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Clinical Trial NCT07424703 for Idiopathic Scoliosis, Eveningness, Delayed Sleep Phase is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effect of Bright Light Therapy on Idiopathic Scoliosis 120
Clinical Trial NCT07424703 is an interventional study for Idiopathic Scoliosis, Eveningness, Delayed Sleep Phase that is recruiting. It started on September 1, 2025 with plans to enroll 120 participants. Led by Second Affiliated Hospital of Wenzhou Medical University, it is expected to complete by September 1, 2028. The latest data from ClinicalTrials.gov was last updated on February 20, 2026.
Brief Summary
This trial aims to investigate whether morning bright light therapy can reduce the progression rate of idiopathic scoliosis in children and potentially prevent its de novo development.
Detailed Description
Adolescent idiopathic scoliosis (AIS) is the most common pediatric spinal deformity, characterized by a lateral spinal curvature of ≥10° in the absence of congenital or neuromuscular abnormalities. Afflicting 3-4% of children worldwide, AIS emerges during the vulnerable period of puberty, yet its underlying etiology remains poorly understood. Adolescence is also associated with a gradual shift in circadian rhythm, ch...Show More
Official Title
Effect of Morning Bright Light Therapy on the Onset and Progression of Idiopathic Scoliosis: A Prospective, Single-Blind, Randomized Controlled Trial
Conditions
Idiopathic ScoliosisEveningnessDelayed Sleep PhaseOther Study IDs
- SAHoWMU-CR2025-K-261-01
NCT ID Number
Start Date (Actual)
2025-09-01
Last Update Posted
2026-02-20
Completion Date (Estimated)
2028-09-01
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalBright Light Therapy plus Sleep Hygiene Education Participants will receive: (1) a portable light therapy device for morning use (15-30 minutes each weekday, upon waking) for 6 months; and (2) a one-time, standardized sleep hygiene education session at baseline, including written materials. Regular telephone follow-ups will be conducted to monitor and encourage adherence. | Bright Light Therapy Bright Light Therapy plus Sleep Hygiene Education. Use of a portable light therapy device emitting narrow-band blue light (peak wavelength 480 nm) at an intensity of 400 lux, for 15-30 minutes each weekday morning immediately upon waking, for 6 consecutive months. |
Active ComparatorSleep Hygiene Education Only Participants will receive an identical one-time, standardized sleep hygiene education session and materials as provided to the experimental group. No light therapy device will be provided. | Sleep Hygiene Education Sleep Hygiene Education Only |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Scoliosis Curve Angle | A long standard standing whole spine radiograph will be used for measuring curve size in terms of Cobb angle according to the standard Cobb method | Routine follow-up visits will be scheduled 6 months apart up to 24 months |
Angle of Trunk Rotation | In addition to spinal X-rays, a Scoliometer can also help monitor curve progression. The Scoliometer is an inclinometer that measures the asymmetries between the sides of the trunk by measuring axial rotation in degrees. Numerous studies have found a high correlation between trunk axial rotation (ATR) values and the Cobb angles. | Routine follow-up visits will be scheduled 6 months apart up to 24 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Scoliosis Research Society-22 (SRS-22) questionnaire | The SRS-22 aims to evaluate health-related quality of life (HRQOL) in patients with idiopathic scoliosis. The SRS-22 specifically addresses areas affected by spinal deformities-such as pain, self-perception, function, mental health, and satisfaction with treatment. Consequently, it offers a focused approach to understanding the patient experience. | Routine follow-up visits will be scheduled 6 months apart up to 24 months |
Self-Report Circadian rhythm Measurements | Circadian rhythm as assessed by the reduced Horne-Östberg Morning-Eveningness Questionnaire (rMEQ) | At baseline and months 6 |
Objective Circadian Measurements: Dim-light melatonin onset (DLMO) | Dim-light melatonin onset (express as time value hh:mm) is determined by 6-hours salivary melatonin collected at 1-hour interval. | At baseline and months 6 |
Gene Expression of Circadian Biomarkers | Change in mRNA expression levels of Circadian Genes such as Bmal1 in peripheral blood mononuclear cells as measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR). | At baseline and months 6 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
10 Years
Eligible Sexes
All
- Age between 10 and 15 years.
- Classified as evening chronotype based on the reduced Horne-Östberg Morningness-Eveningness Questionnaire (rMEQ), defined as a score < 12.
- Has undergone radiographic evaluation (standing full-spine X-ray) for idiopathic scoliosis at the initial clinic visit.
- Skeletally immature (Risser sign 0-3) with a major Cobb angle < 40 degrees at baseline.
- Written informed consent/assent provided by the participant and legal guardian.
- Willing and able to comply with the study protocol, including device use and scheduled follow-ups.
Plans to relocate outside the study area within the next 24 months.
Use of medications that may interfere with circadian rhythm within the past 3 months (e.g., lithium, exogenous melatonin, melatonergic antidepressants).
Trans-meridian travel across at least two time zones within the past 3 months or anticipated during the study period.
Presence of any eye disease (e.g., glaucoma, retinal disease, macular degeneration) that could be exacerbated by or interfere with light therapy.
Clinically diagnosed sleep disorder (e.g., narcolepsy, restless legs syndrome) or prominent medical condition known to interfere with sleep continuity and quality (e.g., moderate-to-severe eczema).
Severe chronic health conditions that could confound study outcomes, including but not limited to:
- Known syndromic, neuromuscular, or congenital musculoskeletal causes of scoliosis.
- History of spine surgery or significant spinal trauma.
- Spinal tumor.
- Leg length discrepancy > 20 mm.
- Other severe chronic diseases (e.g., poorly controlled diabetes, chronic liver or renal disease, malabsorption syndromes).
- Severe obesity (body mass index z-score ≥ 3).
Second Affiliated Hospital of Wenzhou Medical UniversityStudy Responsible Party
Xiangyang Wang, Principal Investigator, M.D., Chief physician, Doctorial superviso, Second Affiliated Hospital of Wenzhou Medical University
Study Central Contact
Contact: Xiangyang Wang, 13506663458, [email protected]
1 Study Locations in 1 Countries
Zhejiang
The Second Affiliated Hospital of Wenzhou Medical University, Zhejiang, Zhejiang, 325000, China
Xiangyang Wang, Contact, 13506663458, [email protected]
Recruiting