Bruni® Training in OPHL Patients

Not Applicable

Not yet recruiting

• Conditions: Substitution Voice
• Interventions: Behavioral: Bruni® training

• Registration Number: NCT06058273
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-22
• Last Update Submitted: 2023-09-22
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Study Start: 2023-10-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OPHL patients	Bruni® training	-

Primary Outcome Measures

Name	Time	Method
Maximum phonation time	3 months	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
type of spectrogram	3 months	A sustained /a/ will be recorded, subsequently analyzed with the PRAAT software.
foundamental frequency	3 months	A sustained /a/ will be recorded, subsequently analyzed with the PRAAT software
Formantic peaks	3 months	The dysillabic word /papà/ will be recorded, subsequently analyzed with the PRAAT software
perceptual evaluation	3 months	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.
self evaluation of voice	3 months	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.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli - IRCCS; 🇮🇹 Roma, Italy