation of voice3 monthsPatients 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026