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Home-based SSP on Individuals With PWS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03871751
Recruitment Status : Terminated (Insufficient resources to complete study as planned)
First Posted : March 12, 2019
Last Update Posted : March 7, 2022
Integrated Listening Systems
Information provided by (Responsible Party):
Jacek Kolacz, Indiana University

Brief 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.

Condition or disease Intervention/treatment Phase
Prader-Willi Syndrome Behavioral: Safe and Sound Protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Child participants must meet criteria for Prader-Willi Syndrome (per parent membership in Prader-Willi Parent Support Group).
  2. Child participants must be between ages 3-17 years. Parent must be 18 years or older.
  3. Child participants must have normal hearing (confirmed via parental report on Qualtrics questionnaire)

Exclusion Criteria:

1) Child participants who are hearing-impaired (without correction)

Information from the National Library of Medicine

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 identifier (NCT number): NCT03871751

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United States, Colorado
Integrated Listening Systems
Aurora, Colorado, United States, 80014
Sponsors and Collaborators
Indiana University
Integrated Listening Systems
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Principal Investigator: Jacek Kolacz, PhD Indiana University/Kinsey Institute
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Responsible Party: Jacek Kolacz, Assistant Research Scientist, Indiana University Identifier: NCT03871751    
Other Study ID Numbers: 1807300643
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 7, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jacek Kolacz, Indiana University:
Polyvagal Theory
Social Behavior
Auditory intervention
Additional relevant MeSH terms:
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Prader-Willi Syndrome
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Nutrition Disorders