Sleep Quality in Adolescents With Idiopathic Scoliosis

NCT07767591 | Not Yet Recruiting

• 1 other identifier: BVU-AIS-SLEEP-2026-01
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Adolescent; Scoliosis; Adolescent Idiopathic Scoliosis (AIS)

Keywords

scoliosis; adolescent; sleep quality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Correlation Coefficient Between Sleep Quality and Cobb Angle

  At study enrollment (single cross-sectional assessment)

• Correlation Coefficient Between Sleep Quality and SRS-22 Function/Activity Domain Score

  At study enrollment (single cross-sectional assessment)

• Correlation Coefficient Between Sleep Quality and SRS-22 Pain Domain Score

  At study enrollment (single cross-sectional assessment)

• Correlation Coefficient Between Sleep Quality and SRS-22 Self-Image/Appearance Domain Score

  At study enrollment (single cross-sectional assessment)

• Correlation Coefficient Between Sleep Quality and SRS-22 Mental Health Domain Score

  At study enrollment (single cross-sectional assessment)

Study Arms (2)

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.

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Aged 10-19 years
• Diagnosed with adolescent idiopathic scoliosis by a specialist physician
• Able to read and understand Turkish
• Willing to participate voluntarily

You may not qualify if:

• 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
• Aged 10-19 years
• No known scoliosis or other spinal deformity
• Able to read and understand Turkish
• Willing to participate voluntarily
• Presence of a neurological, rheumatological, cardiovascular, or psychiatric condition that may prevent participation in the study

Sponsors & Collaborators

• Bezmialem Vakif University: lead

MeSH Terms

Conditions

Scoliosis; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Ayşe Sena Manzak Dursun

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşe Sena Manzak Dursun, PT, PhD

CONTACT

+905356735150; amanzak@bezmialem.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant prof. PT, PhD

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 17, 2026
• Study Start: August 7, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share