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Completed

NCT Number: NCT06970418

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

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

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Chronobiology Disorders Dyssomnias Mental Disorders Morningness Eveningness Preference Nervous System Diseases Neurodevelopmental Disorders Neurologic Manifestations Occupational Diseases Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Sleep Disorders, Circadian Rhythm Sleep Wake Disorders

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Behcet Uz Children's Hospital

Izmir, Konak, 35000, Turkey (Türkiye)

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: At baseline (upon enrollment)

    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.

Other outcomes

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

    Time frame: At baseline (upon enrollment)

    Functional impairment will be assessed using the Weiss Functional Impairment Rating Scale - Parent Form (WFIRS-P), a 50-item Likert-type questionnaire completed by parents. The scale includes six domains: family, school, life skills, self-concept, social activities, and risky behaviors. Each item is rated from 0 ("never") to 3 ("very often"), based on the child's functioning over the past month. Subscale and total scores are calculated by summing item scores and dividing by the number of completed items. Functional impairment in a domain is defined as either scoring 3 on at least one item, 2 on two items, or having a mean score of 1.5 or higher in that domain. overall functional impairment.

    Higher scores indicate greater functional impairment.

Sponsors and collaborators

Lead sponsor

Dr. Behcet Uz Children's Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 14, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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