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Chronic ConditionsSCACNCT07210476

Turkish Adaptation of a Sleep Screening Tool for Pediatric Complex Chronic Conditions

An observational study of Chronic Conditions and Pediatric Intensive Care, run by Marmara University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to adapt the Sleep Screening Scale for Children and Adolescents with Complex Chronic Conditions (SCAC) into Turkish and test its reliability and validity for this population. Children and adolescents with complex chronic conditions (CCC) often have ongoing and multiple health problems. Read more about this study

Who is it for?
Ages 1 month to 18 years
How many people
330 participants
Where
1 siteTurkey (Türkiye)
Study dates
12 Mar 2026to Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 1 month to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Children aged 1 months-18 years with at least one complex chronic condition (defined by the 2014 CCC classification)

Who may be able to join

  • Age 1 month to 18 years At least one complex chronic condition (per 2014 CCC classification) Admission to a pediatric intensive care unit (PICU) Parents willing to participate Parents literate in Turkish

Who cannot join

  • Parents with insufficient Turkish language proficiency to complete study materials

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elif Ozturk contact

+905056584040

eozturk@marun.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

  • Marmara University School of Medicine, Department of Pediatrics, Division of Social Pediatrics

    Istanbul

    Perran Boran, drperran@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Turkish Adaptation and Psychometric Evaluation of the Sleep Screening Tool for Children and Adolescents With Complex Chronic Conditions

This study aims to adapt the Sleep Screening Scale for Children and Adolescents with Complex Chronic Conditions (SCAC) into Turkish and test its reliability and validity for this population. Children and adolescents with complex chronic conditions (CCC) often have ongoing and multiple health problems. These children often face a high risk of sleep problems, but there are no screening tools in Turkish designed specifically for them.

The main goal is to confirm that the Turkish version of the SCAC is accurate and reliable. The study will also look at how common different types of sleep problems are in children with CCC, and how these problems are related to factors such as diagnosis, age, sex, and other medical conditions.

Another goal is to compare children's sleep at home with their sleep during a stay in the pediatric intensive care unit (PICU). The study will also examine how environmental factors (such as light and noise) and medical factors (such as pain, medications, and devices) affect sleep in the hospital. After discharge, sleep recovery will be followed for up to 3 months using sleep diaries and actigraphy (a wearable device that measures movement during sleep).

Read the detailed description

This multi-phase, prospective observational study is designed to evaluate sleep disturbances among children with complex chronic conditions (CCCs), focusing on both the hospital period-specifically pediatric intensive care units (PICUs)-and the post-discharge transition to home. The study incorporates both subjective (questionnaire-based) and objective (actigraphy-based) assessments and integrates a family-centered, developmentally appropriate, and biopsychosocial framework.

The first phase involves the cross-cultural adaptation and psychometric validation of the "Sleep Screening Tool for Children and Adolescents with Complex Chronic Conditions (SCAC)" into Turkish. This includes forward and backward translation, expert panel review, cognitive interviews with caregivers, and a pilot study. Validity (via exploratory factor analysis using principal components analysis with varimax rotation) and internal consistency (via Cronbach's alpha) will be tested. Test-retest reliability will be evaluated by re-administering the scale one month after discharge to 50 participants.

In the second phase, children admitted to one of the largest tertiary PICU in Türkiye will be recruited. During hospitalization, sleep-wake patterns will be continuously monitored using actigraphy, while environmental factors including noise and light exposure will be recorded using calibrated sensors placed at the bedside. Nurses will assist with administering tools and maintaining logs. Additional clinical variables such as medications, nighttime interventions, pain scores, and disease severity will also be recorded. The study setting enables inclusion of a high-volume and diverse pediatric population.

Following discharge, longitudinal follow-up will be conducted using the SCAC tool and sleep diaries at four time points: Day 15, Month 1, Month 2, and Month 3. Parental consent will include approval for follow-up via telephone and SMS reminders. One nurse-researcher will conduct structured phone interviews and provide diary reminders. Post-discharge sleep recovery will be evaluated based on comparison to PICU scores and pre-hospital baseline sleep as reported by parents.

This study is the first in Türkiye, to adapt and validate a sleep screening scale specifically designed for CCC. This research not only focuses on scale development but also aims to generate scientific data that could inform environmental improvements in hospital settings.

Keywords
sleep, sleep disorder, child, chronic disease, actigraphy
Medical subject headings
Chronic Disease, Sleep Wake Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychometric validation of the Turkish version of the Sleep Screening Scale for Children and Adolescents with Complex Chronic Conditions (SCAC)

    Description: The primary outcome is the psychometric validation of the Sleep Screening Scale for Children and Adolescents with Complex Chronic Conditions (SCAC), originally developed by Larissa Alice Kubek and adapted into Turkish (Kronik Karmaşık Durumu Olan Çocuklar ve Ergenler İçin Uyku Tarama Anketi; KUBA) through forward-backward translation. The scale consists of 29 items grouped into four factors based on the International Classification of Sleep Disorders - Third Edition (ICSD-3) diagnostic categories:

    Sleep initiation and maintenance (7 items)

    Sleep-related breathing and arousals (9 items)

    Daytime sleepiness (7 items)

    Sleep-related movements (6 items)

    Each item is rated for the frequency of symptoms in the past 7 days, with higher scores indicating a greater presence of sleep-related problems. The total score ranges from 0 to 203, and subscale scores range from 0 to 63 depending on the number of items in each factor. Internal consistency will be assessed using Cronbach's

    Measured: At enrollment (hospitalization)

  2. Test-retest reliability of the Turkish version of the SCAC

    Test-retest reliability will be assessed in a subgroup of participants by re-administering the SCAC at least four weeks after discharge from the pediatric intensive care unit (PICU). Reliability will be calculated using intraclass correlation coefficients (ICCs) for the total and subscale scores

    Measured: At least 4 weeks post-discharge from PICU

  3. Prevalence and subtype distribution of sleep disturbances in children with Complex Chronic Conditions (CCC)

    Sleep disturbances will be assessed using the SCAC Scale. The questionnaire has 29 items; each item is rated for frequency of occurrence in the past 7 days (0 = never, 7 = every day). Four subscale scores are calculated based on the SCAC domains: (1) Sleep initiation and maintenance (7 items, score range 0-49), (2) Sleep-related breathing and arousals (9 items, score range 0-63), (3) Daytime sleepiness (7 items, score range 0-49), and (4) Sleep-related movements (6 items, score range 0-42). The total score ranges from 0 to 203, with higher scores indicating greater presence of sleep-related problems.

    Measured: At enrollment (hospitalization)

Secondary outcomes (6)

  1. Objective sleep parameters during PICU stay

    Objective sleep will be assessed using wrist actigraphy, placed on Day 1 of PICU admission in participants for whom actigraphy is feasible, and corroborated with sleep diaries and nursing observation logs. The primary reported metric will be sleep efficiency, calculated as total sleep time ÷ total sleep opportunity × 100% per night and averaged across the PICU stay. Higher percentages indicate better sleep efficiency. Additional exploratory parameters (total sleep time, number of awakenings, longest uninterrupted sleep period) will be collected to characterize sleep patterns and for quality checks, but not as separate outcome measures.

    Measured: During PICU hospitalization (up to 30 days)

  2. Correlation of environmental and clinical factors with sleep efficiency (actigraphy and sleep diaries)

    The primary outcome will be sleep efficiency measured using actigraphy and daily sleep diaries. Sleep efficiency will be calculated as: total sleep time ÷ total sleep opportunity × 100%, and averaged across the PICU stay. Correlation analyses will be conducted between sleep efficiency and: Light exposure (lux; actigraphy ambient light channel), Sound exposure (dB; bedside calibrated sound level meter), Nighttime nursing interventions (nursing observation logs), Pain (Face, Legs, Activity, Cry, Consolability scale, (0-10) ; Numeric Rating Scale (0-10)) Disease severity (Pediatric Logistic Organ Dysfunction-2 daily score) Medication exposure (yes/no, for sedatives, and related medications).

    Exploratory sleep parameters will also be derived from actigraphy and diaries, including:

    Total sleep time (minutes/night), Number of awakenings (count/night), Longest uninterrupted sleep period (minutes/night). These will be reported for descriptive analyses but not as separate outcome measures

    Measured: From Day 1 of PICU admission through discharge (up to 30 days)

  3. Comparison of home and hospital sleep patterns

    Sleep patterns will be assessed with the SCAC in Complex chronic conditions. Parents will report the home baseline sleep over the previous 7 days before admission, and the SCAC will be administered in the PICU on Day 7 of admission or at discharge whichever comes first. The outcome will be the change in SCAC scores. SCAC total scores range from 0-203; higher scores indicate greater sleep-related problems.

    Measured: Home baseline: parent-reported 7 days prior to admission; PICU: Day 7 of admission or at discharge if earlier

  4. Change in SCAC Scores From Hospitalization to 3 Months Post-Discharge

    Sleep problems will be assessed with the SCAC after discharge. SCAC will be administered at Day 15, Month 1, Month 2, and Month 3 post-discharge. The primary reported value is the change in SCAC scores from hospitalization to Month 3. SCAC total score range: 0-203; higher scores indicate worse sleep-related problems.

    Measured: Baseline (hospitalization),15 days, 1,2, 3 months post-discharge

  5. Time to Return to Pre-Hospital Sleep-Wake Pattern

    Caregiver-completed sleep diaries and wake time logs will be used to monitor bedtime, wake time, and daytime napping patterns from hospitalization through 3 months post-discharge. Pre-hospital baseline is defined as the parent-reported sleep diary for the 7 days prior to admission. "Recovery" will be defined as the first date on which the sleep-wake schedule returns to the caregiver's perception of the child's typical pre-hospital pattern, based on diary entries. The primary reported value is the number of days from hospital discharge to recovery (censored at 90 days)

    Measured: Baseline (hospitalization),15 days, 1,2, 3 months post-discharge

  6. Correlation of clinical and environmental factors with delayed recovery of sleep-wake patterns

    Delayed recovery is defined as return to the baseline sleep-wake pattern (caregiver-completed sleep diaries) occurring later than the median recovery time in the study cohort. The primary reported value will be time to recovery (days) after hospital discharge.

    Correlation analyses will be conducted with the following predictors:

    Disease severity: Pediatric Logistic Organ Dysfunction-2 (PELOD-2) daily score,

    Complex Chronic Condition (CCC) subtype: e.g., neurologic, cardiac, metabolic, other,

    ICU length of stay: days,

    Baseline sleep problems: SCAC total score (0-203),

    Environmental stressors:

    Light exposure (lux; measured by actigraphy ambient light channel),

    Sound exposure (dB; bedside calibrated sound level meter).

    Measured: From hospital discharge through 90 days post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2025
  2. Study start12 Mar 2026
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07210476
Sponsor's protocol ID
24.06.2025-73
Acronym
SCAC
Status last verified
Mar 2026
First submitted
24 Jul 2025
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data may be shared upon reasonable request depending on ethical approvals, participant consent, and institutional policies. Any data sharing will follow strict guidelines to ensure confidentiality and data protection, especially due to the involvement of pediatric patients with complex medical conditions. Requests for sharing of individual participant data will be evaluated on a case-by-case basis. If researchers express interest (e.g., based on publications or institutional announcements), data sharing requests can be submitted through a formal application process.

Publications

  • Kubek LA, Claus B, Rostasy K, Bertolini A, Schimmel M, Fruhwald MC, Classen G, Zernikow B, Wager J. Development and preliminary validation of the Sleep Screening for Children and Adolescents with Complex Chronic Conditions (SCAC). J Sleep Res. 2023 Aug;32(4):e13881. doi: 10.1111/jsr.13881. Epub 2023 Mar 16.

    PubMed 36929532

  • Comrey AL. Factor-analytic methods of scale development in personality and clinical psychology. J Consult Clin Psychol. 1988 Oct;56(5):754-61. doi: 10.1037//0022-006x.56.5.754. No abstract available.

    PubMed 3057010

  • Kudchadkar SR, Aljohani OA, Punjabi NM. Sleep of critically ill children in the pediatric intensive care unit: a systematic review. Sleep Med Rev. 2014 Apr;18(2):103-10. doi: 10.1016/j.smrv.2013.02.002. Epub 2013 May 21.

    PubMed 23702219

  • Knauert MP, Ayas NT, Bosma KJ, Drouot X, Heavner MS, Owens RL, Watson PL, Wilcox ME, Anderson BJ, Cordoza ML, Devlin JW, Elliott R, Gehlbach BK, Girard TD, Kamdar BB, Korwin AS, Lusczek ER, Parthasarathy S, Spies C, Sunderram J, Telias I, Weinhouse GL, Zee PC. Causes, Consequences, and Treatments of Sleep and Circadian Disruption in the ICU: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2023 Apr 1;207(7):e49-e68. doi: 10.1164/rccm.202301-0184ST.

    PubMed 36999950

  • Hybschmann J, Topperzer MK, Gjaerde LK, Born P, Mathiasen R, Sehested AM, Jennum PJ, Sorensen JL. Sleep in hospitalized children and adolescents: A scoping review. Sleep Med Rev. 2021 Oct;59:101496. doi: 10.1016/j.smrv.2021.101496. Epub 2021 Apr 26.

    PubMed 33984632

  • Berger J, Zaidi M, Halferty I, Kudchadkar SR. Sleep in the Hospitalized Child: A Contemporary Review. Chest. 2021 Sep;160(3):1064-1074. doi: 10.1016/j.chest.2021.04.024. Epub 2021 Apr 22.

    PubMed 33895129

  • Adavadkar PA, Brooks L, Pappalardo AA, Schwartz A, Rasinski K, Martin MA. Association between sleep disorders and health care utilization in children with chronic medical conditions: a Medicaid claims data analysis. J Clin Sleep Med. 2024 Apr 1;20(4):595-601. doi: 10.5664/jcsm.10936.

    PubMed 38217477

  • Namisango E, Bristowe K, Allsop MJ, Murtagh FEM, Abas M, Higginson IJ, Downing J, Harding R. Symptoms and Concerns Among Children and Young People with Life-Limiting and Life-Threatening Conditions: A Systematic Review Highlighting Meaningful Health Outcomes. Patient. 2019 Feb;12(1):15-55. doi: 10.1007/s40271-018-0333-5.

    PubMed 30361884

  • Dreier LA, Zernikow B, Stening K, Wager J. Insights into the Frequency and Distinguishing Features of Sleep Disorders in Pediatric Palliative Care Incorporating a Systematic Sleep Protocol. Children (Basel). 2021 Jan 17;8(1):54. doi: 10.3390/children8010054.

    PubMed 33477321

  • Shelton AR, Malow B. Neurodevelopmental Disorders Commonly Presenting with Sleep Disturbances. Neurotherapeutics. 2021 Jan;18(1):156-169. doi: 10.1007/s13311-020-00982-8. Epub 2021 Jan 5.

    PubMed 33403472

  • Blackmer AB, Feinstein JA. Management of Sleep Disorders in Children With Neurodevelopmental Disorders: A Review. Pharmacotherapy. 2016 Jan;36(1):84-98. doi: 10.1002/phar.1686.

    PubMed 26799351

  • Bai G, Herten MH, Landgraf JM, Korfage IJ, Raat H. Childhood chronic conditions and health-related quality of life: Findings from a large population-based study. PLoS One. 2017 Jun 2;12(6):e0178539. doi: 10.1371/journal.pone.0178539. eCollection 2017.

    PubMed 28575026

  • Xavier WDS, Abreu MP, Nunes MDR, Silva-Rodrigues FM, da Silva LF, de Araujo BBM, De Bortoli PS, Neris RR, Nascimento LC. The Sleep Patterns of Children and Adolescents with Chronic Conditions and Their Families: An Integrative Literature Review. Children (Basel). 2024 Feb 6;11(2):207. doi: 10.3390/children11020207.

    PubMed 38397320

  • Feudtner C, Feinstein JA, Zhong W, Hall M, Dai D. Pediatric complex chronic conditions classification system version 2: updated for ICD-10 and complex medical technology dependence and transplantation. BMC Pediatr. 2014 Aug 8;14:199. doi: 10.1186/1471-2431-14-199.

    PubMed 25102958

  • Oliveira PV, Enes CC, Nucci LB. How are children with medical complexity being identified in epidemiological studies? A systematic review. World J Pediatr. 2023 Oct;19(10):928-938. doi: 10.1007/s12519-022-00672-9. Epub 2022 Dec 27.

    PubMed 36574212

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Conditions and Pediatric Intensive Care, run by Marmara University 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elif Ozturk (+905056584040, eozturk@marun.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychometric validation of the Turkish version of the Sleep Screening Scale for Children and Adolescents with Complex Chronic Conditions (SCAC) (time frame: At enrollment (hospitalization)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07210476, which also lists 16 linked publications.

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 17 Apr 2026.

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