NCT03871751

Home-based SSP on Individuals With PWS

Evaluating the Effectiveness of Home-based SSP on Individuals With PWS

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Safe and Sound Protocol	The auditory intervention will consist of listening to computer-altered acoustic stimulation, designed to modulate the frequency band of vocal music passed to the participant. The frequency characteristics of the acoustic stimulation are selected to emphasize the relative importance of specific frequencies in conveying the information embedded in human speech. Modulation of the acoustic energy within the frequencies of human voice, similar to an exaggerated vocal prosody, are hypothesized to recruit and modulate the neural regulation of the middle ear muscles and to functionally reduce sound hypersensitivities and improve auditory processing.

Timeline

• Start date: 2019-04-08
• Primary completion: 2019-12-16
• Completion: 2019-12-16
• First posted: 2019-03-12
• Last updated: 2022-03-07

Locations

1 site across 1 country: United States