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NCT03101826 · ClinicalTrials.gov registry record · NA
Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory
A NA study, sponsored by Indiana University.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT03101826: Clinical Trial NA study, sponsored by Indiana University.
NCT03101826 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03101826, a NA study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 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. We propose to confirm that several features of the behavioral phenotype of PWS may be explained within the context of a dysfunctional SES (Specific Aim I), which may be partially rehabilitated via an intervention designed as a 'neural exercise' of the SES (Specific Aim II). Specific Aims: Aim I: To demonstrate that children with PWS have atypical regulation of the SES. We hypothesize these effects will be manifested by dampened vagal regulation of the heart (low parasympathetic tone); poor middle ear muscle regulation resulting in auditory hypersensitivities and poor auditory processing; lack of voice intonation (prosody), and difficulties in accurately detecting the emotions of others. Aim II: To demonstrate th
Primary Outcome
Respiratory sinus arrhythmia (RSA)
Interventions
- BEHAVIORAL Listening Project Protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2023-03-08 |
| Phase | NA |
Why NCT03101826 stopped before completion
NCT03101826 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Listening Project Protocol is the first listed.
NCT03101826 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03101826 about?
NCT03101826 is a clinical study titled "Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory". 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 NCT03101826?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2017-11-01. Estimated completion is 2023-03-08.
What interventions are being tested in trial NCT03101826?
The interventions under investigation include: Listening Project Protocol (BEHAVIORAL).
Who is sponsoring clinical trial NCT03101826?
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 NCT03101826's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 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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