AdolescentAIS-SLEEPNCT07767591
Sleep Quality in Adolescents With Idiopathic Scoliosis
An observational study of Adolescent and Scoliosis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent, Scoliosis, Adolescent Idiopathic Scoliosis (AIS)
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Aug 2026to 25 Dec 2026
- Phase
- Observational
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 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Aged 10-19 years
- No known scoliosis or other spinal deformity
- Able to read and understand Turkish
- Willing to participate voluntarily
Who cannot join
- Presence of a neurological, rheumatological, cardiovascular, or psychiatric condition that may prevent participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul
Ayşe Sena Manzak Dursun, PT, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Adolescent, Scoliosis, Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- scoliosis, adolescent, sleep quality
- Medical subject headings
- Scoliosis, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At study enrollment (single cross-sectional assessment)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At study enrollment (single cross-sectional assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start7 Aug 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdolescentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Sena Manzak, Bezmialem Vakif University
- Investigators
- Ayşe Sena Manzak Dursun, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767591
- Sponsor's protocol ID
- BVU-AIS-SLEEP-2026-01
- Acronym
- AIS-SLEEP
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No