Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-01 @ 4:43 PM
Study NCT ID:
NCT03871751
Status:
TERMINATED
Last Update Posted:
2022-03-07
First Post:
2019-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-based SSP on Individuals With PWS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011218', 'term': 'Prader-Willi Syndrome'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D012001', 'term': 'Hyperacusis'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D000096803', 'term': 'Imprinting Disorders'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will receive the auditory intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Insufficient resources to complete study as planned', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-18', 'studyFirstSubmitDate': '2019-02-25', 'studyFirstSubmitQcDate': '2019-03-11', 'lastUpdatePostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in sensory sensitivities at 1 week', 'timeFrame': 'pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)', 'description': 'Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in disruptive behavior at 1 week', 'timeFrame': 'pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)', 'description': 'Developmental Behavior Checklist (DBC2) (questionnaire)'}, {'measure': 'Change from baseline in social behavior at 1 week', 'timeFrame': 'post-intervention (within 1 week after intervention)', 'description': 'Safe and Sound Protocol (SSP) Parent Questionnaire'}, {'measure': 'Change from baseline in Foundational Abilities (balance, gross & fine motor control, sensory, social/emotional, auditory/language and attention/organization and sleep) at 1 week', 'timeFrame': 'pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)', 'description': 'Measure of Foundational Abilities (MFA) questionnaire'}, {'measure': 'Change from baseline in prosody at 1 week', 'timeFrame': 'pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)', 'description': 'Prosody assessment of recorded speech'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polyvagal Theory', 'Social Behavior', 'Hyperacusis', 'Prosody', 'Auditory intervention'], 'conditions': ['Prader-Willi Syndrome']}, 'referencesModule': {'references': [{'pmid': '11587772', 'type': 'BACKGROUND', 'citation': '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': '25136545', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIndividuals 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").\n\nSpecific Aims:\n\nAim I: To demonstrate the effectiveness of the Safe and Sound Protocol (SSP) on improvement of social and regulation behaviors in individuals with PWS.\n\nAim 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Child participants must meet criteria for Prader-Willi Syndrome (per parent membership in Prader-Willi Parent Support Group).\n2. Child participants must be between ages 3-17 years. Parent must be 18 years or older.\n3. Child participants must have normal hearing (confirmed via parental report on Qualtrics questionnaire)\n\nExclusion Criteria:\n\n1\\) Child participants who are hearing-impaired (without correction)'}, 'identificationModule': {'nctId': 'NCT03871751', 'briefTitle': 'Home-based SSP on Individuals With PWS', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Evaluating the Effectiveness of Home-based SSP on Individuals With PWS', 'orgStudyIdInfo': {'id': '1807300643'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Safe and Sound Protocol', 'description': '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.', 'interventionNames': ['Behavioral: Safe and Sound Protocol']}], 'interventions': [{'name': 'Safe and Sound Protocol', 'type': 'BEHAVIORAL', 'otherNames': ['Listening Project Protocol'], 'description': '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.', 'armGroupLabels': ['Safe and Sound Protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80014', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Integrated Listening Systems', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Jacek Kolacz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University/Kinsey Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Integrated Listening Systems', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Research Scientist', 'investigatorFullName': 'Jacek Kolacz', 'investigatorAffiliation': 'Indiana University'}}}}