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NCT05464225 · ClinicalTrials.gov registry record · NA
Colorado Oral Strengthening Device
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT05464225: Completed NA study, sponsored by University of Colorado, Denver.
NCT05464225 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05464225, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
Study Summary
University of Colorado is looking for adults with Parkinson's disease to participate in a research study. The study aims to explore how a novel low technology device can achieve an increase in tongue strength comparable to standard of care exercise using tongue depressors but with the kinematics and simple biofeedback of existing high cost devices. Research has shown that tongue resistance exercises paired with biofeedback have resulted in improved tongue strength to support chewing, control of food and liquid in the mouth, and propulsion of material for a swallow.
Primary Outcome
Tongue Strength, as measured in kPa via IOPI with measurements that are equal to or higher compared to baseline at follow-up visits at weeks 2,3,6 and 8 from initial visit. Tongue strength will be assessed using The Iowa Oral Pressure Instrument (IOPI). IOPI measures tongue strength with max pressure (kPa) ranging from 0 to 110 with an average of 50-60 kPa depending on age. Higher kPa is associated with increased tongue strength.
Interventions
- DEVICE COSD
- DEVICE SOC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2023-03-15 |
| Est. Completion | 2025-03-10 |
| Phase | NA |
What the finished NCT05464225 record still lists
NCT05464225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which COSD is the first listed.
NCT05464225 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05464225 about?
NCT05464225 is a clinical study titled "Colorado Oral Strengthening Device". University of Colorado is looking for adults with Parkinson's disease to participate in a research study. The study aims to explore how a novel low technology device can achieve an increase in tongue strength comparable to standard of care exercise using tongue depressors but with the kinematics and...
What is the current status of trial NCT05464225?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2023-03-15. Estimated completion is 2025-03-10.
What interventions are being tested in trial NCT05464225?
The interventions under investigation include: COSD (DEVICE), SOC (DEVICE).
Who is sponsoring clinical trial NCT05464225?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05464225's enrollment target sits among peer trials
39 1536th of 2000 higher than 463 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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