P1821 for Ankyloglossia and Speech Impairment
This study is investigating P1821, a device designed to strengthen your tongue muscles and improve endurance. It works by using muscle resistance training, without medicines or electronic parts. The goal is to see if this tongue exercise can help improve how clearly you speak, especially if you have conditions like ankyloglossia (tongue-tie) or slurred speech. They plan to enroll 100 participants who can read and write and are able to follow the study's instructions. You cannot join if you've previously had speech therapy for swallowing or speaking difficulties not related to head and neck cancer, or if you have other medical issues that would make it hard to collect accurate information.
- Study design
- This is an interventional study planning to enroll 100 participants. The phase of the study is not specified.
- What's involved
- The P1821 intervention will be used from enrollment to the end of treatment at 2 weeks. The trial record does not specify the frequency of visits or procedures.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at the end of treatment at 2 weeks. It is not specified if there is follow-up after this period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Effectivity of P1821, a Novel Tongue Strengthening and Endurance Enhancing Speech Flow Exercise
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- P1821From enrollment to the end of treatment at 2 weeks.
The primary key performance indicator will be the proportion of study participants who demonstrate statistically significant and measurable improvements in their speaking ability following the completion of the two-week treatment protocol within P1821. This metric is crucial for evaluating the efficacy of the intervention and will be assessed through standardized linguistic and speech pathology evaluations.
- P1821From enrollment to the end of treatment at 2 weeks.
Compare the number of participants experiencing treatment-related adverse events versus those with positive treatment outcomes.