An interventional study of P1821 in Ankyloglossia, Impairment of Speech and Slurred Speech, sponsored by Dream Video LLC. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Dream Video LLC · Not applicable, Interventional, and Treatment
The P1821 initiative constitutes an innovative intervention specifically engineered to enhance tongue muscular strength and endurance. The primary objective of this research study is to ascertain whether the integration of a proactive tongue strengthening exercise regimen, utilizing a Non-Significant Risk (NSR) Device, contributes to an observable improvement in speech fluency.
P1821 specifically targets the muscles in the tongue. These areas are part of the tongue's movable section, known for their great flexibility and ability to perform complex movements.
The tongue plays a crucial role in speech production. Weakness in its muscles can lead to difficulties in speaking clearly and distinctly. The tongue is a highly mobile group of muscles, richly supplied with blood and nerves.
The tongue's remarkable ability to move in all directions stems from the unique arrangement of its muscle fibers, which is unlike any other muscle in the body. These fibers run in three dimensions:
From front to back, from the sides to the middle, and from top to bottom.
This unique structure allows the tongue to perform a variety of movements, including: Getting longer and shorter. The tongue is the only muscle in the body that can be actively lengthened, not just shortened. When the vertical and horizontal fibers contract simultaneously, the tongue becomes narrower and longer, enabling it to be extended. Changing its position: Additional muscles can alter the tongue's overall position by pulling it from the front (from the lower jaw), from below and behind (from the hyoid bone), and from above and behind (from the base of the skull).
32 studies on the registry are indexed under Ankyloglossia; 8 are open to participants now.
This study's planned enrollment of 100 is close to the median of 105 across 22 interventional studies indexed under Ankyloglossia.
Browse Ankyloglossia studies →Dream Video LLC is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
P1821 interventions are administered once daily over a period of fourteen days.
Device: P1821
The P1821 intervention is distinguished by its independence from pharmaceutical agents and electronic devices. Its foundational mechanism is predicated exclusively on the physiological principles of muscle resistance training, thereby offering a non-pharmacological and non-invasive therapeutic approach.
P1821
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.
Time frame: From enrollment to the end of treatment at 2 weeks.
P1821
Compare the number of participants experiencing treatment-related adverse events versus those with positive treatment outcomes.
Time frame: From enrollment to the end of treatment at 2 weeks.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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