Recruiting

Speech-Language Protocol

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06762444

Conditions

Globus Pharyngeus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Speech-language pathologist (SLP) protocol

Study Details

Brief summary:

To develop a standardized speech-language pathology treatment protocol to systematically address Globus pharyngeus (GP) as a proof of concept

Conditions

Globus Pharyngeus

Study ID

NCT06762444

Start date

Aug 28, 2025

Status verified date

Dec, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Volunteer adult patients (age 18 and over) evaluated at the Atrium Health Wake Forest Baptist Center for Voice and Swallowing Disorders who report a complaint of globus pharyngeus

Exclusion Criteria:

  • Patients diagnosed with a swallowing disorder will be excluded from the study

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: The SLP intervention protocol

The SLP intervention protocol consists of six components, all of which will be implemented by the treating speech-language pathologist

Interventions

Speech-language pathologist (SLP) protocol

The SLP intervention protocol consists of six components, all of which will be implemented by the treating speech-language pathologist

Primary outcome measure

  • Laryngopharyngeal Measure of Perceived Sensation (LUMP) [ Time Frame: Year 1 ]
  • Eating Assessment Tool-10 (EAT-10) [ Time Frame: Year 1 ]
  • Voice Handicap Index-10 (VHI-10) [ Time Frame: Year 1 ]
  • Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Year 1 ]
  • Numeric Rating Scale for throat pain [ Time Frame: Year 1 ]

Central Contacts and Locations

Central contacts

Lyndsay Madden, DO

(336) 716-4161lmadden@wakehealth.edu

Kathryn Ruckart, MS

336.713.2657kathryn.ruckart@wakehealth.edu

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Lyndsay Madden, DO

336-716-4161lmadden@wakehealth.edu

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Aug 28, 2026

Last verified

Dec, 2025

Keywords

  • Speech-language pathologist
  • laryngeal hygiene
  • voice therapy techniques

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-08-28.