Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 12:15 AM
Study NCT ID:
NCT07424703
Status:
RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Bright Light Therapy on Idiopathic Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014467', 'term': 'Ultraviolet Therapy'}], 'ancestors': [{'id': 'D010789', 'term': 'Phototherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The radiologists measuring Cobb angles will be blinded to treatment allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-14', 'studyFirstSubmitDate': '2026-02-14', 'studyFirstSubmitQcDate': '2026-02-14', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scoliosis Curve Angle', 'timeFrame': 'Routine follow-up visits will be scheduled 6 months apart up to 24 months', 'description': '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'}, {'measure': 'Angle of Trunk Rotation', 'timeFrame': 'Routine follow-up visits will be scheduled 6 months apart up to 24 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Scoliosis Research Society-22 (SRS-22) questionnaire', 'timeFrame': 'Routine follow-up visits will be scheduled 6 months apart up to 24 months', 'description': '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.'}, {'measure': 'Self-Report Circadian rhythm Measurements', 'timeFrame': 'At baseline and months 6', 'description': 'Circadian rhythm as assessed by the reduced Horne-Östberg Morning-Eveningness Questionnaire (rMEQ)'}, {'measure': 'Objective Circadian Measurements: Dim-light melatonin onset (DLMO)', 'timeFrame': 'At baseline and months 6', 'description': 'Dim-light melatonin onset (express as time value hh:mm) is determined by 6-hours salivary melatonin collected at 1-hour interval.'}, {'measure': 'Gene Expression of Circadian Biomarkers', 'timeFrame': 'At baseline and months 6', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Scoliosis', 'Eveningness', 'Delayed Sleep Phase']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nWe 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.\n\nThis 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.\n\nFor 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 10 and 15 years.\n2. Classified as evening chronotype based on the reduced Horne-Östberg Morningness-Eveningness Questionnaire (rMEQ), defined as a score \\< 12.\n3. Has undergone radiographic evaluation (standing full-spine X-ray) for idiopathic scoliosis at the initial clinic visit.\n4. Skeletally immature (Risser sign 0-3) with a major Cobb angle \\< 40 degrees at baseline.\n5. Written informed consent/assent provided by the participant and legal guardian.\n6. Willing and able to comply with the study protocol, including device use and scheduled follow-ups.\n\nExclusion Criteria:\n\n1. Plans to relocate outside the study area within the next 24 months.\n2. Use of medications that may interfere with circadian rhythm within the past 3 months (e.g., lithium, exogenous melatonin, melatonergic antidepressants).\n3. Trans-meridian travel across at least two time zones within the past 3 months or anticipated during the study period.\n4. Presence of any eye disease (e.g., glaucoma, retinal disease, macular degeneration) that could be exacerbated by or interfere with light therapy.\n5. 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).\n6. Severe chronic health conditions that could confound study outcomes, including but not limited to:\n\n * Known syndromic, neuromuscular, or congenital musculoskeletal causes of scoliosis.\n * History of spine surgery or significant spinal trauma.\n * Spinal tumor.\n * Leg length discrepancy \\> 20 mm.\n * Other severe chronic diseases (e.g., poorly controlled diabetes, chronic liver or renal disease, malabsorption syndromes).\n * Severe obesity (body mass index z-score ≥ 3).'}, 'identificationModule': {'nctId': 'NCT07424703', 'briefTitle': 'Effect of Bright Light Therapy on Idiopathic Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'Effect of Morning Bright Light Therapy on the Onset and Progression of Idiopathic Scoliosis: A Prospective, Single-Blind, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SAHoWMU-CR2025-K-261-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bright Light Therapy plus Sleep Hygiene Education', 'description': '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.', 'interventionNames': ['Device: Bright Light Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sleep Hygiene Education Only', 'description': '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.', 'interventionNames': ['Behavioral: Sleep Hygiene Education']}], 'interventions': [{'name': 'Bright Light Therapy', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Bright Light Therapy plus Sleep Hygiene Education']}, {'name': 'Sleep Hygiene Education', 'type': 'BEHAVIORAL', 'description': 'Sleep Hygiene Education Only', 'armGroupLabels': ['Sleep Hygiene Education Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325000', 'city': 'Zhejiang', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangyang Wang', 'role': 'CONTACT', 'email': 'Xiangyangwang@wmu.edu.com', 'phone': '13506663458'}], 'facility': 'The Second Affiliated Hospital of Wenzhou Medical University'}], 'centralContacts': [{'name': 'Xiangyang Wang', 'role': 'CONTACT', 'email': 'Xiangyangwang@wmu.edu.com', 'phone': '13506663458'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Chief physician, Doctorial superviso', 'investigatorFullName': 'Xiangyang Wang', 'investigatorAffiliation': 'Second Affiliated Hospital of Wenzhou Medical University'}}}}