Idiopathic ScoliosisNCT07424703
Effect of Bright Light Therapy on Idiopathic Scoliosis
A study testing Bright Light Therapy and Sleep Hygiene Education in people with Idiopathic Scoliosis and Eveningness, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Idiopathic Scoliosis, Eveningness, Delayed Sleep Phase
- What is being tested?
- Bright Light Therapy and Sleep Hygiene Education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Zhejiang, Zhejiang, 325000
Xiangyang Wang, 13506663458, Xiangyangwang@wmu.edu.com
About this study
Official title: Effect of Morning Bright Light Therapy on the Onset and Progression of Idiopathic Scoliosis: A Prospective, Single-Blind, Randomized Controlled Trial
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.
Read the 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, 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.
- Conditions
- Idiopathic Scoliosis, Eveningness, Delayed Sleep Phase
- Being tested
- Bright Light Therapy, Sleep Hygiene Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Light TherapyDevice
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 EducationBehavioural
Sleep Hygiene Education Only
| Study group | Role | What they receive |
|---|---|---|
| Bright Light Therapy plus Sleep Hygiene Education | Experimental | 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. Receives: Device: Bright Light Therapy |
| Sleep Hygiene Education Only | Active comparator | 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. Receives: Behavioral: Sleep Hygiene Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Routine follow-up visits will be scheduled 6 months apart up to 24 months
Secondary outcomes (4)
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.
Measured: 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)
Measured: 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.
Measured: 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).
Measured: At baseline and months 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Sep 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangyang Wang, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424703
- Sponsor's protocol ID
- SAHoWMU-CR2026-08-112
- Status last verified
- May 2026
- First submitted
- 14 Feb 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Morning Bright Light Therapy on the Onset and Progression of Idiopathic Scoliosis: A Prospective, Single-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07424703
- Acronym / sponsor ID
- SAHoWMU-CR2026-08-112
- Conditions
- Idiopathic Scoliosis, Eveningness, Delayed Sleep Phase
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright Light Therapy plus Sleep Hygiene Education | Experimental | Device: Bright Light TherapyParticipants 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. |
| Sleep Hygiene Education Only | Active comparator | Behavioral: Sleep Hygiene EducationParticipants 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. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright Light TherapyBright 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. | Device | Bright Light Therapy plus Sleep Hygiene Education |
| Sleep Hygiene EducationSleep Hygiene Education Only | Behavioural | Sleep Hygiene Education Only |
Primary outcome
Scoliosis Curve Angle
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
Angle of Trunk Rotation
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.
4 secondary outcomes
Scoliosis Research Society-22 (SRS-22) questionnaire
Time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months
Self-Report Circadian rhythm Measurements
Time frame: At baseline and months 6
Objective Circadian Measurements: Dim-light melatonin onset (DLMO)
Time frame: At baseline and months 6
Gene Expression of Circadian Biomarkers
Time frame: At baseline and months 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Idiopathic Scoliosis
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Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
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Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Light Therapy and Sleep Hygiene Education in people with Idiopathic Scoliosis and Eveningness, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangyang Wang (13506663458, Xiangyangwang@wmu.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoliosis Curve Angle (time frame: Routine follow-up visits will be scheduled 6 months apart up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.