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

2026年8月11日 更新者：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.

研究概览

地位

尚未招聘

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

是的

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Sleep Quality Assessed by the Pittsburgh Sleep Quality Index
大体时间：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)

次要结果测量

结果测量
措施说明
大体时间
Correlation Coefficient Between Sleep Quality and Cobb Angle
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bezmialem Vakif University

调查人员

  • 首席研究员：Ayşe Sena Manzak Dursun、Bezmialem Vakif University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月7日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2026年12月25日

研究注册日期

首次提交

2026年8月5日

首先提交符合 QC 标准的

2026年8月11日

首次发布 (实际的)

2026年8月17日

研究记录更新

最后更新发布 (实际的)

2026年8月17日

上次提交的符合 QC 标准的更新

2026年8月11日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BVU-AIS-SLEEP-2026-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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