Listening Project Protocol for Auditory Inattention

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Auditory Inattention+3 More
Listening Project Protocol - Behavioral
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the feasibility of the Listening Project Protocol intervention in individuals with difficulties with autonomic and/or behavioral regulation.

Eligible Conditions
  • Auditory Inattention
  • Stress Disorders

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention

Month 1
Change from baseline in social behavior at 1 week, and at 1 month
Month 1
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 middle ear transfer function at 1 week, and at 1 month
Change from baseline in prosody at 1 week, and at 2 months
Month 1
Change from baseline in auditory hypersensitivity at 1 week, and at 1 month
Change from baseline in auditory processing at 1 week, and at 1 month
Change from baseline in state regulation at 1 week, and at 1 month

Trial Safety

Trial Design

2 Treatment Groups

Intervention only
1 of 2
Intervention + Stability
1 of 2
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Listening Project Protocol · No Placebo Group · N/A

Intervention only
Behavioral
Experimental Group · 1 Intervention: Listening Project Protocol · Intervention Types: Behavioral
Intervention + Stability
Behavioral
Experimental Group · 1 Intervention: Listening Project Protocol · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Listening Project Protocol
2015
N/A
~60

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre-intervention (within 1 week before intervention), post-intervention (within 1 week after intervention), 1 month post-intervention

Who is running the clinical trial?

ADD Centre© and Biofeedback Institute of Toronto©OTHER
University of North Carolina, Chapel HillLead Sponsor
1,359 Previous Clinical Trials
3,927,038 Total Patients Enrolled
Keri J Heilman, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
2 Previous Clinical Trials
58 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: October 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
West Virginia100.0%
How old are they?
65+100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%