Sleep Quality in Adolescents With Idiopathic Scoliosis (AIS-SLEEP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adolescent; Scoliosis; Adolescent Idiopathic Scoliosis (AIS)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ayşe Sena Manzak Dursun, PT, PhD; Phone Number: +905356735150; Email: amanzak@bezmialem.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality Assessed by the Pittsburgh Sleep Quality Index	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Coefficient Between Sleep Quality and Cobb Angle	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	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	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	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	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	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	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)

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: Ayşe Sena Manzak Dursun, Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Estimated): August 7, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 25, 2026

Study Registration Dates

• First Submitted: August 5, 2026
• First Submitted That Met QC Criteria: August 11, 2026
• First Posted (Actual): August 17, 2026

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: August 11, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: adolescent; scoliosis; sleep quality
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Mental Disorders; Spinal Diseases; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Spinal Curvatures; Sleep Initiation and Maintenance Disorders; Scoliosis
• Other Study ID Numbers: BVU-AIS-SLEEP-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No