Sleep Patterns in Children and Adolescents With ADHD

January 11, 2021 updated by: Mustafa M. Hashem, Assiut University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
polysomnography to measure total sleep time(minutes) in ADHD patients
Time Frame: 1 night
1 night
polysomnography to measure sleep efficiency(%) in ADHD patients
Time Frame: 1 night
1 night

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Tarek Assad, Doctorate, ain shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

October 15, 2020

Study Registration Dates

First Submitted

November 2, 2018

First Submitted That Met QC Criteria

November 8, 2018

First Posted (Actual)

November 9, 2018

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPINCD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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