Sensory DisordersNCT05249270
Online Parent-Report Evaluation of the Effects of Processed Music
An observational study of Sensory Disorders and Sensory Processing Disorder, run by Indiana University at 1 site in United States.
Trial summary
The study aims to examine effectiveness of the Safe and Sound Protocol (SSP) on sensory, digestive, and eating behaviors in children currently receiving therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensory Disorders, Sensory Processing Disorder, Autism Spectrum Disorder
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2020to 28 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Parents or legal guardians of children who are receiving the Safe and Sound Protocol at Children's Therapy of Woodinville (in Woodinville, WA)
Who may be able to join
- Parent or legal guardian of child who is receiving the Safe and Sound Protocol at Children's Therapy of Woodinville (in Woodinville, WA)
- Parent must be 18 years or older
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Therapy of Woodinville
Woodinville, Washington, 98072
About this study
The study aims to examine effectiveness of the Safe and Sound Protocol (SSP) on sensory, digestive, and eating behaviors in children currently receiving therapy.
Read the detailed description
The SSP consists of listening to a computer altered sequence of vocal music that has been processed to "exercise" the neural regulation of the middle ear muscles. Low and high frequencies are dynamically filtered and presented monaurally to both ears. The intervention stimuli are delivered through headphones or speakers. The protocol consists of 60 minutes of listening on five sequential days and is delivered via a music player device in a quiet room without major distractors.
For this study, parents or legal guardians of children already enrolled to complete the SSP intervention at Children's Therapy of Woodinville will complete a series of surveys. The SSP is used as a component of therapy across multiple diagnostic categories including autism spectrum disorders and sensory processing disorder. No specific diagnoses will be targeted in this design. Parents will be recruited for the study if their child is already enrolled to receive the therapy. Participating parents will be asked to complete online questionnaires using a survey link at three intervals: before the start of therapy, one week after completion, and 1 month after completion.
- Conditions
- Sensory Disorders, Sensory Processing Disorder, Autism Spectrum Disorder, Eating Disorders, Gastro-Intestinal Disorder, Swallowing Disorder
- Medical subject headings
- Sensation Disorders, Autism Spectrum Disorder, Feeding and Eating Disorders, Digestive System Diseases, Deglutition Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Safe and Sound Protocol Participants | Parents of children receiving the Safe and Sound Protocol (a clinical auditory therapy provided outside of the study) will complete questionnaires to assess sensory behaviors prior to therapy initiation (baseline), 1 week after therapy conclusion, and 4 weeks after therapy conclusion. The SSP typically consists of 1 hour of listening per day, for 5 consecutive days. If modifications of the typical dosage are implemented due to client needs, they will be documented by parents in the 1 week post therapy questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory sensitivities
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
Measured: Change from baseline to 1 and 4 week post assessment
Secondary outcomes (3)
Selective eating
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
Measured: Change from baseline to 1 and 4 week post assessment
Ingestive problems
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
Measured: Change from baseline to 1 and 4 week post assessment
Digestive problems
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
Measured: Change from baseline to 1 and 4 week post assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start22 Mar 2020
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Why it stopped: Inadequate resources ot complete data collection during COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sensory DisordersStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Therapy of Woodinville
- Responsible party
- Principal investigator, Jacek Kolacz, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249270
- Sponsor's protocol ID
- 1912463776
- Status last verified
- Aug 2024
- First submitted
- 19 Mar 2021
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25136545Porges SW, Macellaio M, Stanfill SD, McCue K, Lewis GF, Harden ER, Handelman M, Denver J, Bazhenova OV, Heilman KJ. Respiratory sinus arrhythmia and auditory processing in autism: modifiable deficits of an integrated social engagement system? Int J Psychophysiol. 2013 Jun;88(3):261-70. doi: 10.1016/j.ijpsycho.2012.11.009. Epub 2012 Nov 29.
PubMed 23201146
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Parent-Report Evaluation of the Effects of Processed Music
- ClinicalTrials.gov ID
- NCT05249270
- Acronym / sponsor ID
- 1912463776
- Conditions
- Sensory Disorders, Sensory Processing Disorder, Autism Spectrum Disorder, Eating Disorders, Gastro-Intestinal Disorder, Swallowing Disorder
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inadequate resources ot complete data collection during COVID pandemic
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Children's Therapy of Woodinville
- Study start
- 22 Mar 2020 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to examine effectiveness of the Safe and Sound Protocol (SSP) on sensory, digestive, and eating behaviors in children currently receiving therapy.
Detailed description
The SSP consists of listening to a computer altered sequence of vocal music that has been processed to "exercise" the neural regulation of the middle ear muscles. Low and high frequencies are dynamically filtered and presented monaurally to both ears. The intervention stimuli are delivered through headphones or speakers. The protocol consists of 60 minutes of listening on five sequential days and is delivered via a music player device in a quiet room without major distractors.
For this study, parents or legal guardians of children already enrolled to complete the SSP intervention at Children's Therapy of Woodinville will complete a series of surveys. The SSP is used as a component of therapy across multiple diagnostic categories including autism spectrum disorders and sensory processing disorder. No specific diagnoses will be targeted in this design. Parents will be recruited for the study if their child is already enrolled to receive the therapy. Participating parents will be asked to complete online questionnaires using a survey link at three intervals: before the start of therapy, one week after completion, and 1 month after completion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safe and Sound Protocol Participants | – | –Parents of children receiving the Safe and Sound Protocol (a clinical auditory therapy provided outside of the study) will complete questionnaires to assess sensory behaviors prior to therapy initiation (baseline), 1 week after therapy conclusion, and 4 weeks after therapy conclusion. The SSP typically consists of 1 hour of listening per day, for 5 consecutive days. If modifications of the typical dosage are implemented due to client needs, they will be documented by parents in the 1 week post therapy questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Parents or legal guardians of children who are receiving the Safe and Sound Protocol at Children's Therapy of Woodinville (in Woodinville, WA)
Key inclusion criteria (2 listed)
- Parent or legal guardian of child who is receiving the Safe and Sound Protocol at Children's Therapy of Woodinville (in Woodinville, WA)
- Parent must be 18 years or older
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensory sensitivities
Time frame: Change from baseline to 1 and 4 week post assessment
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
3 secondary outcomes
Selective eating
Time frame: Change from baseline to 1 and 4 week post assessment
Ingestive problems
Time frame: Change from baseline to 1 and 4 week post assessment
Digestive problems
Time frame: Change from baseline to 1 and 4 week post assessment
Results and safety
The study was stopped early (reason given: Inadequate resources ot complete data collection during COVID pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 25136545Porges 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.
- Background: PubMed 23201146Porges SW, Macellaio M, Stanfill SD, McCue K, Lewis GF, Harden ER, Handelman M, Denver J, Bazhenova OV, Heilman KJ. Respiratory sinus arrhythmia and auditory processing in autism: modifiable deficits of an integrated social engagement system? Int J Psychophysiol. 2013 Jun;88(3):261-70. doi: 10.1016/j.ijpsycho.2012.11.009. Epub 2012 Nov 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensory Disorders and Sensory Processing Disorder, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate resources ot complete data collection during COVID pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory sensitivities (time frame: Change from baseline to 1 and 4 week post assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05249270, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.