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NCT03871751 · ClinicalTrials.gov registry record · NA
Home-based SSP on Individuals With PWS
A NA study, sponsored by Indiana University.
- Terminated
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT03871751: Clinical Trial NA study, sponsored by Indiana University.
NCT03871751 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03871751, a NA study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
The Polyvagal Theory focuses on how function and structure changed in the vertebrate autonomic nervous system during evolution. The theory is named for the vagus, a major cranial nerve that regulates bodily state. As a function of evolution, humans and other mammals have a "new" vagal pathway that links the regulation of bodily state to the control of the muscles of the face and head including the middle ear muscles. These pathways regulating body state, facial gesture, listening (i.e., middle ear muscles), and vocal communication collectively function as a Social Engagement System (SES). Because the Social Engagement System is an integrated system, interventions influencing one component of this system (e.g., middle ear muscles) may impact on the other components. Individuals with Prader-Willi Syndrome (PWS) exhibit many behaviors that are consistent with a compromised Social Engagement System. Atypical function of the Social Engagement System results in problems associated with state regulation (e.g., impulsivity, tantrums, and difficulty with change in routine), ingestion (e.g., difficulties in sucking at birth, hyperphagia), coordination of suck/swallow/breathe, intonation of vocalizations, auditory processing and hypersensitivity, and socialization. The investigatiors propose to confirm that several features of the behavioral phenotype of PWS may be explained within the context of a dysfunctional SES, which may be partially rehabilitated via an intervention designed as a 'neural exercise' of the SES (i.e., the Safe and Sound Protocol, "SSP"). Specific Aims: Aim I: To demonstrate the effectiveness of the Safe and Sound Protocol (SSP) on improvement of social and regulation behaviors in individuals with PWS. Aim II: To evaluate a new methodology for collecting and evaluating vocal samples for analyses of prosody, one of the indices of the functioning of the SES.
Primary Outcome
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
Interventions
- BEHAVIORAL Safe and Sound Protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-04-08 |
| Est. Completion | 2019-12-16 |
| Phase | NA |
Why NCT03871751 stopped before completion
NCT03871751 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Safe and Sound Protocol is the first listed.
NCT03871751 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03871751 about?
NCT03871751 is a clinical study titled "Home-based SSP on Individuals With PWS". The Polyvagal Theory focuses on how function and structure changed in the vertebrate autonomic nervous system during evolution. The theory is named for the vagus, a major cranial nerve that regulates bodily state. As a function of evolution, humans and other mammals have a "new" vagal pathway that l...
What is the current status of trial NCT03871751?
This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2019-04-08. Estimated completion is 2019-12-16.
What interventions are being tested in trial NCT03871751?
The interventions under investigation include: Safe and Sound Protocol (BEHAVIORAL).
Who is sponsoring clinical trial NCT03871751?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03871751's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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