Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sleep Patterns in Children and Adolescents With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03737552
Recruitment Status : Completed
First Posted : November 9, 2018
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Mustafa M. Hashem, Assiut University

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.

Condition or disease Intervention/treatment
Sleep Disorder ADHD Cognitive Change Other: Polysomnography

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 .

Layout table for study information
Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Sleep Patterns in Children and Adolescents With ADHD: Impact on Cognitive Functions and Quality of Life
Actual Study Start Date : April 23, 2019
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : October 15, 2020

Group/Cohort Intervention/treatment
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
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

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
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 Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737552


Locations
Layout table for location information
Egypt
Assiut
Assiut, Egypt
Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Study Chair: Tarek Assad, Doctorate Ain Shams University
Publications of Results:
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.
Wechsler D. Wechsler intelligence scale for children. 1949.
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.
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.
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.
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.

Layout table for additonal information
Responsible Party: Mustafa M. Hashem, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03737552    
Other Study ID Numbers: SPINCD
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mustafa M. Hashem, Assiut University:
Sleep
ADHD
Children
Cognition
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders