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Sleep and Emotion Processing in Childhood

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ClinicalTrials.gov Identifier: NCT03330093
Recruitment Status : Unknown
Verified October 2017 by University of Colorado, Boulder.
Recruitment status was:  Enrolling by invitation
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Boulder

Brief Summary:
This research project will examine whether experimental sleep extension in children alters the neural and behavioral mechanisms by which short sleep is a risk factor for emotional/behavioral problems. Children ages 5.0-5.9 years with chronic insufficient sleep (≤9 h/night for ≥6 months) will be randomized to either a sleep Extension or to an active Control group. Extension group parents will participate in a 1-month individualized behavioral sleep intervention to promote targeted sleep duration improvements before beginning a 2-week sleep Extension schedule (8 week protocol). Brain and behavioral assessments will occur at Baseline and post sleep Extension.

Condition or disease Intervention/treatment Phase
Sleep Emotions Behavioral: Sleep Health in Preschoolers Behavioral: Health and Safety Intervention Not Applicable

Detailed Description:

Research on processes influencing the development of affective brain circuits is critical to elucidating the neurobiological substrates of psychiatric disorders. Mechanistic evidence from adults showing a sleep-dependent functional "disconnect" between brain regions central to adaptive emotion processing (i.e., regulation and expression) suggests that sleep loss is a fundamental target. Similar data in young children, however, do not exist. Early childhood is a sensitive period in the maturation of sleep and emotion processing and also a time when disturbance in both domains is commonly first detected. Further, epidemiological findings reveal that insufficient sleep in childhood is prevalent, associated with concurrent emotional problems, and predicts later mood and attentional disorders. Although the investigator's recent experimental findings indicate that acute sleep loss results in non-adaptive emotion processing in young children, the neural systems underlying such sleep-dependent effects are not known. Also, the vast majority of basic research on sleep and affective substrates has utilized sleep deprivation or sleep restriction protocols. The investigators will instead employ sleep extension in chronically sleep-restricted children, a highly translatable approach with significant public health implications.

This research project will examine whether experimental sleep extension in children alters the neural and behavioral mechanisms by which short sleep is a risk factor for emotional/behavioral problems. Children ages 5.0-5.9 years with chronic insufficient sleep (≤9 h/night for ≥6 months) will be randomized to either a sleep Extension or to an active Control group. Extension group parents will participate in a 1-month individualized behavioral sleep intervention to promote targeted sleep duration improvements before beginning a 2-week sleep Extension schedule (8 week protocol). Brain and behavioral assessments will occur at Baseline and post sleep Extension.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Sleep and the Neural Basis of Emotion Processing in Childhood
Actual Study Start Date : August 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: Sleep Extension
1-month educational and problem solving behavioral intervention about sleep.
Behavioral: Sleep Health in Preschoolers
In-person, family-based behavioral intervention

Active Comparator: Health and Safety
1-month educational and problem solving behavioral intervention about health and safety.
Behavioral: Health and Safety Intervention
In-person, family-based behavioral intervention




Primary Outcome Measures :
  1. MRI/fMRI [ Time Frame: Change from Baseline at 10 weeks ]
    Brain Scans to assess neural substrates of emotion


Secondary Outcome Measures :
  1. Emotion Regulation Checklist [ Time Frame: Change from Baseline at 10 weeks ]
    Parent report questionnaire to assess emotion regulation



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

4.0-6.9 years Reportedly obtain ≤9 h of sleep/night for ≥6 months

Exclusion Criteria:

Nocturnal sleep disturbance determined by clinical cut-offs on the Children's Sleep Habits Questionnaire and the Pediatric Sleep Questionnaire Medications Developmental disabilities Chronic medical conditions Low-birth weight or pre-term term delivery Family history of psychiatric disorders Living at altitude <1 year Metal implants or Claustrophobia

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Responsible Party: University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT03330093    
Other Study ID Numbers: 0214.04.0421B
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Boulder:
Children