Airway DiseaseAIRWAY-VDAPNCT06630078
Artificial Intelligence-based Voice Assessment of Children and Adults Respiratory Conditions
A study testing Wevosys acoustic analysis in people with Airway Disease and Cancer of Head and Neck, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
Trial summary
Acute and Chronic respiratory conditions represent a leading cause of death and morbidity in children and adults worldwide. The diagnosis of bronchiolitis and asthmatic exacerbations is based on clinical, and mostly subjective, clinical parameters with moderately accurate prognostic role. Read more about this study
- Who is it for?
- Ages 12 months to 70 years
- Conditions the study is for
- Airway Disease, Cancer of Head and Neck, Radiotherapy
- What is being tested?
- Wevosys acoustic analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Nov 2024to 1 Sep 2026
- 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 12 months to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children with bronchiolitis <24 months of age clinically characterized according to the clinical definition accepted by international literature (Ralstone);
- Children with asthma according to most recent GINA guidance (Global Initiative for Asthma, 2022) aged 6-12 years in a phase of proper control or during acute exacerbations;
- Adults with upper aerodigestive tract chronic or acute clinical conditions;
- Adults with pathologic diagnosis of head and neck cancer addressed to radiotherapy with or without chemotherapy for primary treatment of the tumor.
Who cannot join
- Children with comorbidities including genetic disorders;
- Children with other chronic respiratory conditions (bronchodysplasia, cystic fibrosis);
- Children with primary immunologic diseases;
- Children with prematurity;
- Children with other respiratory conditions not part of the inclusion criteria (examples: pneumonia, tonsillitis);
- Adults over 70 years old or with neurological diseases;
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- Adults with syndromic disease;
- Adults with malformations of upper aero-digestive tract;
- Adults with history of head and neck surgery or not able to sustain a vocalism for more than 3 sec.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Jacopo Galli
Roma, 00168
Jacopo Galli, +393338356370, jacopo.galli@policlinicogemelli.it
Jacopo Galli
Maria Raffaella Marchese
Roma, 00198
About this study
Official title: Artificial Intelligence-based Voice Assessment of Children and Adults With Acute and Chronic Respiratory Conditions: Diagnostic and Prognostic Role
Acute and Chronic respiratory conditions represent a leading cause of death and morbidity in children and adults worldwide. The diagnosis of bronchiolitis and asthmatic exacerbations is based on clinical, and mostly subjective, clinical parameters with moderately accurate prognostic role. Patients undergoing neck radiotherapy need invasive assessments of larynx. A simple biomarker like Voice may facilitate the management of these conditions. Recent studies showed that VOICE may be used as a good and easy biomarker to diagnose and monitor several respiratory and non-respiratory conditions. A prospective study aimed to collected VOICE and other clinical data in adults and children with common acute and chronic respiratory conditions at high impact on healthcare systems will be performed. VOICE-omic data will be linked with clinical findings generating data integration, using artificial intelligence technology to develop a Decision Support Systems to provide the basis for non-invasive personalised early recognition, diagnosis, monitoring and prognosis of patients with these conditions.
- Conditions
- Airway Disease, Cancer of Head and Neck, Radiotherapy, Bronchiolitis, Asthma
- Being tested
- Wevosys acoustic analysis
- Medical subject headings
- Head and Neck Neoplasms, Bronchiolitis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wevosys acoustic analysisDevice
Recording of voice signal of subjects enrolled
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | children with bronchiolits, controlled asthma and asthmatic re-exacerbations and adults with primary upper aero-digestive tract affections or secondary to radiotherapy Receives: Device: Wevosys acoustic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acoustic parameters of voice signal in children
Fundamental frequency (F0), measured in Hertz, is defined as the number of times a sound wave produced by the vocal cords repeats during a given time period, it is also the number of cycles of opening/closure of the glottis.
Measured: enrollment; 24 and 48 hours post-therapy; 24 months
Acoustic parameters of voice signal in children
Jitter (%) is the variation from cycle of opening/closure of the glottis to cycle.
Measured: enrollment; 24 and 48 hours post-therapy; 24 months
Acoustic parameters of voice signal in children
Shimmer (%) relates to the amplitude variation of the sound wave.
Measured: enrollment; 24 and 48 hours post-therapy; 24 months
Acoustic parameters of voice signal in children
NHR (decibel) that is an assessment of the ratio between periodic components and non periodic component comprising a segment of voiced speech.
Measured: enrollment; 24 and 48 hours post-therapy; 24 months
Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases
Fundamental frequency (F0), measured in Hertz, is defined as the number of times a sound wave produced by the vocal cords repeats during a given time period, it is also the number of cycles of opening/closure of the glottis.
Measured: enrollment; 24 and 48 hours post-therapy; 24 months
Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases
Jitter (%) is the variation from cycle of opening/closure of the glottis to cycle; Shimmer (%) relates to the amplitude variation of the sound wave.
Measured: enrollment; 24 and 48 hours post-therapy; 24 months
Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases
Shimmer (%) relates to the amplitude variation of the sound wave.
Measured: enrollment; 24 and 48 hours post-therapy; 24 months
Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases
NHR (decibel) that is an assessment of the ratio between periodic components and non periodic component comprising a segment of voiced speech.
Measured: enrollment; 24 and 48 hours post-therapy; 24 months
Pediatric Dyspnea Scale
The child is asked to answer the question "How much difficulty are you having breathing?" by choosing the column that best corresponds to his or her perceived symptoms (range from 0 not trouble at all to 7 very much trouble)
Measured: enrollment; 24 hours and 48 hours post-therapy; 24 months
Voice Handicap Index score in adults affected by acute or chronic upper aerodigestive diseases
The Voice Handicap Index is self-assessment instrument useful for quantifying the biopsychosocial impact of a voice disorder. It consists of 30 items. The total score ranges from 0 (no impact of dysphonia) to 120 (the worst possibile impact of dysphonia)
Measured: enrollment; 24 hours and 48 hours after therapy; 24 months
Acoustic parameters of voice signal in adults underwent radiotherapy
Fundamental frequency (F0), measured in Hertz, is defined as the number of times a sound wave produced by the vocal cords repeats during a given time period, it is also the number of cycles of opening/closure of the glottis.
Measured: enrollment; on the 30th day of radiotherapy
Acoustic parameters of voice signal in adults underwent radiotherapy
Jitter (%) is the variation from cycle of opening/closure of the glottis to cycle.
Measured: enrollment; on the 30th day of radiotherapy
Acoustic parameters of voice signal in adults underwent radiotherapy
Shimmer (%) relates to the amplitude variation of the sound wave.
Measured: enrollment; on the 30th day of radiotherapy
Acoustic parameters of voice signal in adults underwent radiotherapy
NHR (decibel) that is an assessment of the ratio between periodic components and non periodic component comprising a segment of voiced speech.
Measured: enrollment; on the 30th day of radiotherapy
Voice Handicap Index score in adults who underwent radiotherapy
The Voice Handicap Index is self-assessment instrument useful for quantifying the biopsychosocial impact of a voice disorder. It consists of 30 items. The total score ranges from 0 (no impact of dysphonia) to 120 (the worst possibile impact of dysphonia)
Measured: enrollment; on the 30th day of radiotherapy
Dysphagia Handicap Index in adults who underwent radiotherapy
The Dysphagia Handicap Index is a 25-item measure of Health-related Quality of Life for patients with oropharyngeal dysphagia of heterogeneous etiologies. The total score ranges from 0 to 100, with lower scores indicating better swallowing-related QoL.
Measured: enrollmentt; on the 30th day of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start30 Nov 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galli Jacopo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Jacopo Galli, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630078
- Sponsor's protocol ID
- ID6812
- Acronym
- AIRWAY-VDAP
- Status last verified
- Oct 2024
- First submitted
- 25 Jul 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-based Voice Assessment of Children and Adults With Acute and Chronic Respiratory Conditions: Diagnostic and Prognostic Role
- ClinicalTrials.gov ID
- NCT06630078
- Acronym / sponsor ID
- AIRWAY-VDAP / ID6812
- Conditions
- Airway Disease, Cancer of Head and Neck, Radiotherapy, Bronchiolitis, Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 8 Oct 2024 (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.
Acute and Chronic respiratory conditions represent a leading cause of death and morbidity in children and adults worldwide. The diagnosis of bronchiolitis and asthmatic exacerbations is based on clinical, and mostly subjective, clinical parameters with moderately accurate prognostic role. Patients undergoing neck radiotherapy need invasive assessments of larynx. A simple biomarker like Voice may facilitate the management of these conditions. Recent studies showed that VOICE may be used as a good and easy biomarker to diagnose and monitor several respiratory and non-respiratory conditions. A prospective study aimed to collected VOICE and other clinical data in adults and children with common acute and chronic respiratory conditions at high impact on healthcare systems will be performed. VOICE-omic data will be linked with clinical findings generating data integration, using artificial intelligence technology to develop a Decision Support Systems to provide the basis for non-invasive personalised early recognition, diagnosis, monitoring and prognosis of patients with these conditions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Device: Wevosys acoustic analysischildren with bronchiolits, controlled asthma and asthmatic re-exacerbations and adults with primary upper aero-digestive tract affections or secondary to radiotherapy |
Who may qualify
- Ages
- 12 months to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Children with bronchiolitis <24 months of age clinically characterized according to the clinical definition accepted by international literature (Ralstone);
- Children with asthma according to most recent GINA guidance (Global Initiative for Asthma, 2022) aged 6-12 years in a phase of proper control or during acute exacerbations;
- Adults with upper aerodigestive tract chronic or acute clinical conditions;
- Adults with pathologic diagnosis of head and neck cancer addressed to radiotherapy with or without chemotherapy for primary treatment of the tumor.
Key exclusion criteria (9 listed)
- Children with comorbidities including genetic disorders;
- Children with other chronic respiratory conditions (bronchodysplasia, cystic fibrosis);
- Children with primary immunologic diseases;
- Children with prematurity;
- Children with other respiratory conditions not part of the inclusion criteria (examples: pneumonia, tonsillitis);
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 |
|---|---|---|
| Wevosys acoustic analysisRecording of voice signal of subjects enrolled | Device | Case group |
Primary outcome
Acoustic parameters of voice signal in children
Time frame: enrollment; 24 and 48 hours post-therapy; 24 months
Fundamental frequency (F0), measured in Hertz, is defined as the number of times a sound wave produced by the vocal cords repeats during a given time period, it is also the number of cycles of opening/closure of the glottis.
Acoustic parameters of voice signal in children
Time frame: enrollment; 24 and 48 hours post-therapy; 24 months
Jitter (%) is the variation from cycle of opening/closure of the glottis to cycle.
Acoustic parameters of voice signal in children
Time frame: enrollment; 24 and 48 hours post-therapy; 24 months
Shimmer (%) relates to the amplitude variation of the sound wave.
Acoustic parameters of voice signal in children
Time frame: enrollment; 24 and 48 hours post-therapy; 24 months
NHR (decibel) that is an assessment of the ratio between periodic components and non periodic component comprising a segment of voiced speech.
Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases
Time frame: enrollment; 24 and 48 hours post-therapy; 24 months
Fundamental frequency (F0), measured in Hertz, is defined as the number of times a sound wave produced by the vocal cords repeats during a given time period, it is also the number of cycles of opening/closure of the glottis.
Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases
Time frame: enrollment; 24 and 48 hours post-therapy; 24 months
Jitter (%) is the variation from cycle of opening/closure of the glottis to cycle; Shimmer (%) relates to the amplitude variation of the sound wave.
Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases
Time frame: enrollment; 24 and 48 hours post-therapy; 24 months
Shimmer (%) relates to the amplitude variation of the sound wave.
Acoustic parameters of voice signal in adults affected by acute or chronic upper aerodigestive diseases
Time frame: enrollment; 24 and 48 hours post-therapy; 24 months
NHR (decibel) that is an assessment of the ratio between periodic components and non periodic component comprising a segment of voiced speech.
Pediatric Dyspnea Scale
Time frame: enrollment; 24 hours and 48 hours post-therapy; 24 months
The child is asked to answer the question "How much difficulty are you having breathing?" by choosing the column that best corresponds to his or her perceived symptoms (range from 0 not trouble at all to 7 very much trouble)
Voice Handicap Index score in adults affected by acute or chronic upper aerodigestive diseases
Time frame: enrollment; 24 hours and 48 hours after therapy; 24 months
The Voice Handicap Index is self-assessment instrument useful for quantifying the biopsychosocial impact of a voice disorder. It consists of 30 items. The total score ranges from 0 (no impact of dysphonia) to 120 (the worst possibile impact of dysphonia)
Acoustic parameters of voice signal in adults underwent radiotherapy
Time frame: enrollment; on the 30th day of radiotherapy
Fundamental frequency (F0), measured in Hertz, is defined as the number of times a sound wave produced by the vocal cords repeats during a given time period, it is also the number of cycles of opening/closure of the glottis.
Acoustic parameters of voice signal in adults underwent radiotherapy
Time frame: enrollment; on the 30th day of radiotherapy
Jitter (%) is the variation from cycle of opening/closure of the glottis to cycle.
Acoustic parameters of voice signal in adults underwent radiotherapy
Time frame: enrollment; on the 30th day of radiotherapy
Shimmer (%) relates to the amplitude variation of the sound wave.
Acoustic parameters of voice signal in adults underwent radiotherapy
Time frame: enrollment; on the 30th day of radiotherapy
NHR (decibel) that is an assessment of the ratio between periodic components and non periodic component comprising a segment of voiced speech.
Voice Handicap Index score in adults who underwent radiotherapy
Time frame: enrollment; on the 30th day of radiotherapy
The Voice Handicap Index is self-assessment instrument useful for quantifying the biopsychosocial impact of a voice disorder. It consists of 30 items. The total score ranges from 0 (no impact of dysphonia) to 120 (the worst possibile impact of dysphonia)
Dysphagia Handicap Index in adults who underwent radiotherapy
Time frame: enrollmentt; on the 30th day of radiotherapy
The Dysphagia Handicap Index is a 25-item measure of Health-related Quality of Life for patients with oropharyngeal dysphagia of heterogeneous etiologies. The total score ranges from 0 to 100, with lower scores indicating better swallowing-related QoL.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Jacopo Galli principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wevosys acoustic analysis in people with Airway Disease and Cancer of Head and Neck, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites 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 9 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 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Jacopo Galli (+393338356370, jacopo.galli@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acoustic parameters of voice signal in children (time frame: enrollment; 24 and 48 hours post-therapy; 24 months). The study lists 16 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 18 Oct 2024.