Home-based SSP on Individuals With PWS

NCT03871751 | Terminated

• 1 other identifier: 1807300643
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Prader-Willi Syndrome

Keywords

Polyvagal Theory; Social Behavior; Hyperacusis; Prosody; Auditory intervention

Outcome Measures

Primary Outcomes (1)

• Change from baseline in sensory sensitivities at 1 week

  Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)

  pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)

Secondary Outcomes (4)

• Change from baseline in disruptive behavior at 1 week

  pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)

• Change from baseline in social behavior at 1 week

  post-intervention (within 1 week after intervention)

• Change from baseline in Foundational Abilities (balance, gross & fine motor control, sensory, social/emotional, auditory/language and attention/organization and sleep) at 1 week

  pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)

• Change from baseline in prosody at 1 week

  pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)

Study Arms (1)

Safe and Sound Protocol

EXPERIMENTAL

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

Interventions

Safe and Sound Protocol BEHAVIORAL

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.

Also known as: Listening Project Protocol

Safe and Sound Protocol

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• \) Child participants who are hearing-impaired (without correction)

Sponsors & Collaborators

• Indiana University: lead
• Integrated Listening Systems: collaborator

Study Sites (1)

Integrated Listening Systems

Aurora, Colorado, 80014, United States

Location

Related Publications (2)

• Porges SW. The polyvagal theory: phylogenetic substrates of a social nervous system. Int J Psychophysiol. 2001 Oct;42(2):123-46. doi: 10.1016/s0167-8760(01)00162-3.

  PMID: 11587772 BACKGROUND

• Porges SW, Bazhenova OV, Bal E, Carlson N, Sorokin Y, Heilman KJ, Cook EH, Lewis GF. Reducing auditory hypersensitivities in autistic spectrum disorder: preliminary findings evaluating the listening project protocol. Front Pediatr. 2014 Aug 1;2:80. doi: 10.3389/fped.2014.00080. eCollection 2014.

  PMID: 25136545 BACKGROUND

MeSH Terms

Conditions

Prader-Willi Syndrome; Social Behavior; Hyperacusis

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacek Kolacz, PhD

  Indiana University/Kinsey Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Scientist

Model Details: All participants will receive the auditory intervention.

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: March 12, 2019
• Study Start: April 8, 2019
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: March 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)