NCT07595315

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

November 20, 2024

Last Update Submit

May 12, 2026

Conditions

Keywords

Song-based therapyMusic therapySurface EMGEEG

Outcome Measures

Primary Outcomes (2)

  • Muscle Activation

    Surface EMG readings between SBT and SLP tasks.

    Day 1 (single 90-minute study visit)

  • EEG

    Similar regional neural activity measured by EEG between SBT and SLP tasks.

    Day 1 (single 90-minute study visit)

Secondary Outcomes (3)

  • EAT-10 Total Score

    Day 1 (single study visit)

  • Self-reported tobacco and e-cigarette use

    Day 1 (single study visit); assesses past 30 days and lifetime history as applicable

  • Patient Satisfaction Survey

    Day 1 (single study visit)

Study Arms (2)

Healthy cohort without prescribed dysphagia

PLACEBO COMPARATOR

This cohort of healthy individuals will help establish mechanisms of therapy protocols to apply in future studies on target population.

Other: Dysphagia Treatment Protocol

SINGS Intervention

EXPERIMENTAL

The SINGS arm will be completed by all members in the cohort.

Other: Dysphagia Treatment Protocol

Interventions

The SINGS arm will be completed by all members in the cohort.

Also known as: SINGS
Healthy cohort without prescribed dysphagiaSINGS Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Adults

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Jennifer Villwock, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Participants are prospectively assigned to perform predefined speech-language pathology exercises and song-based tasks during a single study visit while EEG and surface EMG are recorded for mechanistic comparison. This is a basic science / physiologic study conducted in healthy adults with a cross-sectional, single-visit (\~90 minutes) design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2024

First Posted

May 19, 2026

Study Start

June 1, 2025

Primary Completion

October 15, 2025

Study Completion

December 15, 2025

Last Updated

May 19, 2026

Record last verified: 2026-05