Prader-Willi SyndromeNCT03871751
Home-based SSP on Individuals With PWS
A study testing Safe and Sound Protocol in people with Prader-Willi Syndrome, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- Safe and Sound Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2019to 16 Dec 2019
- Phase
- Interventional
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child participants must meet criteria for Prader-Willi Syndrome (per parent membership in Prader-Willi Parent Support Group).
- Child participants must be between ages 3-17 years. Parent must be 18 years or older.
- Child participants must have normal hearing (confirmed via parental report on Qualtrics questionnaire)
Who cannot join
- 1) Child participants who are hearing-impaired (without correction)
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrated Listening Systems
Aurora, Colorado, 80014
About this study
Official title: Evaluating the Effectiveness of Home-based SSP on Individuals With PWS
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.
Individuals 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").
Read more
Specific Aims:
Aim I: To demonstrate the effectiveness of the Safe and Sound Protocol (SSP) on improvement of social and regulation behaviors in individuals with PWS.
Aim 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.
- Conditions
- Prader-Willi Syndrome
- Being tested
- Safe and Sound Protocol
- Keywords
- Polyvagal Theory, Social Behavior, Hyperacusis, Prosody, Auditory intervention
- Medical subject headings
- Prader-Willi Syndrome, Social Behavior, Hyperacusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe and Sound ProtocolBehavioural
Also called Listening Project Protocol
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.
| Study group | Role | What they receive |
|---|---|---|
| Safe and Sound Protocol | Experimental | 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. Receives: Behavioral: Safe and Sound Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in sensory sensitivities at 1 week
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
Measured: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)
Secondary outcomes (4)
Change from baseline in disruptive behavior at 1 week
Developmental Behavior Checklist (DBC2) (questionnaire)
Measured: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)
Change from baseline in social behavior at 1 week
Safe and Sound Protocol (SSP) Parent Questionnaire
Measured: post-intervention (within 1 week after intervention)
Change from baseline in Foundational Abilities (balance, gross & fine motor control, sensory, social/emotional, auditory/language and attention/organization and sleep) at 1 week
Measure of Foundational Abilities (MFA) questionnaire
Measured: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)
Change from baseline in prosody at 1 week
Prosody assessment of recorded speech
Measured: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start8 Apr 2019
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Why it stopped: Insufficient resources to complete study as planned
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 Prader-Willi SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the auditory intervention.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Integrated Listening Systems
- Responsible party
- Principal investigator, Jacek Kolacz, Indiana University
- Investigators
- Jacek Kolacz, PhD, Principal investigator, Indiana University/Kinsey Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871751
- Sponsor's protocol ID
- 1807300643
- Status last verified
- Feb 2022
- First submitted
- 25 Feb 2019
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11587772Porges 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 25136545
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Home-based SSP on Individuals With PWS
- ClinicalTrials.gov ID
- NCT03871751
- Acronym / sponsor ID
- 1807300643
- Conditions
- Prader-Willi Syndrome
- Keywords
- Polyvagal Theory, Social Behavior, Hyperacusis, Prosody, Auditory intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient resources to complete study as planned
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Integrated Listening Systems
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 12 Mar 2019 (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 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.
Individuals 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").
Specific Aims:
Aim I: To demonstrate the effectiveness of the Safe and Sound Protocol (SSP) on improvement of social and regulation behaviors in individuals with PWS.
Aim 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the auditory intervention.
| Arm | Type | Receives |
|---|---|---|
| Safe and Sound Protocol | Experimental | Behavioral: Safe and Sound ProtocolAll 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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child participants must meet criteria for Prader-Willi Syndrome (per parent membership in Prader-Willi Parent Support Group).
- Child participants must be between ages 3-17 years. Parent must be 18 years or older.
- Child participants must have normal hearing (confirmed via parental report on Qualtrics questionnaire)
Key exclusion criteria (1 listed)
- 1) Child participants who are hearing-impaired (without correction)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe and Sound ProtocolAlso: Listening Project ProtocolThe 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. | Behavioural | Safe and Sound Protocol |
Primary outcome
Change from baseline in sensory sensitivities at 1 week
Time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)
Brain-Body Center Sensory Scales (BBC Sensory Scales) (parental questionnaire)
4 secondary outcomes
Change from baseline in disruptive behavior at 1 week
Time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)
Change from baseline in social behavior at 1 week
Time frame: post-intervention (within 1 week after intervention)
Change from baseline in Foundational Abilities (balance, gross & fine motor control, sensory, social/emotional, auditory/language and attention/organization and sleep) at 1 week
Time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)
Change from baseline in prosody at 1 week
Time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)
Results and safety
The study was stopped early (reason given: Insufficient resources to complete study as planned). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Background: PubMed 11587772Porges 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.
- 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.
- 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.
Jacek Kolacz, PhD principal investigator
Indiana University/Kinsey Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe and Sound Protocol in people with Prader-Willi Syndrome, 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 3 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 7 Mar 2022. 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: Insufficient resources to complete study as planned). 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?
Change from baseline in sensory sensitivities at 1 week (time frame: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention)). 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 NCT03871751, 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 7 Mar 2022.