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

Part of paid clinical trials in Naples, Florida.

Sponsor
Dream Video LLC
Study ID
NCT07719582
Status
Not Yet Recruiting

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Conditions

  • Ankyloglossia
  • Impairment of Speech
  • Slurred Speech

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jul 22, 2026
Start date
Jan 1, 2028
Status verified
Jul 2026
Primary completion
Jan 1, 2029
Completion
Jan 1, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: P1821 #1
    P1821 interventions are administered once daily over a period of fourteen days.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
N/A - Remote StudyNaplesFlorida34119
Matthew Quitto II
917-342-2895

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