CClinicalTrials.gg
Not yet recruitingNCT06058273BTLSUpdated Sep 28, 2023

Bruni® Training in OPHL Patients

An interventional study of Bruni® training in Substitution Voice, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Substitution Voice
03

In context

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • \< 1 year from the end of both surgical and radiotherapy treatment;
  • presence of disease recurrence;
  • sensory, neurological deficits
  • Learning disabilities
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    OPHL patients

    Behavioral: Bruni® training

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

  2. type of spectrogram

    A sustained /a/ will be recorded, subsequently analyzed with the PRAAT software.

    Time frame: 3 months

  3. foundamental frequency

    A sustained /a/ will be recorded, subsequently analyzed with the PRAAT software

    Time frame: 3 months

  4. Formantic peaks

    The dysillabic word /papà/ will be recorded, subsequently analyzed with the PRAAT software

    Time frame: 3 months

  5. 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.

    Time frame: 3 months

  6. 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.

    Time frame: 3 months

07

Study locations

1 site
  • Fondazione Policlinico Universitario A. Gemelli - IRCCS
    Roma, 00168, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06058273
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
LONGOBARDI YLENIA (Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Sep 28, 2023
Start date
Oct 1, 2023 (estimated)
Primary completion
Jan 1, 2024 (estimated)
Completion
Apr 30, 2024 (estimated)
Last update
Sep 28, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion