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

NCT07719582 | Not Yet Recruiting

• 1 other identifier: P1821
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrollment to the end of treatment at 2 weeks.

Study Arms (1)

P1821 #1

EXPERIMENTAL

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

Device: P1821

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.

P1821 #1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dream Video LLC: lead
• Dream Holdings Research: collaborator

Study Sites (1)

N/A - Remote Study

Naples, Florida, 34119, United States

Location

Related Publications (8)

• Binger C, Ragsdale J, Bustos A. Language Sampling for Preschoolers With Severe Speech Impairments. Am J Speech Lang Pathol. 2016 Nov 1;25(4):493-507. doi: 10.1044/2016_AJSLP-15-0100.

  PMID: 27552110 BACKGROUND

• Potter NL, Nievergelt Y, VanDam M. Tongue Strength in Children With and Without Speech Sound Disorders. Am J Speech Lang Pathol. 2019 May 27;28(2):612-622. doi: 10.1044/2018_AJSLP-18-0023. Epub 2019 Feb 28.

  PMID: 31136240 BACKGROUND

• Lalakea ML, Messner AH. Ankyloglossia: the adolescent and adult perspective. Otolaryngol Head Neck Surg. 2003 May;128(5):746-52. doi: 10.1016/S0194-59980300258-4.

  PMID: 12748571 BACKGROUND

• Wang J, Yang X, Hao S, Wang Y. The effect of ankyloglossia and tongue-tie division on speech articulation: A systematic review. Int J Paediatr Dent. 2022 Mar;32(2):144-156. doi: 10.1111/ipd.12802. Epub 2021 May 22.

  PMID: 33964037 BACKGROUND

• Belmehdi A, Harti KE, Wady WE. Ankyloglossia as an oral functional problem and its surgical management. Dent Med Probl. 2018 Apr-Jun;55(2):213-216. doi: 10.17219/dmp/85708.

  PMID: 30152627 BACKGROUND

• Wei EX, Tunkel D, Boss E, Walsh J. Ankyloglossia: Update on Trends in Diagnosis and Management in the United States, 2012-2016. Otolaryngol Head Neck Surg. 2020 Nov;163(5):1029-1031. doi: 10.1177/0194599820925415. Epub 2020 May 19.

  PMID: 32427523 BACKGROUND

• Suter VG, Bornstein MM. Ankyloglossia: facts and myths in diagnosis and treatment. J Periodontol. 2009 Aug;80(8):1204-19. doi: 10.1902/jop.2009.090086.

  PMID: 19656020 BACKGROUND

• Walsh J, Tunkel D. Diagnosis and Treatment of Ankyloglossia in Newborns and Infants: A Review. JAMA Otolaryngol Head Neck Surg. 2017 Oct 1;143(10):1032-1039. doi: 10.1001/jamaoto.2017.0948.

  PMID: 28715533 BACKGROUND

Related Links

• Effects of Tongue-Strengthening Self-Exercises in Healthy Older Adults: A Non-Randomized Controlled Trial
• In brief: How does the tongue work?
• Evolution of the human tongue and emergence of speech biomechanics
• National Library of Medicine
• Ankyloglossia (Tongue-Tie)

MeSH Terms

Conditions

Ankyloglossia

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Central Study Contacts

Matthew Quitto II

CONTACT

917-342-2895; dream@dreamholdingsllc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All study participants will get the same intervention.

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): January 1, 2028
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)