Attention Deficit Disorder With HyperactivityNCT06970418
Sleep Disorders, Chronotype, and Functional Impairment in the Restrictive ADHD Phenotype
An observational study of Attention Deficit Disorder With Hyperactivity and Sleep Disorders, Circadian Rhythm, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to explore chronotype and sleep disturbances in ADHD subtypes and their relation to functional impairment. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Sleep Disorders, Circadian Rhythm, Quality of Life
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2023to 1 Apr 2024
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of 70 children diagnosed with ADHD, aged between 7 and 12 years, were included in the study. This group consisted of 34 children with predominantly inattentive presentation (ADHD-PI) and 36 children with restrictive presentation (ADHD-R), who were either making their first visit to the Child and Adolescent Psychiatry outpatient clinics or were being followed up with a diagnosis of ADHD-PI or ADHD-R, and had not used psychotropic medication in the past three months. The control group comprised healthy children with similar age and gender distribution, who were evaluated in the Child and Adolescent Psychiatry clinic but did not receive any psychiatric diagnosis following the assessment.
Who may be able to join
- Age between 7 and 12 years
- Willingness to participate in the study with provided consent
- Diagnosis of ADHD according to the Schedule for Affective Disorders and Schizophrenia for School-Age Children - Present and Lifetime Version - Turkish adaptation (K-SADS); no comorbid psychiatric diagnosis (except Oppositional Defiant Disorder)
- Presence of 6 or more inattention symptoms accompanied by 5 or fewer hyperactivity/impulsivity symptoms on the Disruptive Behavior Disorders Rating Scale based on Diagnostic and Statistical Manual of Mental Disorders-IV
- No psychotropic medication use in the past 3 months
Who cannot join
- Families who do not consent to participate in the study
- Children and adolescents with chronic medical conditions and/or currently taking any medications
- Children and adolescents with intellectual disability (mental retardation)
- Children and adolescents with comorbid psychiatric diagnoses
- Presence of a neurological disorder
- History of head trauma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Behcet Uz Children's Hospital
Izmir, Konak, 35000
About this study
This study aims to explore chronotype and sleep disturbances in ADHD subtypes and their relation to functional impairment.
Read the detailed description
The goal of this observational study is to compare morningness-eveningness and sleep disturbances between children diagnosed with Restrictive ADHD (ADHD-R) and those with Predominantly Inattentive ADHD (ADHD-PI), and to examine how these sleep-related features impact functional impairment.The main question it aims to answer is:Are chronotype differences and sleep disturbances associated with greater functional impairment in children with ADHD-R compared to ADHD-PI and typically developing peers?
- Conditions
- Attention Deficit Disorder With Hyperactivity, Sleep Disorders, Circadian Rhythm, Quality of Life, Morningness Eveningness Preference
- Keywords
- ADHD subtypes, Restrictive ADHD, Sleep disorders, Functionality, Morningness Eveningness Preference
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Sleep Disorders, Circadian Rhythm, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Predominantly Inattentive Presentation (ADHD-PI) | Patients selected via random sampling from patients either newly admitted to the clinic or already under follow-up for ADHD-PI, with no psychotropic medication use in the last 3 months. All participants were primary or secondary school students. ADHD subtype classification was determined based on Diagnostic and Statistical Manual of Mental Disorders-5 criteria following clinical interviews and scale assessments completed by both parents and teachers. Children with comorbid psychiatric or chronic medical conditions and those using psychostimulants were excluded. | |
| Restrictive Presentation of ADHD | Patients selected via random sampling from patients either newly admitted to the clinic or already under follow-up for ADHD-R, with no psychotropic medication use in the last 3 months. All participants were primary or secondary school students. ADHD subtype classification was determined based on Diagnostic and Statistical Manual of Mental Disorders-5 criteria following clinical interviews and scale assessments completed by both parents and teachers. Children with comorbid psychiatric or chronic medical conditions and those using psychostimulants were excluded. | |
| control group | The control group consisted of age- and gender-matched children who presented to the Child and Adolescent Psychiatry clinic, were found to have no psychiatric diagnosis after evaluation, and were considered typically developing. Informed consent and assent forms were obtained from all participants and their legal guardians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Disturbance Scores
Total Score on the Children's Sleep Habits Questionnaire (CSHQ) - Short Form Sleep habits and sleep-related problems will be assessed using the Children's Sleep Habits Questionnaire (CSHQ) - Short Form, a 33-item parent-report measure. Items are rated based on the child's behavior over the past week. Each item is scored from 1 to 3, with higher scores indicating more frequent sleep problems. Items 32 and 33 are scored on a 0-2 scale, and items 1, 2, 3, 10, 11, and 26 are reverse-coded. The total score ranges from 33 to 97. A score of 41 or higher is considered clinically significant, indicating problematic sleep.
Time Frame: At baseline (upon enrollment) Units of Measure: Total score (range: 33-97) Interpretation: Higher scores indicate more severe sleep problems.
Measured: At baseline (upon enrollment)
Secondary outcomes (1)
Chronotype classification and total score on the Children's Chronotype Questionnaire (CCQ)
Chronotype preference will be assessed using the Children's Chronotype Questionnaire (CCQ), a parent-report tool adapted from the Munich Chronotype Questionnaire and the Children's Morningness-Eveningness Scale. Items 17-26 determine the chronotype score; items 17, 18, 24, and 25 are reverse-coded. Total scores classify children as morning-type (≤23), intermediate-type (24-32), or evening-type (≥33).
Units of Measure: Chronotype type; total score (range: 10-40); average sleep duration (hours). Higher scores reflect stronger eveningness preference.
Measured: At baseline (upon enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start10 Mar 2023
- Primary completion10 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande Emine Sabah Barış, Dr. Behcet Uz Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970418
- Sponsor's protocol ID
- 832
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data (IPD) including age, sex, diagnosis group (ADHD-R or ADHD-PI), and scores from the CSHQ, CCQ, and WFIRS-P will be shared. Data will be available upon reasonable request to academic researchers with an approved proposal and ethics committee approval.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disorders, Chronotype, and Functional Impairment in the Restrictive ADHD Phenotype
- ClinicalTrials.gov ID
- NCT06970418
- Acronym / sponsor ID
- 832
- Conditions
- Attention Deficit Disorder With Hyperactivity, Sleep Disorders, Circadian Rhythm, Quality of Life, Morningness Eveningness Preference
- Keywords
- ADHD subtypes, Restrictive ADHD, Sleep disorders, Functionality, Morningness Eveningness Preference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 14 May 2025 (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 aims to explore chronotype and sleep disturbances in ADHD subtypes and their relation to functional impairment.
Detailed description
The goal of this observational study is to compare morningness-eveningness and sleep disturbances between children diagnosed with Restrictive ADHD (ADHD-R) and those with Predominantly Inattentive ADHD (ADHD-PI), and to examine how these sleep-related features impact functional impairment.The main question it aims to answer is:Are chronotype differences and sleep disturbances associated with greater functional impairment in children with ADHD-R compared to ADHD-PI and typically developing peers?
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Predominantly Inattentive Presentation (ADHD-PI) | – | –Patients selected via random sampling from patients either newly admitted to the clinic or already under follow-up for ADHD-PI, with no psychotropic medication use in the last 3 months. All participants were primary or secondary school students. ADHD subtype classification was determined based on Diagnostic and Statistical Manual of Mental Disorders-5 criteria following clinical interviews and scale assessments completed by both parents and teachers. Children with comorbid psychiatric or chronic medical conditions and those using psychostimulants were excluded. |
| Restrictive Presentation of ADHD | – | –Patients selected via random sampling from patients either newly admitted to the clinic or already under follow-up for ADHD-R, with no psychotropic medication use in the last 3 months. All participants were primary or secondary school students. ADHD subtype classification was determined based on Diagnostic and Statistical Manual of Mental Disorders-5 criteria following clinical interviews and scale assessments completed by both parents and teachers. Children with comorbid psychiatric or chronic medical conditions and those using psychostimulants were excluded. |
| control group | – | –The control group consisted of age- and gender-matched children who presented to the Child and Adolescent Psychiatry clinic, were found to have no psychiatric diagnosis after evaluation, and were considered typically developing. Informed consent and assent forms were obtained from all participants and their legal guardians. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of 70 children diagnosed with ADHD, aged between 7 and 12 years, were included in the study. This group consisted of 34 children with predominantly inattentive presentation (ADHD-PI) and 36 children with restrictive presentation (ADHD-R), who were either making their first visit to the Child and Adolescent Psychiatry outpatient clinics or were being followed up with a diagnosis of ADHD-PI or ADHD-R, and had not used psychotropic medication in the past three months. The control group comprised healthy children with similar age and gender distribution, who were evaluated in the Child and Adolescent Psychiatry clinic but did not receive any psychiatric diagnosis following the assessment.
Key inclusion criteria (5 listed)
- Age between 7 and 12 years
- Willingness to participate in the study with provided consent
- Diagnosis of ADHD according to the Schedule for Affective Disorders and Schizophrenia for School-Age Children - Present and Lifetime Version - Turkish adaptation (K-SADS); no comorbid psychiatric diagnosis (except Oppositional Defiant Disorder)
- Presence of 6 or more inattention symptoms accompanied by 5 or fewer hyperactivity/impulsivity symptoms on the Disruptive Behavior Disorders Rating Scale based on Diagnostic and Statistical Manual of Mental Disorders-IV
- No psychotropic medication use in the past 3 months
Key exclusion criteria (6 listed)
- Families who do not consent to participate in the study
- Children and adolescents with chronic medical conditions and/or currently taking any medications
- Children and adolescents with intellectual disability (mental retardation)
- Children and adolescents with comorbid psychiatric diagnoses
- Presence of a neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep Disturbance Scores
Time frame: At baseline (upon enrollment)
Total Score on the Children's Sleep Habits Questionnaire (CSHQ) - Short Form Sleep habits and sleep-related problems will be assessed using the Children's Sleep Habits Questionnaire (CSHQ) - Short Form, a 33-item parent-report measure. Items are rated based on the child's behavior over the past week. Each item is scored from 1 to 3, with higher scores indicating more frequent sleep problems. Items 32 and 33 are scored on a 0-2 scale, and items 1, 2, 3, 10, 11, and 26 are reverse-coded. The total score ranges from 33 to 97. A score of 41 or higher is considered clinically significant, indicating problematic sleep. Time Frame: At baseline (upon enrollment) Units of Measure: Total score (range: 33-97) Interpretation: Higher scores indicate more severe sleep problems.
1 secondary outcome
Chronotype classification and total score on the Children's Chronotype Questionnaire (CCQ)
Time frame: At baseline (upon enrollment)
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 14 May 2025.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data (IPD) including age, sex, diagnosis group (ADHD-R or ADHD-PI), and scores from the CSHQ, CCQ, and WFIRS-P will be shared. Data will be available upon reasonable request to academic researchers with an approved proposal and ethics committee approval.
Related trials for Attention Deficit Disorder With Hyperactivity
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Attention Deficit Disorder With Hyperactivity and Sleep Disorders, Circadian Rhythm, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
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 14 May 2025. 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 Turkey (Türkiye). 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?
Sleep Disturbance Scores (time frame: At baseline (upon enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2025.