- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07595315
Foundations for Prescribing Song-Based Therapies: A Quantitative Comparison of Laryngeal Exercises (SINGS)
May 12, 2026 updated by: University of Kansas Medical Center
SINGS explores the therapeutic potential of song-based exercises for treating dysphagia in geriatric populations.
The project aims to compare the effectiveness of song-based tasks with traditional speech-language pathology (SLP) exercises using advanced tools such as surface electromyography (sEMG) and functional neuroimaging.
In addition to quantifying functional activity during therapy, the study will assess patient compliance, satisfaction, and long-term swallowing outcomes, with a focus on improving quality of life through innovative, enjoyable therapies.
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy Adults
Exclusion Criteria:
- History of head and neck cancer, radiation to the neck, and/or other head and neck based surgeries*
Formal Dysphagia diagnosis*
- Formal GERD diagnosis*
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Healthy cohort without prescribed dysphagia
This cohort of healthy individuals will help establish mechanisms of therapy protocols to apply in future studies on target population.
|
The SINGS arm will be completed by all members in the cohort.
Other Names:
|
|
Experimental: SINGS Intervention
The SINGS arm will be completed by all members in the cohort.
|
The SINGS arm will be completed by all members in the cohort.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Activation
Time Frame: Day 1 (single 90-minute study visit)
|
Surface EMG readings between SBT and SLP tasks.
|
Day 1 (single 90-minute study visit)
|
|
EEG
Time Frame: Day 1 (single 90-minute study visit)
|
Similar regional neural activity measured by EEG between SBT and SLP tasks.
|
Day 1 (single 90-minute study visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EAT-10 Total Score
Time Frame: Day 1 (single study visit)
|
Total score on the Eating Assessment Tool (EAT-10) questionnaire
|
Day 1 (single study visit)
|
|
Self-reported tobacco and e-cigarette use
Time Frame: Day 1 (single study visit); assesses past 30 days and lifetime history as applicable
|
Self-reported tobacco and e-cigarette use variables (e.g., days used in past 30 days; cigarettes per day; quit attempts; age of initiation)
|
Day 1 (single study visit); assesses past 30 days and lifetime history as applicable
|
|
Patient Satisfaction Survey
Time Frame: Day 1 (single study visit)
|
Likert-scale responses (1-5) on satisfaction, convenience, enjoyment, ease, and confidence comparing song-based tasks to SLP tasks
|
Day 1 (single study visit)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jennifer Villwock, MD, University of Kansas Medical Center
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 Major Dates
Study Start (Estimated)
June 1, 2025
Primary Completion (Estimated)
October 15, 2025
Study Completion (Estimated)
December 15, 2025
Study Registration Dates
First Submitted
November 20, 2024
First Submitted That Met QC Criteria
May 12, 2026
First Posted (Actual)
May 19, 2026
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 12, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SINGS TL1
- TL1TR002368 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
It is not yet known if there will be a plan to make IPD available.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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