Effect of Bright Light Therapy on Idiopathic Scoliosis

NCT07424703 | Recruiting DMC

• 1 other identifier: SAHoWMU-CR2026-08-112
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Scoliosis; Eveningness; Delayed Sleep Phase

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Scoliosis Research Society-22 (SRS-22) questionnaire

  Routine follow-up visits will be scheduled 6 months apart up to 24 months

• Self-Report Circadian rhythm Measurements

  At baseline and months 6

• Objective Circadian Measurements: Dim-light melatonin onset (DLMO)

  At baseline and months 6

• Gene Expression of Circadian Biomarkers

  At baseline and months 6

Study Arms (2)

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.

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.

Behavioral: Sleep Hygiene Education

Interventions

Bright Light Therapy DEVICE

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.

Bright Light Therapy plus Sleep Hygiene Education

Sleep Hygiene Education BEHAVIORAL

Sleep Hygiene Education Only

Sleep Hygiene Education Only

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University

Zhejiang, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Interventions

Ultraviolet Therapy

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Central Study Contacts

Xiangyang Wang

CONTACT

13506663458; Xiangyangwang@wmu.edu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The radiologists measuring Cobb angles will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Chief physician, Doctorial superviso

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 20, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

CN (1)