Prader-Willi SyndromeNCT03101826
Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory
A study testing Listening Project 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 13 to 25 years
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- Listening Project Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 8 Mar 2023
- 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 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants must be current residents at Latham Centers (LC) School in Brewster MA
- Participants must meet criteria for Prader-Willi Syndrome
- Participants must be between ages 13 - 25 years
- Participants must have normal hearing
- Participants must have normal vision (or corrected vision)
Who cannot join
- Individuals with current (or a history of) heart disease
- Individuals who are hearing-impaired
- Individuals who are being treated for seizure disorder
- Individuals who do not read/speak English
- Individuals who are sight-impaired without correction
Trial locations and contacts
1 site in 1 country.
United States1 site
Latham Centers School
Brewster, Massachusetts, 02631
About this study
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. We propose to confirm that several features of the behavioral phenotype of PWS may be explained within the context of a dysfunctional SES (Specific Aim I), which may be partially rehabilitated via an intervention designed as a 'neural exercise' of the SES (Specific Aim II).
Read more
Specific Aims:
Aim I: To demonstrate that children with PWS have atypical regulation of the 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.
Aim II: To demonstrate the effectiveness of the Listening Project Protocol (LPP) in decreasing the atypical features of the SES in adolescents with PWS. We hypothesize that individuals who complete the LPP 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.
- Conditions
- Prader-Willi Syndrome
- Being tested
- Listening Project Protocol
- Keywords
- Polyvagal Theory, Respiratory Sinus Arrhythmia, Heart rate, Social Behavior, Arginine Vasopressin, Dichotic Listening Tests, Oxytocin, Hyperacusis, Affect, Auditory perception, Sound spectrography
- Medical subject headings
- Prader-Willi Syndrome, Arrhythmia, Sinus, Social Behavior, Diabetes Insipidus, Hyperacusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening Project ProtocolBehavioural
Also called Safe and Sound Protocol
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.
| Study group | Role | What they receive |
|---|---|---|
| Filtered Music Intervention | Experimental | All participants will participate in pre-intervention assessments (6 months, 1 week prior) and post-intervention assessments (1 week, 1 month post). The Filtered Music Intervention (i.e., Listening Project Protocol) will last for 1 hour per day, for 5 consecutive days. Receives: Behavioral: Listening Project Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Intervention on Autonomic regulation
Respiratory sinus arrhythmia (RSA)
Measured: Change from 1 week pre-intervention RSA to 1 month post-intervention
Secondary outcomes (11)
Effect of Intervention on Heart period
heart period
Measured: Change from 1 week pre-intervention heart period to 1 month post-intervention
Effect of Intervention on Auditory processing
Filtered Words subtest of SCAN
Measured: Change from 1 week pre-intervention Filtered Words to 1 month post-intervention
Effect of Intervention on Auditory processing
Competing Words subtest of SCAN
Measured: Change from 1 week pre-intervention Competing Words to 1 month post-intervention
Effect of Intervention on Sensory Sensitivities
BBC Sensory Scales (questionnaire)
Measured: Change from 1 week pre-intervention BBC Sensory Scales to 1 month post-intervention
Effect of Intervention on Latency to Affect recognition
Dynamic Affect Recognition Evaluation (DARE) - latency
Measured: Change from 1 week pre-intervention DARE (latency) to 1 month post-intervention
Effect of Intervention on Accuracy of Affect recognition
Dynamic Affect Recognition Evaluation (DARE) - accuracy
Measured: Change from 1 week pre-intervention DARE (accuracy) to 1 month post-intervention
Effect of Intervention on Prosody
Analyses of vocal recordings
Measured: Change from 1 week pre-intervention Prosody to 1 month post-intervention
Effect of Intervention on Disruptive Behavior
Developmental Behavior Checklist (DBC) (questionnaire)
Measured: Change from 1 week pre-intervention DBC to 1 month post-intervention
Effect of Intervention on Social behavior
Listening Project Parent (LPP) Questionnaire
Measured: Change from 1 week post-intervention LPP to 1 month post-intervention
Effect of Intervention on Oxytocin
oxytocin levels derived from salivary sample
Measured: Change from 1 week pre-intervention oxytocin to 1 month post-intervention
Effect of Intervention on Vasopressin
vasopressin levels derived from salivary sample
Measured: Change from 1 week pre-intervention vasopressin to 1 month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start1 Nov 2017
- Primary completion8 Mar 2023
- Study completion8 Mar 2023
Why it stopped: Insufficient resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prader-Willi SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the active (filtered music) intervention.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Latham Centers
- Responsible party
- Principal investigator, Stephen Porges, Indiana University
- Investigators
- Stephen W Porges, PhD, Principal investigator, Indiana University/Kinsey Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101826
- Sponsor's protocol ID
- 1609337519
- Status last verified
- Mar 2023
- First submitted
- 23 Mar 2017
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bal E, Harden E, Lamb D, Van Hecke AV, Denver JW, Porges SW. Emotion recognition in children with autism spectrum disorders: relations to eye gaze and autonomic state. J Autism Dev Disord. 2010 Mar;40(3):358-70. doi: 10.1007/s10803-009-0884-3.
PubMed 19885725Borg E, Counter SA. The middle-ear muscles. Sci Am. 1989 Aug;261(2):74-80. doi: 10.1038/scientificamerican0889-74. No abstract available.
PubMed 2667133Lewis GF, Furman SA, McCool MF, Porges SW. Statistical strategies to quantify respiratory sinus arrhythmia: are commonly used metrics equivalent? Biol Psychol. 2012 Feb;89(2):349-64. doi: 10.1016/j.biopsycho.2011.11.009. Epub 2011 Dec 3.
PubMed 22138367Porges 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, 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 23201146Porges 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 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Social Engagement System in Prader-Willi Syndrome: Insights From the Polyvagal Theory
- ClinicalTrials.gov ID
- NCT03101826
- Acronym / sponsor ID
- 1609337519
- Conditions
- Prader-Willi Syndrome
- Keywords
- Polyvagal Theory, Respiratory Sinus Arrhythmia, Heart rate, Social Behavior, Arginine Vasopressin, Dichotic Listening Tests, Oxytocin, Hyperacusis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient resources
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Latham Centers
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 5 Apr 2017 (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. We propose to confirm that several features of the behavioral phenotype of PWS may be explained within the context of a dysfunctional SES (Specific Aim I), which may be partially rehabilitated via an intervention designed as a 'neural exercise' of the SES (Specific Aim II).
Specific Aims:
Aim I: To demonstrate that children with PWS have atypical regulation of the 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.
Aim II: To demonstrate the effectiveness of the Listening Project Protocol (LPP) in decreasing the atypical features of the SES in adolescents with PWS. We hypothesize that individuals who complete the LPP 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.
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 active (filtered music) intervention.
| Arm | Type | Receives |
|---|---|---|
| Filtered Music Intervention | Experimental | Behavioral: Listening Project ProtocolAll participants will participate in pre-intervention assessments (6 months, 1 week prior) and post-intervention assessments (1 week, 1 month post). The Filtered Music Intervention (i.e., Listening Project Protocol) will last for 1 hour per day, for 5 consecutive days. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Participants must be current residents at Latham Centers (LC) School in Brewster MA
- Participants must meet criteria for Prader-Willi Syndrome
- Participants must be between ages 13 - 25 years
- Participants must have normal hearing
- Participants must have normal vision (or corrected vision)
Key exclusion criteria (5 listed)
- Individuals with current (or a history of) heart disease
- Individuals who are hearing-impaired
- Individuals who are being treated for seizure disorder
- Individuals who do not read/speak English
- Individuals who are sight-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 |
|---|---|---|
| Listening Project ProtocolAlso: Safe and Sound ProtocolThe 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. | Behavioural | Filtered Music Intervention |
Primary outcome
Effect of Intervention on Autonomic regulation
Time frame: Change from 1 week pre-intervention RSA to 1 month post-intervention
Respiratory sinus arrhythmia (RSA)
11 secondary outcomes
Effect of Intervention on Heart period
Time frame: Change from 1 week pre-intervention heart period to 1 month post-intervention
Effect of Intervention on Auditory processing
Time frame: Change from 1 week pre-intervention Filtered Words to 1 month post-intervention
Effect of Intervention on Auditory processing
Time frame: Change from 1 week pre-intervention Competing Words to 1 month post-intervention
Effect of Intervention on Sensory Sensitivities
Time frame: Change from 1 week pre-intervention BBC Sensory Scales to 1 month post-intervention
Effect of Intervention on Latency to Affect recognition
Time frame: Change from 1 week pre-intervention DARE (latency) to 1 month post-intervention
Effect of Intervention on Accuracy of Affect recognition
Time frame: Change from 1 week pre-intervention DARE (accuracy) to 1 month post-intervention
Effect of Intervention on Prosody
Time frame: Change from 1 week pre-intervention Prosody to 1 month post-intervention
Effect of Intervention on Disruptive Behavior
Time frame: Change from 1 week pre-intervention DBC to 1 month post-intervention
Effect of Intervention on Social behavior
Time frame: Change from 1 week post-intervention LPP to 1 month post-intervention
Effect of Intervention on Oxytocin
Time frame: Change from 1 week pre-intervention oxytocin to 1 month post-intervention
Effect of Intervention on Vasopressin
Time frame: Change from 1 week pre-intervention vasopressin to 1 month post-intervention
Results and safety
The study was stopped early (reason given: Insufficient resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Background: PubMed 19885725Bal E, Harden E, Lamb D, Van Hecke AV, Denver JW, Porges SW. Emotion recognition in children with autism spectrum disorders: relations to eye gaze and autonomic state. J Autism Dev Disord. 2010 Mar;40(3):358-70. doi: 10.1007/s10803-009-0884-3.
- Background: PubMed 2667133Borg E, Counter SA. The middle-ear muscles. Sci Am. 1989 Aug;261(2):74-80. doi: 10.1038/scientificamerican0889-74. No abstract available.
- Background: PubMed 22138367Lewis GF, Furman SA, McCool MF, Porges SW. Statistical strategies to quantify respiratory sinus arrhythmia: are commonly used metrics equivalent? Biol Psychol. 2012 Feb;89(2):349-64. doi: 10.1016/j.biopsycho.2011.11.009. Epub 2011 Dec 3.
- 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 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.
- 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
Related trials for Prader-Willi Syndrome
RecruitingPhase 2
A Study of CSTI-500 in Patients With Prader-Willi Syndrome
Prader-Willi Syndrome
Recruiting
Cerebellar TMS and Satiety in Prader-Willi Syndrome
Prader-Willi Syndrome
Enrolling by invitationObservational study
Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome
Prader-Willi Syndrome
Active, not recruitingPhase 1/2
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
Hypothalamic Obesity, Prader-Willi Syndrome
Active, not recruiting
Impact of Bright Light Therapy on Prader-Willi Syndrome
Prader-Willi Syndrome, Excessive Daytime Sleepiness
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.
Stephen W Porges, 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 Listening Project 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 5 inclusion and 5 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 3 Apr 2023. 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). 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?
Effect of Intervention on Autonomic regulation (time frame: Change from 1 week pre-intervention RSA to 1 month post-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 NCT03101826, which also lists 6 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 3 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.