[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07719582":3,"trial-entities:NCT07719582":122,"trial-summary:NCT07719582":127},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":39,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":47,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":57,"locations":61,"central_contacts":77,"overall_officials":79,"references":80,"see_also_links":106},"NCT07719582","P1821","Effectivity of P1821, a Novel Tongue Strengthening and Endurance Enhancing Speech Flow Exercise","NOT_YET_RECRUITING","2030-01-01","2026-07","2026-07-22","2028-01-01","Dream Video LLC","OTHER",false,"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.","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.\n\nThe 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.\n\nThe 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:\n\nFrom front to back, from the sides to the middle, and from top to bottom.\n\nThis 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).",[18,19,20],"Ankyloglossia","Impairment of Speech","Slurred Speech",[22,23,24,25],"Tongue-strengthening self-exercises (TSsE)","Tongue strength","Home-based exercise","Self-exercise","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},100,"ESTIMATED",[34],{"type":35,"name":5,"description":36,"armGroupLabels":37},"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.",[38],"P1821 #1",[40,43],{"measure":5,"description":41,"timeFrame":42},"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.",{"measure":5,"description":44,"timeFrame":42},"Compare the number of participants experiencing treatment-related adverse events versus those with positive treatment outcomes.",[],"ALL",null,true,{"inclusion":50,"exclusion":53,"raw_text":56},[51,52],"Can read and write","Willing and able to follow the requirements of the protocol",[54,55],"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","Inclusion Criteria:\n\n* Can read and write\n* Willing and able to follow the requirements of the protocol\n\nExclusion Criteria:\n\n* Previously seen and treated by speech and language pathologist for dysphagia or dysarthria for non-head and neck cancer causes\n* Medical instability, restlessness, or other factors that would compromise data acquisition",[58,59,60],"CHILD","ADULT","OLDER_ADULT",[62],{"facility":63,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":74},"N\u002FA - Remote Study","Naples","Florida","34119","United States",[69],{"name":70,"role":71,"phone":72,"email":73},"Matthew Quitto II","CONTACT","917-342-2895","dream@dreamholdingsllc.com",{"lat":75,"lon":76},26.14234,-81.79596,[78],{"name":70,"role":71,"phone":72,"email":73},[],[81,85,88,91,94,97,100,103],{"pmid":82,"type":83,"citation":84},"27552110","BACKGROUND","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\u002F2016_AJSLP-15-0100.",{"pmid":86,"type":83,"citation":87},"31136240","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\u002F2018_AJSLP-18-0023. Epub 2019 Feb 28.",{"pmid":89,"type":83,"citation":90},"12748571","Lalakea ML, Messner AH. Ankyloglossia: the adolescent and adult perspective. Otolaryngol Head Neck Surg. 2003 May;128(5):746-52. doi: 10.1016\u002FS0194-59980300258-4.",{"pmid":92,"type":83,"citation":93},"33964037","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\u002Fipd.12802. Epub 2021 May 22.",{"pmid":95,"type":83,"citation":96},"30152627","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\u002Fdmp\u002F85708.",{"pmid":98,"type":83,"citation":99},"32427523","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\u002F0194599820925415. Epub 2020 May 19.",{"pmid":101,"type":83,"citation":102},"19656020","Suter VG, Bornstein MM. Ankyloglossia: facts and myths in diagnosis and treatment. J Periodontol. 2009 Aug;80(8):1204-19. doi: 10.1902\u002Fjop.2009.090086.",{"pmid":104,"type":83,"citation":105},"28715533","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\u002Fjamaoto.2017.0948.",[107,110,113,116,119],{"label":108,"url":109},"Effects of Tongue-Strengthening Self-Exercises in Healthy Older Adults: A Non-Randomized Controlled Trial","https:\u002F\u002Fpmc.ncbi.nlm.nih.gov\u002Farticles\u002FPMC8464581\u002F",{"label":111,"url":112},"In brief: How does the tongue work?","https:\u002F\u002Fwww.ncbi.nlm.nih.gov\u002Fbooks\u002FNBK279407\u002F",{"label":114,"url":115},"Evolution of the human tongue and emergence of speech biomechanics","https:\u002F\u002Fpmc.ncbi.nlm.nih.gov\u002Farticles\u002FPMC10266234\u002F",{"label":117,"url":118},"National Library of Medicine","https:\u002F\u002Fmedlineplus.gov\u002Fency\u002Farticle\u002F007470.htm",{"label":120,"url":121},"Ankyloglossia (Tongue-Tie)","https:\u002F\u002Fwww.ncbi.nlm.nih.gov\u002Fbooks\u002FNBK482295\u002F",{"nct_id":4,"conditions":123,"biomarkers":126},[18,124,125],"Disturbance in speech","Dysarthria",[],{"nct_id":4,"found":48,"summary":128,"prompt_version":138},{"design":129,"status":130,"heading":131,"summary":132,"follow_up":133,"word_count":134,"commitments":135,"compensation":136,"drugs_mentioned":137},"This is an interventional study planning to enroll 100 participants. The phase of the study is not specified.","completed","P1821 for Ankyloglossia and Speech Impairment","This study is investigating P1821, a device designed to strengthen your tongue muscles and improve endurance. It works by using muscle resistance training, without medicines or electronic parts. The goal is to see if this tongue exercise can help improve how clearly you speak, especially if you have conditions like ankyloglossia (tongue-tie) or slurred speech. They plan to enroll 100 participants who can read and write and are able to follow the study's instructions. You cannot join if you've previously had speech therapy for swallowing or speaking difficulties not related to head and neck cancer, or if you have other medical issues that would make it hard to collect accurate information.","The primary endpoints are measured at the end of treatment at 2 weeks. It is not specified if there is follow-up after this period.",111,"The P1821 intervention will be used from enrollment to the end of treatment at 2 weeks. The trial record does not specify the frequency of visits or procedures.","Not stated in the trial record.",[5],"v2"]