Effectivity of P1821, a Novel Tongue Strengthening and Endurance Enhancing Speech Flow Exercise
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorDream Video LLC
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Can read and write
Willing and able to follow the requirements of the protocol
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
P1821
DeviceThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: P1821 #1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 2 weeks.2
P1821
Compare the number of participants experiencing treatment-related adverse events versus those with positive treatment outcomes.
Time frame
From enrollment to the end of treatment at 2 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dream Video LLC
Lead sponsor
Dream Holdings Research
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: