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NCT Number: NCT07719582

Effectivity of P1821, a Novel Tongue Strengthening and Endurance Enhancing Speech Flow Exercise

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Can read and write
  • Willing and able to follow the requirements of the protocol

Exclusion criteria

  • Previously seen and treated by speech and language pathologist for dysphagia or dysarthria for non-head and neck cancer causes
  • Medical instability, restlessness, or other factors that would compromise data acquisition

Treatment and study plan

P1821

Device

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.

Primary outcomes

  1. P1821

    Time frame: From 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.

  2. P1821

    Time frame: From 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Quitto II

CONTACT

[email protected]

917-342-2895

Sponsors and collaborators

Lead sponsor

Dream Video LLC

Other

Collaborators

  • Dream Holdings Research

Registry information

Important dates

Study start
2028
Primary completion
2029
Study completion
2030
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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