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Sleep Therapy for Anxiety
N/A
Waitlist Available
Led By Aaron Mattfeld, PhD
Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 10-13 years old
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recall, 12 hours
Awards & highlights
Study Summary
This trial is looking at how well sleep affects people with anxiety who tend to overgeneralize negative experiences.
Who is the study for?
This trial is for children aged 10-13 who experience anxiety symptoms. They must be right-handed, speak English (with a parent fluent in English or Spanish), and able to undergo MRI scans without issues from metal implants or claustrophobia. Children with certain mental health conditions, major medical issues affecting the brain, serious vision/hearing problems, abnormal sleep patterns, or on CNS-affecting meds cannot participate.Check my eligibility
What is being tested?
The study tests how specific memory processes during sleep might contribute to negative overgeneralization in anxious children. It involves comparing the effects of sleeping with sham cues versus sound cues on emotional memory.See study design
What are the potential side effects?
Since this trial focuses on non-invasive interventions involving sleep and auditory cues, there are minimal expected side effects. However, discomfort due to wearing headphones during sleep may occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 10 and 13 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ recall, 12 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recall, 12 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Object Completion Memory Task (behavioral and fMRI)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sleep with Sound CuesExperimental Treatment1 Intervention
Sounds played at time of memory encoding will be replayed during sleep to cue memory processing.
Group II: Sleep with Sham CuesPlacebo Group1 Intervention
Sounds that were not played at time of memory encoding will be played during sleep as a sham comparison
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep with Sound Cues
2018
N/A
~60
Find a Location
Who is running the clinical trial?
Florida International UniversityLead Sponsor
99 Previous Clinical Trials
17,247 Total Patients Enrolled
1 Trials studying Anxiety
53 Patients Enrolled for Anxiety
Aaron Mattfeld, PhDPrincipal InvestigatorFlorida International University
Dana McMakin, PhDPrincipal InvestigatorFlorida International University and Nicklaus Children's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious hearing problem.I have a medical condition that affects my brain function.I have been diagnosed with a mental health or developmental disorder.You have a major vision problem that cannot be fixed with glasses, or if you wear glasses, your prescription is stronger than -5.00 to +3.00. Contact lenses are allowed.I have sleep apnea and my sleep schedule is unusual.I usually sleep less than 6 hours or more than 11 hours, or go to bed after 1:00 am.I experience symptoms of anxiety, including social, generalized, or separation anxiety.I am between 10 and 13 years old.I and my parent can understand and communicate in English or Spanish.You are right-handed.I take medication that affects my brain function.You have shown signs that you may harm yourself or others intentionally.
Research Study Groups:
This trial has the following groups:- Group 1: Sleep with Sound Cues
- Group 2: Sleep with Sham Cues
Awards:
This trial has 0 awards, including: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.
Are there still opportunities to join this research initiative?
"The clinical trial in question is still recruiting participants, with the initial posting taking place on June 1st 2018. The most recent update was made on March 15th 2022, according to clinicialtrials.gov."
Answered by AI
Is the age requirement for enrolment in this study greater than 50 years?
"The parameters for joining this clinical trial require that participants are within the age range of 10 to 13. The data suggests there are 146 studies available for minors and 439 studies targeting seniors."
Answered by AI
How many participants are currently eligible to join this experiment?
"Affirmative. Clinicaltrials.gov documents that this medical study is currently recruiting patients and was posted on June 1st 2018 with a recent update of March 15th 2022. The trial seeks to enrol 60 individuals from two distinct sites."
Answered by AI
What criteria must be met to participate in this medical experiment?
"This clinical trial aims to recruit 60 participants, aged 10-13 years old who suffer from any degree of anxiety. It is imperative that the individuals are right handed and meet either full or partial criteria for Social Phobia, Generalized Anxiety, or Separation Anxiety."
Answered by AI
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