Sleep Disorders, Chronotype, and Functional Impairment in the Restrictive ADHD Phenotype

NCT06970418 | Completed

• 1 other identifier: 832
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore chronotype and sleep disturbances in ADHD subtypes and their relation to functional impairment.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline (upon enrollment)

Secondary Outcomes (1)

• Chronotype classification and total score on the Children's Chronotype Questionnaire (CCQ)

  At baseline (upon enrollment)

Other Outcomes (1)

• Functional impairment scores on the Weiss Functional Impairment Rating Scale - Parent Form (WFIRS-P)

  At baseline (upon enrollment)

Study Arms (3)

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.

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead

Study Sites (1)

Dr. Behcet Uz Children's Hospital

Izmir, Konak, 35000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Sleep Disorders, Circadian Rhythm; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Occupational Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Resident

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 14, 2025
• Study Start: March 10, 2023
• Primary Completion: March 10, 2024
• Study Completion: April 1, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

TU (1)