Sleep Patterns in Children and Adolescents With ADHD

NCT03737552 | Completed

• 1 other identifier: SPINCD
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder; ADHD; Cognitive Change

Keywords

Sleep; ADHD; Children; Cognition

Outcome Measures

Primary Outcomes (2)

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

  1 night

• polysomnography to measure sleep efficiency(%) in ADHD patients

  1 night

Secondary Outcomes (1)

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

  2 hours

Study Arms (2)

Children and adolescents with ADHD

Children and Adolescents with ADHD children or Adolescents, male or female, ages 6-17, confirmed diagnosis of Attention Deficit Hyperactivity Disorder (inattentive, hyperactive/impulsive, or combined presentations), medically healthy, no comorbid psychiatric diagnosis other than ODD, intelligence within normal limits. Participants will complete 1 night of polysomnography at sleep lab and a neuropsychological and quality of life assessment in the lab.

Other: Polysomnography

Healthy control children and adolescent

children or Adolescents, male or female, ages 6-17,medically healthy, no psychiatric diagnoses, intelligence within normal limits. Participants will complete 1 night of polysomnography at sleep lab and a neuropsychological and quality of life assessment in the lab.

Other: Polysomnography

Interventions

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).

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

Children and adolescents with ADHD; Healthy control children and adolescent

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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
• confirmed newly diagnosed ADHD according to DSM-5 Criteria. (American Psychiatric Association)

You may not qualify if:

• 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.
• Meets criteria for any other psychiatric comorbidity Disorder besides ADHD or Oppositional Defiant Disorder (ODD).
• Meets criteria for any psychiatric Disorders.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut

Asyut, Egypt

Location

Related Publications (10)

• 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: 10.1080/15402002.2017.1376207. Epub 2017 Oct 13.

  PMID: 28922019 RESULT

• 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/prkk.2014.63.7.562. German.

  PMID: 25478714 RESULT

• 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 Feb 19;18(1):70. doi: 10.1186/s12887-018-1022-1.

  PMID: 29458356 RESULT

• 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.

  PMID: 28449914 RESULT

• 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.

  RESULT

• Wechsler D. Wechsler intelligence scale for children. 1949.

  RESULT

• 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. 2002.

  RESULT

• 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.

  RESULT

• 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. 2018;25(1):16-22.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Sleep Wake Disorders; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Study Officials

• Tarek Assad, Doctorate

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 9, 2018
• Study Start: April 23, 2019
• Primary Completion: September 30, 2020
• Study Completion: October 15, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)