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Listening Project Protocol for Prader-Willi Syndrome

N/A
Waitlist Available
Led By Stephen W Porges, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from 1 week pre-intervention vasopressin to 1 month post-intervention
Awards & highlights

Study Summary

This trial will test whether the Listening Project Protocol, designed as a neural exercise of the Social Engagement System, can improve the atypical features of the Social Engagement System in adolescents with Prader-Willi Syndrome.

Eligible Conditions
  • Prader-Willi Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from 1 week pre-intervention heart period to 1 week post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from 1 week pre-intervention heart period to 1 week post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of Intervention on Autonomic regulation
Secondary outcome measures
Effect of Intervention on Accuracy of Affect recognition
Effect of Intervention on Auditory processing
Effect of Intervention on Disruptive Behavior
+7 more
Other outcome measures
Immediate effects of intervention on Accuracy of Affect recognition
Immediate effects of intervention on Auditory processing
Immediate effects of intervention on Autonomic regulation
+21 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Filtered Music InterventionExperimental Treatment1 Intervention
All participants will participate in pre-intervention assessments (6 months, 1 week prior) and post-intervention assessments (1 week, 1 month post). The Filtered Music Intervention (i.e., Listening Project Protocol) will last for 1 hour per day, for 5 consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Listening Project Protocol
2018
N/A
~90

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
979 Previous Clinical Trials
983,011 Total Patients Enrolled
1 Trials studying Prader-Willi Syndrome
10 Patients Enrolled for Prader-Willi Syndrome
Latham CentersUNKNOWN
Stephen W Porges, PhDPrincipal InvestigatorIndiana University/Kinsey Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
International Journal of PsychophysiologyJournal
Respiratory Sinus Arrhythmia and Auditory Processing in Autism: Modifiable Deficits of an Integrated Social Engagement System?
Porges, Stephen W., Matthew Macellaio, Shannon D. Stanfill, Kimberly McCue, Gregory F. Lewis, Emily R. Harden, Mika Handelman, John Denver, Olga V. Bazhenova, and Keri J. Heilman. 2013. “Respiratory Sinus Arrhythmia and Auditory Processing in Autism: Modifiable Deficits of an Integrated Social Engagement System?”. International Journal of Psychophysiology. Elsevier BV. doi:10.1016/j.ijpsycho.2012.11.009.
Frontiers in PediatricsJournal
Reducing Auditory Hypersensitivities in Autistic Spectrum Disorder: Preliminary Findings Evaluating the Listening Project Protocol
Porges, Stephen W., Olga V. Bazhenova, Elgiz Bal, Nancy Carlson, Yevgeniya Sorokin, Keri J. Heilman, Edwin H. Cook, and Gregory F. Lewis. 2014. “Reducing Auditory Hypersensitivities in Autistic Spectrum Disorder: Preliminary Findings Evaluating the Listening Project Protocol”. Frontiers in Pediatrics. Frontiers Media SA. doi:10.3389/fped.2014.00080.
clinicaltrials.govStudy
Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory
Stephen Porges 2017. "Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03101826.
~1 spots leftby Apr 2025
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