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Listening Project Protocol for Stress Disorders
N/A
Waitlist Available
Led By Keri J Heilman, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-intervention (within 1 week before intervention), immediate post-intervention (within 1 week after intervention), 1 month post-intervention
Awards & highlights
Study Summary
This trial will study the feasibility of the Listening Project Protocol intervention in individuals with difficulties with autonomic and/or behavioral regulation.
Who is the study for?
This trial is for English-speaking males and females aged 7-55 who are current or past clients at the ADD Centre & Biofeedback Institute of Toronto. It's not suitable for non-verbal individuals, those with hearing devices, under seizure treatment, or with a history of heart disease.Check my eligibility
What is being tested?
The Listening Project Protocol (LPP) is being tested to see if it can help people feel calmer and improve their social behavior by reducing auditory hypersensitivity and enhancing speech processing through 'neural exercises'.See study design
What are the potential side effects?
Since LPP involves listening exercises rather than medication, traditional side effects are not expected; however, participants may experience changes in mood or stress levels due to the nature of the intervention.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in auditory hypersensitivity at 1 week, and at 1 month
Secondary outcome measures
Change from baseline in attention (task) at 1 week, and at 2 months
Change from baseline in attention at 1 week, and at 2 months
Change from baseline in auditory processing at 1 week, and at 1 month
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Intervention onlyExperimental Treatment1 Intervention
Participants will be included in 1 pre-intervention and 2 post-assessment measures. Participants will receive the Listening Project Protocol intervention (filtered music). The duration of the intervention is approximately 60 minutes per day, for 5 consecutive days.
Group II: Intervention + StabilityExperimental Treatment1 Intervention
Participants will be included in 2 pre-intervention and 2 post-assessment measures. The additional pre-intervention assessment will allow for assessment of stability of measures. Participants will receive the Listening Project Protocol intervention (filtered music). The duration of the intervention is approximately 60 minutes per day, for 5 consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Listening Project Protocol
2018
N/A
~90
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,632 Total Patients Enrolled
2 Trials studying Stress Disorders
58 Patients Enrolled for Stress Disorders
ADD Centre© and Biofeedback Institute of Toronto©OTHER
Keri J Heilman, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
4 Previous Clinical Trials
512 Total Patients Enrolled
2 Trials studying Stress Disorders
58 Patients Enrolled for Stress Disorders
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You use a hearing aid.You are currently receiving treatment for seizures.You must be between 7 and 55 years old to participate.You have had heart disease in the past.You must have been a client at the ADD Centres Limited & Biofeedback Institute of Toronto.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention only
- Group 2: Intervention + Stability
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial enrolling participants aged twenty and older?
"This medical experiment is only accessible to individuals between the ages of 7 and 55. Notably, there are 248 clinical trials catering specifically for minors and 633 more that cater to elderly patients."
Answered by AI
What are the eligibility requirements for taking part in this trial?
"To qualify for this trial, participants must demonstrate auditory inattention and fall within the specified age range of 7 to 55 years old. Thirty individuals will be admitted into the study overall."
Answered by AI
What is the current threshold for enrollment in this clinical trial?
"Affirmative. According to the information shared on clinicaltrials.gov, this medical study which first appeared online in September 1st 2018 is now actively recruiting participants. The research needs 30 individuals from a single site."
Answered by AI
Is there currently an opportunity for volunteers to join this research trial?
"According to the clinicaltrials.gov directory, this research project is currently searching for participants and was initially published on September 1st 2018 with a recent update posted on November 17th 2022."
Answered by AI
Who else is applying?
What state do they live in?
West Virginia
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
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