The Second Affiliated Hospital of Wenzhou Medical University
Zhejiang, 325000, China
Location status: Recruiting
NCT Number: NCT07424703
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.
Interested in participating?
Request Info10 year–15 year
All sexes
Interventional
Not applicable
Zhejiang, 325000, China
Location status: Recruiting
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, characterized by an intrinsic phase delay and increased evening preference that coincides with pubertal development. Notably, our unpublished data reveal that the prevalence of evening chronotype among children with idiopathic scoliosis may reach 20-30%, significantly higher than in the general pediatric population. While circadian disruption is known to adversely affect bone metabolism, muscle mass, and postural control in adults, its impact on children-particularly those with circadian vulnerability-remains unexplored.
We hypothesize that the circadian phase delay and associated sleep disruption during the peripubertal period may represent a modifiable risk factor contributing to the onset or progression of spinal curvature. Bright light therapy is a well-established intervention for circadian rhythm sleep-wake disorders, capable of advancing the circadian phase and stabilizing sleep patterns.
This prospective, single-blind, randomized controlled trial will investigate the efficacy of bright light therapy in modifying the natural history of idiopathic scoliosis. Children with idiopathic scoliosis and a confirmed evening chronotype will be randomized into one of two groups. The Intervention Group will receive a combination of morning bright light exposure and standardized sleep hygiene education. Participants will be instructed to wear a portable light therapy device (480nm, 400LUX) for 15-30 minutes each weekday morning immediately upon waking, for a duration of 6 months. The Control Group will receive identical sleep hygiene education but no light therapy device, serving as an active comparator to control for the effects of increased health awareness and behavioral recommendations. To ensure adherence, the intervention group will receive regular telephone follow-ups to monitor device usage, address challenges, and encourage compliance; flexible adjustment of exposure timing (e.g., mid-morning) will be permitted if morning adherence proves difficult.
For all participants with scoliosis, routine follow-up visits with radiographic assessment will be scheduled at 6-month intervals for at least 24 months to evaluate curve progression. Additionally, children with an evening chronotype but without scoliosis at baseline will also be randomized to the same intervention arms and will undergo annual scoliosis screening as part of an ongoing provincial health initiative. This study may identify a safe, non-pharmacological intervention targeting circadian rhythm as a novel approach to scoliosis management.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Sleep Hygiene Education Only
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months
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
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months
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.
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months
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.
Time frame: At baseline and months 6
Circadian rhythm as assessed by the reduced Horne-Östberg Morning-Eveningness Questionnaire (rMEQ)
Time frame: At baseline and months 6
Dim-light melatonin onset (express as time value hh:mm) is determined by 6-hours salivary melatonin collected at 1-hour interval.
Time frame: At baseline and months 6
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).
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital of Wenzhou Medical University
Other
Effect of Morning Bright Light Therapy on the Onset and Progression of Idiopathic Scoliosis: A Prospective, Single-Blind, Randomized Controlled Trial
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