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Behavioural Intervention

Cognitive Behavioral Therapy for Sleep Issues from Adverse Childhood Experiences

N/A
Recruiting
Led By Nathaniel Jenkins, PhD
Research Sponsored by Nathaniel Jenkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-29 years of age
Be between 18 and 65 years old
Must not have
Currently undergoing treatment for a sleep disorder or diagnosed with restless leg syndrome, hypersomnia, parasomnia or narcolepsy, or obstructive sleep apnea
Diagnosed neurological disorder or illness affecting the central nervous system
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 (pre-intervention) and week 7 (post-intervention)
Awards & highlights

Summary

This trial aims to investigate how disrupted sleep is related to the impact of early life adversity on the health of blood vessels. They will study how sleep problems contribute to inflammation and oxidative stress in young adults who

Who is the study for?
This trial is for young adults who have had difficult experiences in childhood, like abuse or neglect, which may affect their sleep and heart health. They should be willing to undergo sleep monitoring at home and tests that measure blood vessel health.
What is being tested?
The study looks at how poor sleep might link early life stress to problems with blood vessels. It involves two parts: first measuring participants' sleep and vessel health, then seeing if improving sleep through therapy can help their vessels function better.
What are the potential side effects?
Cognitive Behavioral Therapy for Insomnia (CBT-i) is generally considered safe but may include temporary increases in anxiety or distress as individuals confront and change their sleeping habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 29 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am being treated for a sleep disorder or have been diagnosed with restless leg syndrome, hypersomnia, parasomnia, narcolepsy, or obstructive sleep apnea.
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I have a diagnosed neurological disorder.
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I have been diagnosed with an autoimmune or chronic inflammatory condition.
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I have been diagnosed with cancer.
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I have a history of heart, lung, kidney disease, or diabetes.
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I have used opiates, benzodiazepines, or trazodone in the last month.
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I am currently using hormone therapy.
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I am currently pregnant, breastfeeding, or have a child under 2 years old at home.
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I likely have sleep apnea, shown by my sleep test results or low oxygen levels at night.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 (pre-intervention) and week 7 (post-intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 (pre-intervention) and week 7 (post-intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vascular Endothelial Function
Secondary outcome measures
Anti-oxidant (Catalase) Activity in Peripheral Blood Mononuclear Cells
Anti-oxidant (Glutathione Reductase) Activity in Peripheral Blood Mononuclear Cells
Anti-oxidant (Superoxide Dismutase) Activity in Peripheral Blood Mononuclear Cells
+13 more
Other outcome measures
Anxiety and Depression
Sleep Duration
Sleep Quality
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Behavioral Therapy for Insomnia (CBT-i)Experimental Treatment1 Intervention
Group II: Waitlist ControlActive Control1 Intervention

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Who is running the clinical trial?

Nathaniel JenkinsLead Sponsor
3 Previous Clinical Trials
198 Total Patients Enrolled
Nathaniel Jenkins, PhDPrincipal InvestigatorAssistant Professor
~47 spots leftby Oct 2027
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