Home-based SSP on Individuals With PWS
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|ClinicalTrials.gov Identifier: NCT03871751|
Recruitment Status : Terminated (Insufficient resources to complete study as planned)
First Posted : March 12, 2019
Last Update Posted : March 7, 2022
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").
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.
|Condition or disease||Intervention/treatment||Phase|
|Prader-Willi Syndrome||Behavioral: Safe and Sound Protocol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants will receive the auditory intervention.|
|Masking:||None (Open Label)|
|Masking Description:||No masking.|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluating the Effectiveness of Home-based SSP on Individuals With PWS|
|Actual Study Start Date :||April 8, 2019|
|Actual Primary Completion Date :||December 16, 2019|
|Actual Study Completion Date :||December 16, 2019|
Experimental: Safe and Sound Protocol
All child participants will participate in 1 pre-intervention assessment and 1 post-intervention assessment. The auditory intervention (i.e., Safe and Sound Protocol, SSP) will last for 1 hour per day, for 5 consecutive days.
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.
Other Name: Listening Project Protocol
- Change from baseline in sensory sensitivities at 1 week [ Time Frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention) ]Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
- Change from baseline in disruptive behavior at 1 week [ Time Frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention) ]Developmental Behavior Checklist (DBC2) (questionnaire)
- Change from baseline in social behavior at 1 week [ Time Frame: post-intervention (within 1 week after intervention) ]Safe and Sound Protocol (SSP) Parent Questionnaire
- Change from baseline in Foundational Abilities (balance, gross & fine motor control, sensory, social/emotional, auditory/language and attention/organization and sleep) at 1 week [ Time Frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention) ]Measure of Foundational Abilities (MFA) questionnaire
- Change from baseline in prosody at 1 week [ Time Frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention) ]Prosody assessment of recorded speech
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871751
|United States, Colorado|
|Integrated Listening Systems|
|Aurora, Colorado, United States, 80014|
|Principal Investigator:||Jacek Kolacz, PhD||Indiana University/Kinsey Institute|