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Read research studies on the
Focus System

Read research studies on the
Safe & Sound Protocol (SSP)


All Research & Supporting Data
Download an overview of all research & supporting data


A Pilot Study of Integrated Listening Systems for Children with Sensory Processing Problems

Sarah A. Schoen, PhD, OTR, Lucy J. Miller, PhD, OTR, and Jillian Sullivan, PhD
Journal of Occupational Therapy: Schools and Early Intervention, 8: 1-21 2015
Summary: This study explores the effects of iLs on individualized parent goals for children with sensory processing impairments.  The 40-session iLs program was implemented at home and in clinic over a 3-month period. Important and clinically meaningful gains were achieved by all participants in both home and educationally-related goals.  Individualized goal achievement was supported by gains in standardized measures of behavior and adaptive functioning. Changes in physiological arousal (measured by EDA – electrodermal activity) suggest the iLs program is impacting underlying regulation mechanisms that may be contributing to the observed behavioral changes.  Behavioral changes included increased relaxation, fewer meltdowns and a generally calmer disposition for participants whose arousal decreased.

K-2 Literacy Study

J. Anne Calhoon, Ph. D. Educational Psychology, University of New Mexico
Summary: A controlled study involving 64 K-2 at-risk students was conducted by U of New Mexico researcher Anne Calhoon, Ph.D. Students participated in the Alpha Program,* a program combining iLs with art therapy. The average improvement in reading over the 3-month intervention was 2 years.  “Taken as a whole, this analysis indicates that the students in the experimental group have improved in all categories associated with reading. This improved achievement is significantly greater (more meaningful) than the improvements of the control group peers. Overall the picture presented of the students in ALPHA is one that shows immense growth in cognitive, academic, and psychological areas.”

An Investigation to Evaluate the Benefits of the Integrated Listening Systems (iLs) in Primary/Early Elementary Classrooms (K-3): The Case of Valley View Academy in Northern California

Jeannie Dubitsky, Ed. D., University of California, Davis, 2014
Summary: Ten students were measured over an academic year of using iLs while at school. Students showed improvement in all areas evaluated – physical, academic, social and emotional development – after experiencing the iLs program.

Auditory Processing Disorder data from Therapeeds Center, Fort Lauderdale, FL

Julia Harper, PhD, OTR/L and Aimee Levine Weiner, Aud; published in Advance OT Magazine
Summary: Therapeeds, a private clinic in Ft. Lauderdale, Florida, gathered data on 29 children diagnosed with APD (auditory processing disorder) who completed the Therapeeds’ H.O.P.E. sensory motor program combined with iLs. Among the pre- and post-program results are the following:

  • Vestibular function: Pre-testing indicated 0 of the 29 children had intact vestibular processing skills measured by the PrN and functional skills. Post-testing showed all 29 in normal range.
  • Auditory Processing Skills: Post-intervention, 22 of the 29 children had auditory processing skills that were completely within normal limits in every area.
  • Medications: Seven of 29 children began this therapy on medication for attention-related concerns. By the end of the program, the medications for all 7 had all been discontinued.
  • ABR Binaural Summation: Pre-intervention ABR tests showed all 29 children had little difference between listening with one ear and listening with both ears (binaural summation). Post-intervention, all 29 tested in the normal range.

School Pilot Study

Denver Area Schools
Summary: A variety of normed, standardized tests were used to assess 20 children with learning difficulties before and after iLs programs. The report includes each child’s pre- and post-program test scores as well as teacher and parent comments. Teachers involved in the program reported “significant improvement” in 19 of the 20 children. The criteria for “significant improvement” include at least one of the following: being transitioned from special education to regular education, having an IEP removed or overcoming a substantial behavioral challenge.
Description: Data on the efficacy of iLs in school programs.

iLs Home Program Autism Study

Theresa May Benson, PhD, OTR/L
Summary: This study on the effect of the iLs home program on 18 children diagnosed with autism was conducted by Dr. Teresa May Benson of The Spiral Foundation, a non-profit research organization. The purpose of the multi‐site intervention study was to examine the effectiveness of the iLs Focus home program with 18 children, ages 4 to 8, diagnosed with Autism Spectrum Disorder (ASD). Results found significant gains across multiple subjective and objective outcome measures in the following areas: social skills, emotional regulation, number and severity of autistic behaviors, and overall functional adaptive behavior skills.

Survey of iLs Professionals

Spiral Foundation, Boston, MA
Summary: Survey reviewing therapists’ experience using iLs with over 1300 children on the autism spectrum. The survey asked the question: In what areas is iLs effective? Results are in 24 outcome categories.

Cochlear Implant Study

Ann Brownstone, MS, OTR/L, SWC, Jennifer Aguilar, MS, CCC-SLP, Lisa Marcacci, MS, Aud.
Summary: This study was conducted at the Jean Weingarten Peninsula Oral School for the Deaf, Redwood City, CA by Ann Brownstone, MS, OTR/L, SWC, Jennifer Aguilar, MS, CCC-SLP, and Lisa Marcacci, MS, Aud.  It examines the application of iLs with children wearing cochlear implants and also provides a general reference guide for using iLs in conjunction with cochlear implants and other hearing devices.


Respiratory Sinus Arrhythmia And Auditory Processing In Autism: Modifiable Deficits Of An Integrated Social Engagement System?

Stephen W. Porges, Matthew Macallaio, Shannon D. Stanfill, Kimberly McCue, Gregory F. Lewis, Emily R. Harden, Mika Handelman, John Denver, Olga V. Bazhenova, and Keri J. Heilman 
International Journal of Psychophysiology, 2013 Jun; 88(3): 261-270
In this peer-reviewed study, higher functioning individuals with ASD were tested using an early version of the SSP.  The study showed that auditory processing and state regulation improved following the intervention.

Reducing Hypersensitivities In Autistic Spectrum Disorder: Preliminary Findings Evaluating The Listening Project Protocol (A Precursor To The Safe And Sound Protocol)

Stephen W. Porges, Olga V. Bazhenova, Elgiz Bal, Nancy Carlson, Yevgeniya Sorokin, Keri J. Heilman, Edwin H. Cook, and Gregory F. Lewis
Frontiers in Pediatrics, 2014; 2:80
In a second peer-reviewed study, children with Autism Spectrum Disorder (ASD) who used an early version of the SSP experienced significant improvements in emotional organization, listening, spontaneous speech and hearing sensitivities.

The Listening Project: Tuning Into Change

Stephen W. Porges, PhD, University of North Carolina, Chapel Hill

Summary: A research project funded by the Australian Childhood Foundation (ACF) will be conducted in Australian facilities of the ACF to evaluate the effectiveness of the Safe & Sound Protocol (SSP) in children with a trauma history. The SSP is designed as a “neural exercise” to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. The SSP 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 SSP and will use objective measures to evaluate changes in acoustic transfer function of the middle ears structures, auditory processing skills, physiological state regulation, and sensory symptoms.

The Listening Project at the ADD Centre and Biofeedback Institute of Toronto

Stephen W. Porges, University of North Carolina, Chapel Hill

Summary: A research project will be conducted at the ADD (“Attention Deficit Disorder”) Centre and Biofeedback Institute of Toronto to evaluate the feasibility of the Safe & Sound Protocol (SSP) intervention in individuals with difficulties with autonomic and/or behavioral regulation. The SSP is designed as a “neural exercise” to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. These improvements should translate into increase feelings of safety and calmness, thereby promoting improvement in social behavior.

Home-based SSP on Individuals With PWS

Stephen W. Porges, University of North Carolina, Chapel Hill

Summary: To assess the effects of the SSP on improvement of social and regulation behaviors in individuals with Prader Willi Syndrome. In addition, a new methodology for collecting and evaluating vocal samples for analyses of prosody will be assessed.

Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory

Stephen W. Porges, Indiana University and University of North Carolina, Chapel Hill

Summary: To demonstrate that children with Prader-Willi Syndrome (PWS) have atypical regulation of the Social Engagement System (SES). We hypothesize these effects will be manifested by dampened vagal regulation of the heart (low parasympathetic tone); poor middle ear muscle regulation resulting in auditory hypersensitivities and poor auditory processing; lack of voice intonation (prosody), and difficulties in accurately detecting the emotions of others.

To demonstrate the effectiveness of the Safe & Sound Protocol (SSP) in decreasing the atypical features of the SES in adolescents with PWS. We hypothesize that individuals who complete the SSP will have improved vagal regulation of the heart, improved middle ear muscle regulation, increased voice intonation and improved ability to accurately detect the emotions of others.

Examining the Effects of Processed Music on Chronic Pain

Stephen W. Porges, Indiana University and University of North Carolina, Chapel Hill

Summary: To examine whether the Safe & Sound Protocol (SSP), a non-invasive audio intervention, can be effective for reducing chronic pain in a sample of older adults and whether increased regulation via the autonomic nervous system accounts for the decrease in pain if the intervention is successful.

The Effect of the SSP on the Regulation of Hypersensitivity in ASD

Sonja Heinrich (autismus-dialog), Michel Ackermann (Berliner Institut für Familientherapie), Prof.Hristo Kyuchukov (Univ.of Silesia Katowice), Prof.William New (Beloit College)

Summary: This is the first study to assess the effects of the SSP on visual, tactile, digestive, and selective eating domains as well as the first ASD-specific study of the SSP in Germany.


columbiaComparative Effectiveness of Three Occupational Therapy Sleep Interventions: A Randomized Controlled Study

Sharon A. Gutman, PhD, OTR, FAOTA, Associate Professor, Columbia University Medical Center

Summary: Conducted by Dr. Sharon Gutman at Columbia University Medical Center, this randomized, controlled study of 29 adults with light sleep difficulties compared three non-pharmacological sleep interventions: the Dreampad™ pillow with Intrasound Technology, an audio breathing program called iRest™, and sleep hygiene (sleep improvement behavior such as reducing food, alcohol and screen time before bed). The most statistically significant results of the study were the reduction in night time awakenings experienced by Dreampad users. Waking during the night is the number one symptom reported by those with stress related sleep problems as well as the number one problem reported by the study participants.

A Sleep Intervention for Children with Autism

Sarah Schoen, PhD, OTR, Assistant Research Director, SPD Foundation
Summary: The aim of this study was to examine the immediate, short-term effects of the Dreampad on the sleep behaviors of children with Autism Spectrum Disorder (ASD). In addition, this study examined the effects of changes in sleep patterns on parent and family measures of stress and quality of life.
“Improvements were noted in sleep initiation, duration of sleep, reduction in night waking and improved daytime behavior. All 15 children showed a decrease in sleep problems as noted in response to the sleep diary or the CSHQ. Similarly all 15 families had improved scores on the Pediatric Quality of Life Questionnaire, some of which persisted beyond the time they were actively using the Dreampad. Changes were most notable in emotional, social and school functioning. All of the parents reported a positive reaction to using the Dreampad and were interested in continuing its use. Many said their children were going to bed/sleep more quickly, sleeping more soundly, waking up more easily and generally seemed more relaxed.”

Preliminary Study: The Effect of the Dreampad on Children with ADHD and Sleep- Related Difficulties

The Hallowell Center, New York, NY
Summary: Therapists at the Hallowell Center in New York City conducted a pilot study on the effect of the Dreampad on 8 children diagnosed with ADHD. Measures included The Child’s Sleep Habits Questionnaire (CSHQ) and a sleep diary. The most notable changes were in sleep behavior: waking during the night and morning wake-up. All but one child no longer showed any problems waking during the night. All but two children showed improvement in sleep behavior and morning wake-up.

iLs Dreampad Heart Rate Variability (HRV) Study

Kelly L. Olson, Ph.D., Director, Clinical Research and Development, SleepImage
Summary: This study measures the effect of the Dreampad on relaxation using heart rate variability (HRV); HRV is widely considered the most authoritative reference for the Parasympathetic Nervous System, which governs our relaxation response.

Measuring the Effect of the iLs Dreampad with Ten Veterans Diagnosed with Post-Traumatic Stress Disorder (PTSD)

Jan C. Nelson, OTR, MA
“This pilot project was designed as a first step in determining the efficacy of the Integrated Listening Systems’ (iLs) Dreampad™ in influencing pain reduction and sleep behavior in military veterans diagnosed with PTSD.  Subjects did not see outcomes in the area of pain reduction; however, significant results were seen with falling asleep, staying asleep and reducing nightmares and symptoms associated with PTSD.”

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