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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 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 10 participants.

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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.

Interventions

  • BEHAVIORAL Safe and Sound Protocol

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2019-04-08
Est. Completion 2019-12-16
Phase NA

Sponsor

Indiana University

890 total trials

What the Registry Record Tells You About NCT03871751

The ClinicalTrials.gov registry entry for NCT03871751 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Safe and Sound Protocol is the first listed.

NCT03871751 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.