Recruiting

P1821

Sponsor:

Dream Video LLC

Code:

NCT07719582

Conditions

Ankyloglossia

Impairment of Speech

Slurred Speech

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

P1821

Study Details

Brief summary:

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.

Conditions

Ankyloglossia

Impairment of Speech

Slurred Speech

Study ID

NCT07719582

Start date

Nov 1, 2026

Status verified date

Nov, 2026

Completion date

Jan 1, 2030

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: P1821 #1

P1821 interventions are administered once daily over a period of fourteen days.

Interventions

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.

Primary outcome measure

  • P1821 [ Time Frame: From enrollment to the end of treatment at 2 weeks. ]
  • P1821 [ Time Frame: From enrollment to the end of treatment at 2 weeks. ]

Central Contacts and Locations

Central contacts

Matthew Quitto II

917-342-2895dream@dreamholdingsllc.com

Locations

N/A - Remote Study

Recruiting

Naples, Florida, United States, 34119

Contacts

Matthew Quitto II

917-342-2895dream@dreamholdingsllc.com

More Information

Sponsor

Dream Video LLC

Last update posted

Nov 4, 2026

Last verified

Nov, 2026

Keywords

  • Tongue-strengthening self-exercises (TSsE)
  • Tongue strength
  • Home-based exercise
  • Self-exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by Dream Video LLC on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.