PresbylarynxNCT06078527
Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort
An observational study of Presbylarynx and Aspiration, run by University of California, San Francisco at 1 site in United States.
Trial summary
A previous study completed in 2022 (NCT05158179) was conducted using cohorts of healthy controls, and adults with general laryngopharyngeal disorders. This study will expand on the previous research to include a separate cohort of adults being seen in clinic for an existing laryngopharyngeal disorder resulting from… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Presbylarynx, Aspiration, Spasmodic Dysphonia
- What is being tested?
- Cheung-Bearelly Aesthesiometer, Transnasal Laryngoscopy and Questionnaires
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 505 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2027to 30 Jun 2028
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients recruited from the UCSF Voice and Swallowing Center and other clinics within the UCSF Department of Otolaryngology-Head and Neck Surgery. Healthy control participants will be recruited from UCSF Health and the broader UCSF community.
Who may be able to join
- Age <=18 years.
- Individuals without a laryngopharyngeal disorder (health controls) or with a laryngopharyngeal disorder. Laryngopharyngeal disorder includes but is not limited to: presbylarynx, aspiration; spasmodic dysphonia; globus pharynges; vocal fold paralysis; iatrogenic injury to the larynx; muscle tension dysphonia; neurogenic dysphagia; laryngeal sensory neuropathy; and laryngopharyngeal disorders resulting from prior radiation therapy in individuals with a history of head and neck cancer who have completed radiation therapy as primary or adjuvant cancer treatment
- Ability and willingness to comply with study procedures.
- Ability to understand a written informed consent document, and the willingness to sign it.
Who cannot join
- Non-English speaking.
- Laryngopharyngeal structures are not accessible on exam.
- Known contraindication to any study-related procedure, or history of being unable to tolerate laryngoscopy.
- Vocal fold immobility or severe hypomobility on adduction.
- For head and neck cancer survivors only: Currently undergoing radiation therapy for head and neck cancer (i.e., primary/adjuvant radiation therapy treatment plan is not yet completed).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Assessment of Laryngopharyngeal Sensation in Patients With Laryngopharyngeal Disorders
A previous study completed in 2022 (NCT05158179) was conducted using cohorts of healthy controls, and adults with general laryngopharyngeal disorders. This study will expand on the previous research to include a separate cohort of adults being seen in clinic for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments.
Read the detailed description
PRIMARY OBJECTIVES:
- Laryngeal sensation as measured by elicitation of laryngeal adductor reflex (LAR).
II. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to the Penetration-Aspiration Scale (PAS).
SECONDARY OBJECTIVES:
- To assess patient-reported laryngeal sensation (PRLS) following stimulus and perceptual strength.
II. To assess laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus.
III. To assess patient reported outcomes (PROs).
EXPLORATORY OBJECTIVES:
- To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to:
- modified barium swallow (MBS) study kinematics;
- MBS Dynamic Imaging Grade of Swallowing Toxicity (MBS DIGEST);
- MD Anderson Dysphagia Inventory patient reported outcomes measure (MDADI PROMs);
- Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing (DIGEST-FEES)
- Flexible Endoscopic Evaluation of Swallowing Visual Analysis of Swallowing Efficiency and Safety (FEES VASES).
OUTLINE:
Participants receiving care at University of California, San Francisco (UCSF) for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments will undergo laryngopharyngeal sensory testing at a single visit. There will be up to 2 years of medical record follow up after completing the main study. Data collected from this separate cohort may be compared with historical data collected in a previous study (NCT05158179).
- Conditions
- Presbylarynx, Aspiration, Spasmodic Dysphonia, Globus Pharyngeus, Larynx Paralysis, Laryngeal Disease
- Being tested
- Cheung-Bearelly Aesthesiometer, Transnasal Laryngoscopy, Questionnaires
- Keywords
- Cancer survivors, Previous cancer treatment, Laryngopharyngeal disorders
- Medical subject headings
- Dysphonia, Globus Sensation, Vocal Cord Paralysis, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cheung-Bearelly AesthesiometerDevice
Also called Aesthesiometer
The Cheung-Bearelly Aesthesiometer will be used to deliver a range of calibrated stimuli through the channeled flexible laryngoscope to assess sensation of the laryngopharynx.
Transnasal LaryngoscopyProcedure or surgery
Also called Transnasal Flexible Laryngoscopy
A procedure to examine your larynx (voice box)
QuestionnairesOther
Patient-reported health and behavioral outcomes measures will be administered
| Study group | Role | What they receive |
|---|---|---|
| Cancer Survivors | Participants will attend a single 15-30 minute study session during which they will answer questionnaires (5-10 minutes) and undergo laryngopharyngeal sensory testing (10-20 minutes). There will be up to 2 years of medical record follow up after completing the main study. Receives: Device: Cheung-Bearelly Aesthesiometer; Procedure: Transnasal Laryngoscopy; Other: Questionnaires | |
| Healthy Controls | Participants will attend a single 15-30 minute study session during which they will answer questionnaires (5-10 minutes) and undergo laryngopharyngeal sensory testing (10-20 minutes). There will be up to 2 years of medical record follow up after completing the main study. Receives: Device: Cheung-Bearelly Aesthesiometer; Procedure: Transnasal Laryngoscopy; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with triggered/positive laryngeal adduction response (LAR)
Elicitation of LAR is defined as a unilateral or bilateral laryngeal adduction immediately following laryngeal stimulus through frame-by-frame analysis of video recordings (visualized on laryngoscopy). An acceptable tactile stimulus is near orthogonal (less than 30 degrees deviation) to the mucosal surface and unobstructed by salivary forces. The percentage of participants with LAR will be reported
Measured: 1 day
Median scores on the Penetration-Aspiration Scale (PAS)
The PAS is a widely-used ordinal scale metric used to describe severity of aspiration. The PAS score is multidimensional, i.e., include several observations within each score: (1) depth of airway invasion (material above, contacting, or below the level of vocal folds; (2) whether or not there is material remaining after the swallow (ejected, not ejected); and (3) the patient's response to material present in the airway (effort to clear the material). The PAS is an 8-point ordinal scale, with a total score ranging from 1 representing the least and 8 representing the highest or most severe score.
Measured: 1 day
Secondary outcomes (2)
Median scores on the participant-reported laryngeal sensation (PRLS)
The PRLS is defined as a binary response to participants' self-reported detection of laryngeal stimulation. Once the participant indicates they perceived the stimulus, the research team will ask the participant to provide a perceptual strength rating on a 1-10 scale, with higher scores indicated a greater strength of stimulus.
Measured: 1 day
Percentage of participants with visualized laryngopharyngeal responses
Percentage of participants with visualized laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus will be recorded by the clinician and reported.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start30 Jun 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Why it stopped: Operational
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbylarynxStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 505 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Spasmodic Dysphonia Association
- Responsible party
- Sponsor
- Investigators
- Yue Ma, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078527
- Sponsor's protocol ID
- 232011
- Other IDs
- NCI-2023-10667
- Status last verified
- Nov 2026
- First submitted
- 5 Oct 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Laryngopharyngeal Sensation in Patients With Laryngopharyngeal Disorders
- ClinicalTrials.gov ID
- NCT06078527
- Acronym / sponsor ID
- 232011
- Conditions
- Presbylarynx, Aspiration, Spasmodic Dysphonia, Globus Pharyngeus, Larynx Paralysis, Laryngeal Disease
- Keywords
- Cancer survivors, Previous cancer treatment, Laryngopharyngeal disorders
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Operational
- Enrolment
- 505 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Spasmodic Dysphonia Association
- Study start
- 30 Jun 2027 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 12 Oct 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.
A previous study completed in 2022 (NCT05158179) was conducted using cohorts of healthy controls, and adults with general laryngopharyngeal disorders. This study will expand on the previous research to include a separate cohort of adults being seen in clinic for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments.
Detailed description
PRIMARY OBJECTIVES:
- Laryngeal sensation as measured by elicitation of laryngeal adductor reflex (LAR).
II. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to the Penetration-Aspiration Scale (PAS).
SECONDARY OBJECTIVES:
- To assess patient-reported laryngeal sensation (PRLS) following stimulus and perceptual strength.
II. To assess laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus.
III. To assess patient reported outcomes (PROs).
EXPLORATORY OBJECTIVES:
- To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to:
- modified barium swallow (MBS) study kinematics;
- MBS Dynamic Imaging Grade of Swallowing Toxicity (MBS DIGEST);
- MD Anderson Dysphagia Inventory patient reported outcomes measure (MDADI PROMs);
- Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing (DIGEST-FEES)
- Flexible Endoscopic Evaluation of Swallowing Visual Analysis of Swallowing Efficiency and Safety (FEES VASES).
OUTLINE:
Participants receiving care at University of California, San Francisco (UCSF) for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments will undergo laryngopharyngeal sensory testing at a single visit. There will be up to 2 years of medical record follow up after completing the main study. Data collected from this separate cohort may be compared with historical data collected in a previous study (NCT05158179).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer Survivors | – | Device: Cheung-Bearelly Aesthesiometer, Procedure: Transnasal Laryngoscopy, Other: QuestionnairesParticipants will attend a single 15-30 minute study session during which they will answer questionnaires (5-10 minutes) and undergo laryngopharyngeal sensory testing (10-20 minutes). There will be up to 2 years of medical record follow up after completing the main study. |
| Healthy Controls | – | Device: Cheung-Bearelly Aesthesiometer, Procedure: Transnasal Laryngoscopy, Other: QuestionnairesParticipants will attend a single 15-30 minute study session during which they will answer questionnaires (5-10 minutes) and undergo laryngopharyngeal sensory testing (10-20 minutes). There will be up to 2 years of medical record follow up after completing the main study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients recruited from the UCSF Voice and Swallowing Center and other clinics within the UCSF Department of Otolaryngology-Head and Neck Surgery. Healthy control participants will be recruited from UCSF Health and the broader UCSF community.
Key inclusion criteria (4 listed)
- Age <=18 years.
- Individuals without a laryngopharyngeal disorder (health controls) or with a laryngopharyngeal disorder. Laryngopharyngeal disorder includes but is not limited to: presbylarynx, aspiration; spasmodic dysphonia; globus pharynges; vocal fold paralysis; iatrogenic injury to the larynx; muscle tension dysphonia; neurogenic dysphagia; laryngeal sensory neuropathy; and laryngopharyngeal disorders resulting from prior radiation therapy in individuals with a history of head and neck cancer who have completed radiation therapy as primary or adjuvant cancer treatment
- Ability and willingness to comply with study procedures.
- Ability to understand a written informed consent document, and the willingness to sign it.
Key exclusion criteria (5 listed)
- Non-English speaking.
- Laryngopharyngeal structures are not accessible on exam.
- Known contraindication to any study-related procedure, or history of being unable to tolerate laryngoscopy.
- Vocal fold immobility or severe hypomobility on adduction.
- For head and neck cancer survivors only: Currently undergoing radiation therapy for head and neck cancer (i.e., primary/adjuvant radiation therapy treatment plan is not yet completed).
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 |
|---|---|---|
| Cheung-Bearelly AesthesiometerAlso: AesthesiometerThe Cheung-Bearelly Aesthesiometer will be used to deliver a range of calibrated stimuli through the channeled flexible laryngoscope to assess sensation of the laryngopharynx. | Device | Cancer Survivors, Healthy Controls |
| Transnasal LaryngoscopyAlso: Transnasal Flexible LaryngoscopyA procedure to examine your larynx (voice box) | Procedure or surgery | Cancer Survivors, Healthy Controls |
| QuestionnairesPatient-reported health and behavioral outcomes measures will be administered | Other | Cancer Survivors, Healthy Controls |
Primary outcome
Percentage of participants with triggered/positive laryngeal adduction response (LAR)
Time frame: 1 day
Elicitation of LAR is defined as a unilateral or bilateral laryngeal adduction immediately following laryngeal stimulus through frame-by-frame analysis of video recordings (visualized on laryngoscopy). An acceptable tactile stimulus is near orthogonal (less than 30 degrees deviation) to the mucosal surface and unobstructed by salivary forces. The percentage of participants with LAR will be reported
Median scores on the Penetration-Aspiration Scale (PAS)
Time frame: 1 day
The PAS is a widely-used ordinal scale metric used to describe severity of aspiration. The PAS score is multidimensional, i.e., include several observations within each score: (1) depth of airway invasion (material above, contacting, or below the level of vocal folds; (2) whether or not there is material remaining after the swallow (ejected, not ejected); and (3) the patient's response to material present in the airway (effort to clear the material). The PAS is an 8-point ordinal scale, with a total score ranging from 1 representing the least and 8 representing the highest or most severe score.
2 secondary outcomes
Median scores on the participant-reported laryngeal sensation (PRLS)
Time frame: 1 day
Percentage of participants with visualized laryngopharyngeal responses
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Presbylarynx
Active, not recruiting
Improving Voice Production for Adults With Age-related Dysphonia
Presbylarynx, Age-Related Dysphonia
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.
Yue Ma, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Presbylarynx and Aspiration, run by University of California, San Francisco 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 4 inclusion and 5 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: paused, as of the sponsor's last update on 5 Nov 2026. 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?
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?
Percentage of participants with triggered/positive laryngeal adduction response (LAR) (time frame: 1 day). The study lists 2 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 5 Nov 2026.