Bruni® Training in OPHL Patients (BTLS)
September 22, 2023 updated by: LONGOBARDI YLENIA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Roma, Italy, 00168
- Fondazione Policlinico Universitario A. Gemelli - IRCCS
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: OPHL patients
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum phonation time
Time Frame: 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
|
3 months
|
|
type of spectrogram
Time Frame: 3 months
|
A sustained /a/ will be recorded, subsequently analyzed with the PRAAT software.
|
3 months
|
|
foundamental frequency
Time Frame: 3 months
|
A sustained /a/ will be recorded, subsequently analyzed with the PRAAT software
|
3 months
|
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Formantic peaks
Time Frame: 3 months
|
The dysillabic word /papà/ will be recorded, subsequently analyzed with the PRAAT software
|
3 months
|
|
perceptual evaluation
Time Frame: 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.
|
3 months
|
|
self evaluation of voice
Time Frame: 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.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2023
Primary Completion (Estimated)
January 1, 2024
Study Completion (Estimated)
April 30, 2024
Study Registration Dates
First Submitted
September 22, 2023
First Submitted That Met QC Criteria
September 22, 2023
First Posted (Actual)
September 28, 2023
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 22, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 5631 (Other Identifier: Signe and Ane Gyllenbergs foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.