Clinical trial NCT06970418: Sleep Disorders, Chronotype, and Functional Impairment in the Restrictive ADHD Phenotype
Official title: Sleep Disorders, Chronotype, and Functional Impairment in the Restrictive ADHD Phenotype
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Dr. Behcet Uz Children's Hospital
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 104
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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?

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sleep Disturbance Scores
timeFrame: At baseline (upon enrollment)
Secondary outcomes:
measure: Chronotype classification and total score on the Children's Chronotype Questionnaire (CCQ)
timeFrame: At baseline (upon enrollment)
Other outcomes:
measure: Functional impairment scores on the Weiss Functional Impairment Rating Scale - Parent Form (WFIRS-P)
timeFrame: At baseline (upon enrollment)
Locations:
city: İzmir
country: Turkey
facility: Dr. Behcet Uz Children's Hospital
state: Konak
Study officials:
References: