Sleep Quality in Adolescents With Idiopathic Scoliosis (AIS-SLEEP)
11 augustus 2026 bijgewerkt door: Ayşe Sena Manzak, Bezmialem Vakif University
Sleep Quality and Associated Factors in Adolescents With Idiopathic Scoliosis: A Controlled Cross-Sectional Study
This controlled cross-sectional observational study aims to compare sleep quality between adolescents with idiopathic scoliosis and age- and sex-similar healthy controls.
Participants aged 10-18 years will complete online questionnaires assessing demographic characteristics and sleep quality.
Adolescents with idiopathic scoliosis will also be evaluated for scoliosis-specific quality of life, body image, Cobb angle, curve type, pain, brace use, and daily brace-wearing duration.
The study will additionally investigate factors associated with sleep quality in the scoliosis group.
The planned enrollment is 100 participants, including 50 adolescents with idiopathic scoliosis and 50 healthy controls.
Studie Overzicht
Toestand
Nog niet aan het werven
Gedetailleerde beschrijving
This controlled cross-sectional observational study is designed to evaluate sleep quality in adolescents with idiopathic scoliosis (AIS) and to compare their sleep quality with that of age- and sex-similar healthy controls. The study will include participants aged 10-18 years and will enroll approximately 100 individuals, consisting of 50 adolescents with AIS and 50 healthy controls.
Data will be collected online using Google Forms. All participants will complete a demographic information form and the Pittsburgh Sleep Quality Index (PSQI). The demographic form will include information on age, sex, height, weight, screen time, physical activity level, sleep duration, sleep environment, and sleep habits.
Participants in the AIS group will additionally complete the Scoliosis Research Society-22 Questionnaire (SRS-22). Clinical information specific to scoliosis, including Cobb angle, curve type, pain, brace use, and daily brace-wearing duration, will also be recorded. Cobb angle and curve type will be obtained from available medical records or the most recent radiological evaluation report.
The primary analysis will compare sleep quality between the AIS and healthy control groups. Secondary analyses will investigate relationships between PSQI total score and scoliosis-related, psychosocial, and treatment-related factors, including Cobb angle, pain, scoliosis-specific quality of life, brace use, and daily brace-wearing duration. Correlation analyses and multiple linear regression will be used to identify factors independently associated with sleep quality within the AIS group.
No intervention, medication, radiological imaging, or physical examination will be performed as part of the study. Participation will consist of completing the online questionnaires, while relevant scoliosis-related clinical data will be verified from existing medical records.
Studietype
Observationeel
Inschrijving (Geschat)
100
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Ayşe Sena Manzak Dursun, PT, PhD
- Telefoonnummer: +905356735150
- E-mail: amanzak@bezmialem.edu.tr
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Ja
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
The study population consists of adolescents aged 10-19 years with adolescent idiopathic scoliosis who were previously referred from the Orthopedics and Traumatology Outpatient Clinic to the Orthopedic Training and Research Laboratory, and age- and sex-similar healthy adolescents without known scoliosis or another spinal deformity.
Data are collected online from eligible volunteers using Google Forms.
Clinical scoliosis-related information is verified from available medical records and radiological reports.
Beschrijving
Inclusion Criteria for the Adolescent Idiopathic Scoliosis Group:
- Aged 10-19 years
- Diagnosed with adolescent idiopathic scoliosis by a specialist physician
- Able to read and understand Turkish
- Willing to participate voluntarily
Exclusion Criteria for the Adolescent Idiopathic Scoliosis Group:
- Having a type of scoliosis other than adolescent idiopathic scoliosis
- Previous spinal surgery
- Presence of a neurological, rheumatological, cardiovascular, or psychiatric condition that may prevent participation in the study
Inclusion Criteria for the Healthy Control Group:
- Aged 10-19 years
- No known scoliosis or other spinal deformity
- Able to read and understand Turkish
- Willing to participate voluntarily
Exclusion Criteria for the Healthy Control Group:
- Presence of a neurological, rheumatological, cardiovascular, or psychiatric condition that may prevent participation in the study
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Adolescents With Idiopathic Scoliosis
Adolescents aged 10-18 years with a diagnosis of adolescent idiopathic scoliosis.
Participants complete a demographic information form, the Pittsburgh Sleep Quality Index, and the Scoliosis Research Society-22 Questionnaire.
Scoliosis-related clinical data, including Cobb angle, curve type, pain, brace use, and daily brace-wearing duration, are also recorded.
No intervention is assigned.
|
|
Healthy Controls
Age- and sex-similar healthy adolescents aged 10-18 years without known scoliosis or another spinal deformity.
Participants complete a demographic information form and the Pittsburgh Sleep Quality Index.
No intervention is assigned.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Sleep Quality Assessed by the Pittsburgh Sleep Quality Index
Tijdsspanne: At study enrollment (single cross-sectional assessment)
|
Sleep quality during the previous month will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
The PSQI global score ranges from 0 to 21 points, with higher scores indicating poorer sleep quality.
The primary comparison will be the difference in PSQI global scores between adolescents with idiopathic scoliosis and age- and sex-similar healthy controls.
|
At study enrollment (single cross-sectional assessment)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Correlation Coefficient Between Sleep Quality and Cobb Angle
Tijdsspanne: At study enrollment (single cross-sectional assessment)
|
The correlation between sleep quality and scoliosis curve magnitude will be evaluated in participants with adolescent idiopathic scoliosis using the Pittsburgh Sleep Quality Index (PSQI) global score and Cobb angle.
The PSQI global score ranges from 0 to 21 points, with higher scores indicating poorer sleep quality.
Cobb angle will be obtained from the most recent available radiological evaluation and recorded in degrees.
The reported outcome will be the Pearson or Spearman correlation coefficient, as appropriate, ranging from -1 to +1.
|
At study enrollment (single cross-sectional assessment)
|
|
Correlation Coefficient Between Sleep Quality and SRS-22 Function/Activity Domain Score
Tijdsspanne: At study enrollment (single cross-sectional assessment)
|
The correlation between sleep quality and physical function will be evaluated in participants with adolescent idiopathic scoliosis using the Pittsburgh Sleep Quality Index (PSQI) global score and the function/activity domain score of the Scoliosis Research Society-22 Questionnaire (SRS-22).
The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
The SRS-22 function/activity domain score ranges from 1 to 5, with higher scores indicating better function.
The relationship will be reported as a Pearson or Spearman correlation coefficient, as appropriate, ranging from -1 to +1.
|
At study enrollment (single cross-sectional assessment)
|
|
Correlation Coefficient Between Sleep Quality and SRS-22 Pain Domain Score
Tijdsspanne: At study enrollment (single cross-sectional assessment)
|
The correlation between sleep quality and pain will be evaluated in participants with adolescent idiopathic scoliosis using the Pittsburgh Sleep Quality Index (PSQI) global score and the pain domain score of the Scoliosis Research Society-22 Questionnaire (SRS-22).
The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
The SRS-22 pain domain score ranges from 1 to 5, with higher scores indicating less pain and a better health status.
The relationship will be reported as a Pearson or Spearman correlation coefficient, as appropriate, ranging from -1 to +1.
|
At study enrollment (single cross-sectional assessment)
|
|
Correlation Coefficient Between Sleep Quality and SRS-22 Self-Image/Appearance Domain Score
Tijdsspanne: At study enrollment (single cross-sectional assessment)
|
The correlation between sleep quality and self-image/appearance will be evaluated in participants with adolescent idiopathic scoliosis using the Pittsburgh Sleep Quality Index (PSQI) global score and the self-image/appearance domain score of the Scoliosis Research Society-22 Questionnaire (SRS-22).
The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
The SRS-22 self-image/appearance domain score ranges from 1 to 5, with higher scores indicating a better perception of self-image and appearance.
The relationship will be reported as a Pearson or Spearman correlation coefficient, as appropriate, ranging from -1 to +1.
|
At study enrollment (single cross-sectional assessment)
|
|
Correlation Coefficient Between Sleep Quality and SRS-22 Mental Health Domain Score
Tijdsspanne: At study enrollment (single cross-sectional assessment)
|
The correlation between sleep quality and mental health will be evaluated in participants with adolescent idiopathic scoliosis using the Pittsburgh Sleep Quality Index (PSQI) global score and the mental health domain score of the Scoliosis Research Society-22 Questionnaire (SRS-22).
The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
The SRS-22 mental health domain score ranges from 1 to 5, with higher scores indicating better mental health.
The relationship will be reported as a Pearson or Spearman correlation coefficient, as appropriate, ranging from -1 to +1.
|
At study enrollment (single cross-sectional assessment)
|
|
Pittsburgh Sleep Quality Index Global Score by Brace Use Status
Tijdsspanne: At study enrollment (single cross-sectional assessment)
|
Sleep quality will be evaluated according to brace use status in participants with adolescent idiopathic scoliosis using the Pittsburgh Sleep Quality Index (PSQI).
The PSQI global score ranges from 0 to 21 points, with higher scores indicating poorer sleep quality.
The reported outcome will be the PSQI global score in brace users and non-users.
|
At study enrollment (single cross-sectional assessment)
|
|
Pittsburgh Sleep Quality Index Global Score by Daily Brace-Wearing Duration
Tijdsspanne: At study enrollment (single cross-sectional assessment)
|
Among participants with adolescent idiopathic scoliosis who use a brace, sleep quality will be evaluated according to daily brace-wearing duration.
Daily brace-wearing duration will be categorized as less than 8 hours, 8-12 hours, 12-16 hours, 16-20 hours, or more than 20 hours per day.
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which has a global score ranging from 0 to 21 points, with higher scores indicating poorer sleep quality.
The reported outcome will be the PSQI global score within each brace-wearing duration category.
|
At study enrollment (single cross-sectional assessment)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ayşe Sena Manzak Dursun, Bezmialem Vakif University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
7 augustus 2026
Primaire voltooiing (Geschat)
1 december 2026
Studie voltooiing (Geschat)
25 december 2026
Studieregistratiedata
Eerst ingediend
5 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
11 augustus 2026
Eerst geplaatst (Werkelijk)
17 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
11 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BVU-AIS-SLEEP-2026-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .