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The Listening Project at Reiss-Davis/Vista Del Mar Child and Family Services

The Listening Project at Reiss-Davis/Vista Del Mar Child and Family Services

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02398422
Enrollment
15
Registered
2015-03-25
Start date
2015-10-31
Completion date
2018-12-31
Last updated
2021-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auditory Perceptual Disorders, Stress Disorder

Keywords

Autonomic nervous system, Auditory processing disorder, Social behavior

Brief summary

A research project funded by the Reiss-Davis Child Study Center of Vista Del Mar (RDCSC/VDM) will be conducted on the Vista Del Mar campus of the RDCSC/VDM to evaluate the effectiveness of the Listening Project Protocol (LPP) in children who have difficulties with autonomic and behavior regulation in the classroom. The LPP is designed as a neural exercise to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. The LPP uses acoustic stimulation to exercise the neural regulation of the middle ear structures to rehabilitate and to normalize the acoustic transfer function of the middle ear structures. The current study is being conducted to evaluate efficacy and feasibility of the LPP with emotionally disturbed and learning challenged young people and will use objective measures to evaluate changes in acoustic transfer function of the middle ears structures, auditory processing skills, physiological state regulation, sensory symptoms, and academic pre and post testing.

Interventions

The filtered-music 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. The non-filtered music intervention will consist of the same music as the filtered-music intervention.

Sponsors

Reiss-Davis Child Study Center of Vista Del Mar
CollaboratorUNKNOWN
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* children must be between ages 6-17 years * children must be able to read/speak in English. Parents must be able to read/speak in either English or Spanish * children must be patients, students and/or residents at Reiss-Davis/Vista del Mar

Exclusion criteria

* children who wear a hearing device * children with a history of heart disease * children who are currently being treated for a seizure disorder * children who are non-verbal

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in auditory hypersensitivity at 1 week, and at 2 monthspre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 2 months post-interventionBrain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)

Secondary

MeasureTime frameDescription
Change from baseline in state regulation at 1 week, and at 2 monthspre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-interventionheart rate, heart period, high-frequency heart rate variability/respiratory sinus arrhythmia
Change from baseline in auditory processing at 1 week, and at 2 monthspre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-interventionfiltered words, competing words subscales of SCAN
Change from baseline in social behavior at 1 week, and at 2 monthspost-intervention (within 1 week after the intervention), 2 months post-interventionListening Project Parent Questionnaire
Change from baseline in middle ear transfer function at 1 week, and at 2 monthspost-intervention (within 1 week after the intervention), 2 months post-interventionMiddle Ear Sound Absorption System (MESAS)

Other

MeasureTime frameDescription
Change from baseline in classroom behavior at 1 week, and at 2 monthspre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-interventionTeacher-completed ASEBA
Change from baseline in home behavior at 1 week, and at 2 monthspre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 2 months post-interventionCaregiver-completed ASEBA

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026