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

NCT ID: NCT06970418

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-10

Study Completion Date

2024-04-01

Brief Summary

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

Detailed Description

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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

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Attention Deficit Disorder With Hyperactivity Sleep Disorders, Circadian Rhythm Quality of Life Morningness Eveningness Preference

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Behcet Uz Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hande Emine Sabah Barış

Medical Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr. Behcet Uz Children's Hospital

Izmir, Konak, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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832

Identifier Type: -

Identifier Source: org_study_id

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