Sleep Patterns in Children and Adolescents With ADHD

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03737552
• Other study ID #: SPINCD
• Status: Completed
• Start date: April 23, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: January 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: October 15, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• Cognitive Change
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Other:
• Polysomnography
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).

Locations

Country	Name	City	State
Egypt	Assiut	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

Asaad T KO. The Children's Sleep Habits Questionnaire. Psychometric sleep assessment instruments (Arabic version). Cairo: Center Of Psychiatry,Ain Shams University. 2001:11-3.

Cao H, Yan S, Gu C, Wang S, Ni L, Tao H, Shao T, Xu Y, Tao F. Prevalence of attention-deficit/hyperactivity disorder symptoms and their associations with sleep schedules and sleep-related problems among preschoolers in mainland China. BMC Pediatr. 2018 Fe — View Citation

Conners CK, Staff M, Connelly V, Campbell S, MacLean M, Barnes J. Conners' continuous performance Test II (CPT II v. 5). Multi-Health Syst Inc. 2000;29:175-96.

El-Beh K, Hossam Eddin Khalifa H, Hassaan S, Noomani M. Measuring health-related quality of life in children with chronic medical conditions: reliability and validity of the Arabic version of PedsQL 4.0 Generic Core Scales. Middle East Current Psychiatry.

Gad GI, Taha GR. Detection of sleep disturbances in a sample of Egyptian children attending a pediatric outpatient clinic. Middle East Current Psychiatry. 2014;21(3):185-92.

Ibrahim M, Bishry Z, Khaleel A, Ghanem M, Sheehan D, Sheehan K. Comparison of the MINI-kid with K-SADS-PL for school aged children in an Egyptian sample presented with childhood disorders [MD thesis]. Institute of Psychiatry, Ain Shams University Library.

Kalil Neto F, Nunes ML. Evaluation of sleep organization in patients with attention deficit hyperactivity disorder (ADHD) and ADHD as a comorbidity of epilepsy. Sleep Med. 2017 May;33:91-96. doi: 10.1016/j.sleep.2016.08.013. Epub 2016 Oct 22. — View Citation

Lucas I, Mulraney M, Sciberras E. Sleep problems and daytime sleepiness in children with ADHD: Associations with social, emotional, and behavioral functioning at school, a cross-sectional study. Behav Sleep Med. 2019 Jul-Aug;17(4):411-422. doi: 10.1080/15 — View Citation

Wechsler D. Wechsler intelligence scale for children. 1949.

Zulauf Logoz M. [The Revision and 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5): Consequences for the Diagnostic Work with Children and Adolescents]. Prax Kinderpsychol Kinderpsychiatr. 2014;63(7):562-76. doi: 10.13109/p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	polysomnography to measure total sleep time(minutes) in ADHD patients		1 night
Primary	polysomnography to measure sleep efficiency(%) in ADHD patients		1 night
Secondary	Assessment of cognitive function in children and adolescents with Attention Deficit Hyperactivity Disorders	Conners' continuous performance test to assess cognitive function	2 hours