NCT03871751

Home-based SSP on Individuals With PWS

Terminated NA Last updated 7 March 2022

What this trial tests

NA trial testing Safe and Sound Protocol in Prader-Willi Syndrome in 10 participants. Terminated before completion.

Timeline

8 April 2019

Primary endpoint
16 December 2019

16 December 2019

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	10
Start date	8 April 2019
Primary completion	16 December 2019
Estimated completion	16 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Safe and Sound Protocol

Conditions studied

• Prader-Willi Syndrome — all drugs for Prader-Willi Syndrome →

Sponsor

Indiana University

Who can join

Adults 3 to 17, any sex, with Prader-Willi Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.