Clinical trial NCT03737552: Sleep Patterns in Children and Adolescents With ADHD
Official title: Sleep Patterns in Children and Adolescents With ADHD: Impact on Cognitive Functions and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorder
ADHD
Cognitive Change
Keywords: Sleep
ADHD
Children
Cognition
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 84
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will involve recruitment of 51 children and adolescents with ADHD and a control group of 51 healthy childern and adolescents without psychiatric diagnoses. Participants will participate in 3 stages : Screening stage , Sleep Study stage , and Neurocognitive and quality of life assessment stage . To ensure consistency in sleep schedules, 1 night of the sleep study will occur on weeknights during the school year. The neurocognitive and quality of life assessment will occur during the afternoon following the final night of sleep assessment.

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 .

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.

Primary outcomes:
measure: polysomnography to measure total sleep time(minutes) in ADHD patients
timeFrame: 1 night
measure: polysomnography to measure sleep efficiency(%) in ADHD patients
timeFrame: 1 night
Secondary outcomes:
measure: Assessment of cognitive function in children and adolescents with Attention Deficit Hyperactivity Disorders
timeFrame: 2 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut
Study officials:
affiliation: Ain Shams University
name: Tarek Assad, Doctorate
role: STUDY_CHAIR
References:
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