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Completed

NCT Number: NCT03737552

Sleep Patterns in Children and Adolescents With ADHD

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.

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Key information

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polysomnography

Other

Polysomnography Is considered as the gold standard of sleep assessment. It combines a number of measures of body function during sleep, including measurement of brain activity(electroencephalography),eye movements(electrooculography ),muscle activity (electromyography),heart rhythm(electrocardiography).

Other names: The Children's Sleep Habits Questionnaire (CSHQ), Pediatric Quality of Life Inventory 4.0 generic version, Conners' continuous performance test

Primary outcomes

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

    Time frame: 1 night

  2. polysomnography to measure sleep efficiency(%) in ADHD patients

    Time frame: 1 night

Secondary outcomes

  1. Assessment of cognitive function in children and adolescents with Attention Deficit Hyperactivity Disorders

    Time frame: 2 hours

    Conners' continuous performance test to assess cognitive function

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 9, 2018
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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