NOT_YET_RECRUITING
Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort
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.
Conditions:
🦠 Presbylarynx 🦠 Aspiration 🦠 Spasmodic Dysphonia 🦠 Globus Pharyngeus 🦠 Larynx Paralysis 🦠 Laryngeal Disease 🦠 Vocal Cord Paralysis 🦠 Iatrogenic Injury 🦠 Sensory Neuropathy
🗓️ Study Start (Actual) 1 August 2024
🗓️ Primary Completion (Estimated) 31 March 2026
✅ Study Completion (Estimated) 31 March 2026
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 San Francisco, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Age \<=18 years.
    • 2. 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
    • 3. Ability and willingness to comply with study procedures.
    • 4. Ability to understand a written informed consent document, and the willingness to sign it.

    Exclusion Criteria:

    • 1. Non-English speaking.
    • 2. Laryngopharyngeal structures are not accessible on exam.
    • 3. Known contraindication to any study-related procedure, or history of being unable to tolerate laryngoscopy.
    • 4. Vocal fold immobility or severe hypomobility on adduction.
    • 5. 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).
Ages Eligible for Study: 18 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 5 October 2023
  • First Submitted that Met QC Criteria 5 October 2023
  • First Posted 12 October 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 June 2024
  • Last Update Posted 21 June 2024
  • Last Verified June 2024