Sleep DisorderNCT03737552
Sleep Patterns in Children and Adolescents With ADHD
An observational study of Sleep Disorder and ADHD, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder, ADHD, Cognitive Change
- What is being tested?
- Polysomnography
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Apr 2019to 15 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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 .
- Conditions
- Sleep Disorder, ADHD, Cognitive Change
- Being tested
- Polysomnography
- Keywords
- Sleep, ADHD, Children, Cognition
- Medical subject headings
- Sleep Wake Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyOther
Also called The Children's Sleep Habits Questionnaire (CSHQ), Pediatric Quality of Life Inventory 4.0 generic version, Conners' continuous performance test
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
polysomnography to measure total sleep time(minutes) in ADHD patients
Measured: 1 night
polysomnography to measure sleep efficiency(%) in ADHD patients
Measured: 1 night
Secondary outcomes (1)
Assessment of cognitive function in children and adolescents with Attention Deficit Hyperactivity Disorders
Conners' continuous performance test to assess cognitive function
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start23 Apr 2019
- Primary completion30 Sep 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa M. Hashem, Assiut University
- Investigators
- Tarek Assad, Doctorate, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737552
- Sponsor's protocol ID
- SPINCD
- Status last verified
- Jan 2021
- First submitted
- 2 Nov 2018
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28922019Zulauf 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.
PubMed 25478714Cao 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.
PubMed 29458356Kalil 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.
PubMed 28449914Gad 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Patterns in Children and Adolescents With ADHD: Impact on Cognitive Functions and Quality of Life
- ClinicalTrials.gov ID
- NCT03737552
- Acronym / sponsor ID
- SPINCD
- Conditions
- Sleep Disorder, ADHD, Cognitive Change
- Keywords
- Sleep, ADHD, Children, Cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children and adolescents with ADHD | – | Other: PolysomnographyChildren 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. |
| Healthy control children and adolescent | – | Other: Polysomnographychildren 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographyAlso: The Children's Sleep Habits Questionnaire (CSHQ), Pediatric Quality of Life Inventory 4.0 generic version, Conners' continuous performance testPolysomnography 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 | Children and adolescents with ADHD, Healthy control children and adolescent |
Primary outcome
polysomnography to measure total sleep time(minutes) in ADHD patients
Time frame: 1 night
polysomnography to measure sleep efficiency(%) in ADHD patients
Time frame: 1 night
1 secondary outcome
Assessment of cognitive function in children and adolescents with Attention Deficit Hyperactivity Disorders
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Results publication: PubMed 28922019Lucas 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.
- Results publication: PubMed 25478714Zulauf 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.
- Results publication: PubMed 29458356Cao 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.
- Results publication: PubMed 28449914Kalil 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.
- Results publicationGad 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.
- Results publicationWechsler D. Wechsler intelligence scale for children. 1949.
- Results publicationIbrahim 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.
- Results publicationAsaad T KO. The Children's Sleep Habits Questionnaire. Psychometric sleep assessment instruments (Arabic version). Cairo: Center Of Psychiatry,Ain Shams University. 2001:11-3.
- Results publicationEl-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.
- Results publicationConners 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Assad, Doctorate study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder and ADHD, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
polysomnography to measure total sleep time(minutes) in ADHD patients (time frame: 1 night). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03737552, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.