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Clinical Trials/NCT03737552
NCT03737552
Completed
Not Applicable

Sleep Patterns in Children and Adolescents With ADHD: Impact on Cognitive Functions and Quality of Life

Assiut University1 site in 1 country84 target enrollmentApril 23, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Disorder
Sponsor
Assiut University
Enrollment
84
Locations
1
Primary Endpoint
polysomnography to measure total sleep time(minutes) in ADHD patients
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study is aimed to find out Sleep profile differences in children and adolescents with and without ADHD,Relationship between sleep profile disturbance and ADHD symptoms, Impact of sleep disturbance on cognition functions and quality of life.

Detailed Description

Attention deficit hyperactivity disorder (ADHD) is the most common neurodevelopmental disorder of childhood, affecting 3 -5% children \& adolescent worldwide . Inattention, hyperactivity, and impulsiveness are the major ADHD symptoms based on the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition . Sleep has been referred to as a "window to the central nervous system", owing to its close associations with many other neurophysiological variables. Children are highly vulnerable to sleep disruptions in early childhood, perhaps due to the complexity of the sleep process and children's reliance on caregivers for achieving and maintaining sleep . The relationship between sleep and ADHD is a complex process and has gained renewed interest since clinicians and researchers observed that sleep-related problems and complaints are relatively common among children with ADHD .Previous studies have shown that About 25-50% of children and adolescents with ADHD have sleep disorders , including nocturnal awakenings, phase delay, increased night time activity and insomnia. Evaluation of sleep problems in child \&adolescent clinical settings is commonly lacking, often unrecognized and go untreated in clinical setting. So, Untreated sleep disturbances and sleep disorders pose significant adverse daytime consequences and place children at considerable risk for poor health outcomes . Sleep disturbances impair a child's cognitive functioning and contribute to problems with school attendance and performance .

Registry
clinicaltrials.gov
Start Date
April 23, 2019
End Date
October 15, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mustafa M. Hashem

Principal investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Ages 6-17 years inclusive
  • males or females
  • Intelligence Quotient( IQ) \> or equal 80 detected by Wechsler Intelligence Scale for Children .
  • Willingness to comply with all study requirements
  • Inclusion criteria for ADHD group only:
  • confirmed newly diagnosed ADHD according to DSM-5 Criteria. (American Psychiatric Association)

Exclusion Criteria

  • History of chronic/significant medical condition
  • History or Current prescribed use of any psychotropics, including non-stimulant medications for ADHD.
  • History or Current substance abuse or dependence.
  • First degree relative with psychosis or bipolar disorder.
  • Exclusion for the ADHD group only:
  • Meets criteria for any other psychiatric comorbidity Disorder besides ADHD or Oppositional Defiant Disorder (ODD).
  • Exclusion for the Healthy Control group only:
  • Meets criteria for any psychiatric Disorders.

Outcomes

Primary Outcomes

polysomnography to measure total sleep time(minutes) in ADHD patients

Time Frame: 1 night

polysomnography to measure sleep efficiency(%) in ADHD patients

Time Frame: 1 night

Secondary Outcomes

  • Assessment of cognitive function in children and adolescents with Attention Deficit Hyperactivity Disorders(2 hours)

Study Sites (1)

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