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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
What is being tested?
Bright Light Therapy and Sleep Hygiene Education
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
  • The Second Affiliated Hospital of Wenzhou Medical University

    Zhejiang, Zhejiang, 325000

    Xiangyang Wang, 13506663458, Xiangyangwang@wmu.edu.com

    Recruiting

Other trials in China

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.

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 groups in NCT07424703
Study groupRoleWhat they receive
Bright Light Therapy plus Sleep Hygiene EducationExperimentalParticipants 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 OnlyActive comparatorParticipants 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.

  1. 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

  2. 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)
  1. 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

  2. Self-Report Circadian rhythm Measurements

    Circadian rhythm as assessed by the reduced Horne-Östberg Morning-Eveningness Questionnaire (rMEQ)

    Measured: At baseline and months 6

  3. 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

  4. 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.

  1. First posted20 Feb 2026
  2. Study start1 Sep 2025
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

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)
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

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.

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