Voice DisordersNCT03076931
Development of Imaging Biomarkers for Voice After Pediatric Airway Reconstruction
A study testing Microlaryngoscopy, Voice Evaluation and Airway Reconstruction in people with Voice Disorders, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Objective: The purpose of this proposal is to use High Speed Videoendoscopy (HSV) to develop and test an imaging biomarker to support diagnosis and predict vibratory outcome after airway reconstruction. Read more about this study
- Who is it for?
- Ages 3 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Voice Disorders
- What is being tested?
- Microlaryngoscopy, Voice Evaluation and Airway Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 15 Oct 2019
- 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 3 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages of 3-30 years,
- No prior airway surgery
- Able to undergo the evaluation protocol
- Age of 3-30 years
- No prior history of intubation injury or airway/laryngeal surgery
- Normal hearing
- Normal voice assessment performed by a certified speech-language pathologist 5.) Undergoing a non-airway surgical procedure such as adenoidectomy, tonsillectomy, ear tubes, and neck mass removal.
Who cannot join
- 1.) Patients who have undergone any prior airway reconstruction and/or have a disability that precludes them from completing the evaluation
- Control Patients
- Has had airway or laryngeal surgery
- History of a voice or hearing disorder
- History of neonatal intubation over 14 days
- Have a disability that precludes them from completing the evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Objective:
The purpose of this proposal is to use High Speed Videoendoscopy (HSV) to develop and test an imaging biomarker to support diagnosis and predict vibratory outcome after airway reconstruction. Our protocol will involve eliciting and recording the following five behaviors: (1) hard throat clear; (2) cough; (3) laugh; (4) short multiple phonations; and (5) sustained phonation. These HSV recordings will be used to develop the biomarkers.
Read more
Study Design: A prospective cohort study of 60 patients, 36 who will undergo airway reconstruction and 24 age matched controls.
Setting: Center for Pediatric Voice Disorders, Department of Otolaryngology, Cincinnati Children's Hospital Medical Center
Methods: Subjects will undergo a full voice evaluation, including an HSV evaluation protocol, at the main study site prior to airway reconstruction, 6 months post and 1 year post surgery. Voice evaluation will include aerodynamic, acoustic, and perceptual voice assessments, a pediatric voice handicap index questionnaire, videostroboscopy, and HSV. The airway evaluation will include airway sizing and calibration.
Read the detailed description
Fifty percent of the children who undergo airway reconstruction for subglottic stenosis (narrowing of the airway below the vocal folds) develop a voice disorder. Voice disorders lead to psychosocial problems that affect many of these children over their lifetime, specifically their career choices and their long-term quality of life. Our current understanding of voice problems following surgical airway reconstruction is limited. There is a lack of research to understand the alterations of the phonatory mechanisms due to the underlying initial condition (stenosis) and the surgical airway reconstruction performed. The purpose of this proposal is to develop and test imaging biomarkers to support diagnosis and surgical decision-making leading to improved voice outcome. The overarching goal of this work is to establish a foundation upon which surgical practice could be enhanced to improve voice outcome while still achieving optimal airway results. Specifically, the project will use: a prospective pre- and post-surgery cohort design to develop an imaging biomarker of "vibratory potential" for predicting the vibratory outcome after airway reconstruction. Quantitative image processing methodology will be used for the development and validation of the new imaging biomarkers, based on high-speed videoendoscopy. This research project will address a substantial gap of knowledge in pediatric voice and airway surgery, and has the potential to significantly improve the quality of life of these patients who have some of the most severe and difficult to manage voice disorders. The results could be translated to adult patient populations and other voice disorders (e.g. development of disease-specific imaging biomarkers).
- Conditions
- Voice Disorders
- Being tested
- Microlaryngoscopy, Voice Evaluation, Airway Reconstruction
- Keywords
- Voice, Biomarker, Airway Reconstruction
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrolaryngoscopyProcedure or surgery
Also called MLB
Standard clinical procedure, used to perform airway sizing and vocal fold calibration. Controls receive one as a research procedure, while study patients receive one as part of standard of care.
Voice EvaluationProcedure or surgery
Standard clinical procedure that includes aerodynamic, acoustic, and perceptual voice assessments, a pediatric voice handicap index questionnaire, videostroboscopy, and high-speed videoendoscopy. Controls will receive one as a research procedure, while study patients will receive three, one before their airway reconstruction, and two more in the year afterward, as part of standard of care.
Airway ReconstructionProcedure or surgery
This includes many types of invasive surgical procedures such as Laryngotracheoplasty to repair a patient's compromised airway. Only study patients will be receiving one, and it will be as part of standard of care unrelated to this study, but the data from surgery and outcomes being pertinent to the study.
| Study group | Role | What they receive |
|---|---|---|
| Study: Airway Reconstruction Patients | Experimental | These participants have significant airway abnormalities that require invasive surgery, such as Laryngotracheoplasty, to rectify, and whose voice quality may suffer as a result of the surgery. The goal of this study is to improve voice outcomes of these patients, and their clinical data will be collected. Receives: Procedure: Microlaryngoscopy; Procedure: Voice Evaluation; Procedure: Airway Reconstruction |
| Control: Normal Airway Patients | Experimental | These participants have normal airways and voice who will undergo a microlaryngoscopy and voice evaluation, the data from which will be compared to study patients. Receives: Procedure: Microlaryngoscopy; Procedure: Voice Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Patient's Vibratory Source
Vibratory source will be rated by having HSV imaging samples subjected to an automatic temporal segmentation, which will extract the HSV segment of interest. The extracted temporal segment (i.e. token) is subjected to an automatic image segmentation based on the oscillating edges of the anatomic structures using kymographic paired active contours. The image segmentation will be aided by an automatic spectral oscillation analysis similar to previously published methods. Three raters will be asked to interpret the image analysis results, which will be overlaid on the HSV image. To identify the patient's vibratory source, among the segmented vibratory areas, the raters will identify which vibratory structure(s)--glottis, false vocal folds, aryepiglottic folds, arytenoid against epiglottis, other supraglottal structures, or any combination of those--could be phonatory/which anatomic structure produced the vibration.
Measured: Up to One Year
Secondary outcomes (6)
Tissue Health of Patient--Vocal Fold Vibration
Tissue health will be rated using a specialized Matlab graphic user interface (GUI). The rating protocol for preoperative and postoperative measurement will assess vibratory features on an ordinal scale, as follows: Vocal-fold vibration will be rated as: vibration with contact; vibration, no contact; no vibration, with contact; no vibration, no contact; can't identify vocal folds; or can't rate. The raters will then be asked to grade their overall rating confidence in their rating. Confidence will be graded on a 5-point scale as follows: 5-highly confident; 4-confident; 3-mostly confident; 2-somewhat confident; and 1- not confident or unable to rate.
Measured: Up to One Year
Tissue Health of Patient--Scarring of Airway
Tissue health will be rated using a specialized Matlab graphic user interface (GUI). The rating protocol for preoperative and postoperative measurement will assess vibratory features on an ordinal scale, as follows:Scarring will be rated as: no scar; mild-left; mild-right; mild-bilateral; moderate-left; moderate- right; moderate- bilateral; severe-left; severe-right; severe- bilateral; or can't rate. For the visual rating of scarring, we will use the following definitions: mild scarring - present scar that has no effect or mildly reduces the mucosal wave; moderate scarring - reduced mucosal wave; severe scarring - mucosal wave not present. The raters will then be asked to grade their overall rating confidence in their rating. Confidence will be graded on a 5-point scale as follows: 5-highly confident; 4-confident; 3-mostly confident; 2-somewhat confident; and 1- not confident or unable to rate.
Measured: Up to One Year
Maximum Adduction
The computation of the adduction and abduction will be based on automatic image segmentation using temporally-paired active contours followed by extraction of a glottal area width (GAW) signal. This measure will be calibrated to the units of mm based on the segmented airway size relative to the size of the calibration surgical instrument recorded on the intraoperative image. Maximum adduction will be computed from the GAW signal.
Measured: Up to One Year
Maximum Abduction
The computation of the adduction and abduction will be based on automatic image segmentation using temporally-paired active contours followed by extraction of a glottal area width (GAW) signal. This measure will be calibrated to the units of mm based on the segmented airway size relative to the size of the calibration surgical instrument recorded on the intraoperative image. Maximum abduction will be computed from the GAW signal.
Measured: Up to One Year
Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Three certified speech-language pathologists with extensive experience in the assessment and treatment of pediatric voice disorders will perform all CAPE-V ratings. Each sample will contain the six CAPE-V sentences or modified sentences based on the ability of the child.
Rating sheets will list only the participant's study number, age, and gender. Judges will independently listen to the samples (a maximum of three times per sample) in a quiet environment using headphones (the headphones will not have a separate volume control function. Averages of the three judges will be performed to obtain the Overall Severity rating. Twenty-five percent of the voice samples will be randomly selected to estimate intra-rater reliability. Inter-rater reliability will also be evaluated. If CAPE-V Overall Severity ratings differ greater than 20%, samples will be set aside and evaluated in a consensus of all three judges. This consensus will establish the final Overall Severity rating.
Measured: Up to One Year
Pediatric Voice Handicap Index
Questionnaire designed to assess the impact on quality of life that the patient's voice problems pose. This is administered during each voice evaluation to track changes. Voice handicapping/voice-related quality of life will be evaluated using the Pediatric Voice Handicap Index (pVHI). The pVHI is a handicapping index that was modified from the original Adult Voice Handicap Index into a parental proxy form.
The pVHI is a self-rating of voice handicapping based on a summed score (0-92). This system has three domains: 1) functional, 2) physical, and 3) emotional.
Measured: Up to One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start1 Aug 2016
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
Why it stopped: 0 subjects completed all study visits. Due to noncompliance and recruitment difficulties study was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice DisordersStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Triological Society
- Responsible party
- Sponsor
- Investigators
- Alessandro de Alarcon, MD, Principal investigator, CCHMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076931
- Sponsor's protocol ID
- 2016-2378
- Status last verified
- Feb 2021
- First submitted
- 15 Dec 2016
- Last updated
- 9 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Imaging Biomarkers for Voice After Pediatric Airway Reconstruction
- ClinicalTrials.gov ID
- NCT03076931
- Acronym / sponsor ID
- 2016-2378
- Conditions
- Voice Disorders
- Keywords
- Voice, Biomarker, Airway Reconstruction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 0 subjects completed all study visits. Due to noncompliance and recruitment difficulties study was terminated.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Triological Society
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 10 Mar 2017 (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.
Objective:
The purpose of this proposal is to use High Speed Videoendoscopy (HSV) to develop and test an imaging biomarker to support diagnosis and predict vibratory outcome after airway reconstruction. Our protocol will involve eliciting and recording the following five behaviors: (1) hard throat clear; (2) cough; (3) laugh; (4) short multiple phonations; and (5) sustained phonation. These HSV recordings will be used to develop the biomarkers.
Study Design: A prospective cohort study of 60 patients, 36 who will undergo airway reconstruction and 24 age matched controls.
Setting: Center for Pediatric Voice Disorders, Department of Otolaryngology, Cincinnati Children's Hospital Medical Center
Methods: Subjects will undergo a full voice evaluation, including an HSV evaluation protocol, at the main study site prior to airway reconstruction, 6 months post and 1 year post surgery. Voice evaluation will include aerodynamic, acoustic, and perceptual voice assessments, a pediatric voice handicap index questionnaire, videostroboscopy, and HSV. The airway evaluation will include airway sizing and calibration.
Detailed description
Fifty percent of the children who undergo airway reconstruction for subglottic stenosis (narrowing of the airway below the vocal folds) develop a voice disorder. Voice disorders lead to psychosocial problems that affect many of these children over their lifetime, specifically their career choices and their long-term quality of life. Our current understanding of voice problems following surgical airway reconstruction is limited. There is a lack of research to understand the alterations of the phonatory mechanisms due to the underlying initial condition (stenosis) and the surgical airway reconstruction performed. The purpose of this proposal is to develop and test imaging biomarkers to support diagnosis and surgical decision-making leading to improved voice outcome. The overarching goal of this work is to establish a foundation upon which surgical practice could be enhanced to improve voice outcome while still achieving optimal airway results. Specifically, the project will use: a prospective pre- and post-surgery cohort design to develop an imaging biomarker of "vibratory potential" for predicting the vibratory outcome after airway reconstruction. Quantitative image processing methodology will be used for the development and validation of the new imaging biomarkers, based on high-speed videoendoscopy. This research project will address a substantial gap of knowledge in pediatric voice and airway surgery, and has the potential to significantly improve the quality of life of these patients who have some of the most severe and difficult to manage voice disorders. The results could be translated to adult patient populations and other voice disorders (e.g. development of disease-specific imaging biomarkers).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study: Airway Reconstruction Patients | Experimental | Procedure: Microlaryngoscopy, Procedure: Voice Evaluation, Procedure: Airway ReconstructionThese participants have significant airway abnormalities that require invasive surgery, such as Laryngotracheoplasty, to rectify, and whose voice quality may suffer as a result of the surgery. The goal of this study is to improve voice outcomes of these patients, and their clinical data will be collected. |
| Control: Normal Airway Patients | Experimental | Procedure: Microlaryngoscopy, Procedure: Voice EvaluationThese participants have normal airways and voice who will undergo a microlaryngoscopy and voice evaluation, the data from which will be compared to study patients. |
Who may qualify
- Ages
- 3 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Ages of 3-30 years,
- No prior airway surgery
- Able to undergo the evaluation protocol
- Age of 3-30 years
- No prior history of intubation injury or airway/laryngeal surgery
Key exclusion criteria (6 listed)
- 1.) Patients who have undergone any prior airway reconstruction and/or have a disability that precludes them from completing the evaluation
- Control Patients
- Has had airway or laryngeal surgery
- History of a voice or hearing disorder
- History of neonatal intubation over 14 days
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 |
|---|---|---|
| MicrolaryngoscopyAlso: MLBStandard clinical procedure, used to perform airway sizing and vocal fold calibration. Controls receive one as a research procedure, while study patients receive one as part of standard of care. | Procedure or surgery | Control: Normal Airway Patients, Study: Airway Reconstruction Patients |
| Voice EvaluationStandard clinical procedure that includes aerodynamic, acoustic, and perceptual voice assessments, a pediatric voice handicap index questionnaire, videostroboscopy, and high-speed videoendoscopy. Controls will receive one as a research procedure, while study patients will receive three, one before their airway reconstruction, and two more in the year afterward, as part of standard of care. | Procedure or surgery | Control: Normal Airway Patients, Study: Airway Reconstruction Patients |
| Airway ReconstructionThis includes many types of invasive surgical procedures such as Laryngotracheoplasty to repair a patient's compromised airway. Only study patients will be receiving one, and it will be as part of standard of care unrelated to this study, but the data from surgery and outcomes being pertinent to the study. | Procedure or surgery | Study: Airway Reconstruction Patients |
Primary outcome
Identification of Patient's Vibratory Source
Time frame: Up to One Year
Vibratory source will be rated by having HSV imaging samples subjected to an automatic temporal segmentation, which will extract the HSV segment of interest. The extracted temporal segment (i.e. token) is subjected to an automatic image segmentation based on the oscillating edges of the anatomic structures using kymographic paired active contours. The image segmentation will be aided by an automatic spectral oscillation analysis similar to previously published methods. Three raters will be asked to interpret the image analysis results, which will be overlaid on the HSV image. To identify the patient's vibratory source, among the segmented vibratory areas, the raters will identify which vibratory structure(s)--glottis, false vocal folds, aryepiglottic folds, arytenoid against epiglottis, other supraglottal structures, or any combination of those--could be phonatory/which anatomic structure produced the vibration.
6 secondary outcomes
Tissue Health of Patient--Vocal Fold Vibration
Time frame: Up to One Year
Tissue Health of Patient--Scarring of Airway
Time frame: Up to One Year
Maximum Adduction
Time frame: Up to One Year
Maximum Abduction
Time frame: Up to One Year
Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Time frame: Up to One Year
Pediatric Voice Handicap Index
Time frame: Up to One Year
Results and safety
The study was stopped early (reason given: 0 subjects completed all study visits. Due to noncompliance and recruitment difficulties study was terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
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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.
Alessandro de Alarcon, MD principal investigator
CCHMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microlaryngoscopy, Voice Evaluation and Airway Reconstruction in people with Voice Disorders, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 9 Feb 2021. 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 United States. 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?
The study was stopped early (reason given: 0 subjects completed all study visits. Due to noncompliance and recruitment difficulties study was terminated.). 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?
Identification of Patient's Vibratory Source (time frame: Up to One Year). 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 9 Feb 2021.