Substitution VoiceBTLSNCT06058273
Bruni® Training in OPHL Patients
A study testing Bruni® training in people with Substitution Voice, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substitution Voice
- What is being tested?
- Bruni® training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18;
- Italian mother tongue;
- ability to produce the replacement voice;
- ability to provide written informed consent
Who cannot join
- < 1 year from the end of both surgical and radiotherapy treatment;
- presence of disease recurrence;
- sensory, neurological deficits
- Learning disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Substitution Voice
- Being tested
- Bruni® training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bruni® trainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| OPHL patients | Experimental | Not described Receives: Behavioral: Bruni® training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
type of spectrogram
A sustained /a/ will be recorded, subsequently analyzed with the PRAAT software.
Measured: 3 months
foundamental frequency
A sustained /a/ will be recorded, subsequently analyzed with the PRAAT software
Measured: 3 months
Formantic peaks
The dysillabic word /papà/ will be recorded, subsequently analyzed with the PRAAT software
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substitution VoiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LONGOBARDI YLENIA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058273
- Sponsor's protocol ID
- 5631
- Acronym
- BTLS
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06058273
- Acronym / sponsor ID
- BTLS / 5631
- Conditions
- Substitution Voice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPHL patients | Experimental | Behavioral: Bruni® training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18;
- Italian mother tongue;
- ability to produce the replacement voice;
- ability to provide written informed consent
Key exclusion criteria (4 listed)
- < 1 year from the end of both surgical and radiotherapy treatment;
- presence of disease recurrence;
- sensory, neurological deficits
- Learning disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bruni® training10 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 | Behavioural | OPHL patients |
Primary outcome
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
type of spectrogram
Time frame: 3 months
A sustained /a/ will be recorded, subsequently analyzed with the PRAAT software.
foundamental frequency
Time frame: 3 months
A sustained /a/ will be recorded, subsequently analyzed with the PRAAT software
Formantic peaks
Time frame: 3 months
The dysillabic word /papà/ will be recorded, subsequently analyzed with the PRAAT software
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bruni® training in people with Substitution Voice, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum phonation time (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.