AnkyloglossiaNCT07719582
Effectivity of P1821, a Novel Tongue Strengthening and Endurance Enhancing Speech Flow Exercise
A study testing P1821 in people with Ankyloglossia and Impairment of Speech, run by Dream Video LLC at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ankyloglossia, Impairment of Speech, Slurred Speech
- What is being tested?
- P1821
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Can read and write
- Willing and able to follow the requirements of the protocol
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
N/A - Remote Study
Naples, Florida, 34119
Matthew Quitto II, 917-342-2895, dream@dreamholdingsllc.com
About this study
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.
Read the detailed description
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).
- Conditions
- Ankyloglossia, Impairment of Speech, Slurred Speech
- Being tested
- P1821
- Keywords
- Tongue-strengthening self-exercises (TSsE), Tongue strength, Home-based exercise, Self-exercise
- Medical subject headings
- Ankyloglossia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P1821Device
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 group | Role | What they receive |
|---|---|---|
| P1821 #1 | Experimental | P1821 interventions are administered once daily over a period of fourteen days. Receives: Device: P1821 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of treatment at 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Nov 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AnkyloglossiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All study participants will get the same intervention.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dream Video LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Dream Holdings Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719582
- Sponsor's protocol ID
- P1821
- Status last verified
- Nov 2026
- First submitted
- 18 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27552110Potter 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.
PubMed 31136240Lalakea 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.
PubMed 12748571Wang 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.
PubMed 33964037Belmehdi 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.
PubMed 30152627Wei 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.
PubMed 32427523Suter 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.
PubMed 19656020Walsh 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.
PubMed 28715533
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity of P1821, a Novel Tongue Strengthening and Endurance Enhancing Speech Flow Exercise
- ClinicalTrials.gov ID
- NCT07719582
- Acronym / sponsor ID
- P1821
- Conditions
- Ankyloglossia, Impairment of Speech, Slurred Speech
- Keywords
- Tongue-strengthening self-exercises (TSsE), Tongue strength, Home-based exercise, Self-exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dream Video LLCUniversity, hospital or other
- Collaborators
- Dream Holdings Research
- Study start
- 1 Nov 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All study participants will get the same intervention.
| Arm | Type | Receives |
|---|---|---|
| P1821 #1 | Experimental | Device: P1821P1821 interventions are administered once daily over a period of fourteen days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Can read and write
- Willing and able to follow the requirements of the protocol
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P1821The 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. | Device | P1821 #1 |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 27552110Binger 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.
- Background: PubMed 31136240Potter 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.
- Background: PubMed 12748571Lalakea 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.
- Background: PubMed 33964037Wang 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.
- Background: PubMed 30152627Belmehdi 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.
- Background: PubMed 32427523Wei 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.
- Background: PubMed 19656020Suter 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.
- Background: PubMed 28715533Walsh 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.
- Effects of Tongue-Strengthening Self-Exercises in Healthy Older Adults: A Non-Randomized Controlled TrialLink provided by the sponsor.
- In brief: How does the tongue work?Link provided by the sponsor.
- Evolution of the human tongue and emergence of speech biomechanicsLink provided by the sponsor.
- National Library of MedicineLink provided by the sponsor.
- Ankyloglossia (Tongue-Tie)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P1821 in people with Ankyloglossia and Impairment of Speech, run by Dream Video LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Quitto II (917-342-2895, dream@dreamholdingsllc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P1821 (time frame: From enrollment to the end of treatment at 2 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07719582, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.