Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07424703
Eligibility Criteria:
Inclusion Criteria:
1. Age between 10 and 15 years.
2. Classified as evening chronotype based on the reduced Horne-Östberg Morningness-Eveningness Questionnaire (rMEQ), defined as a score \< 12.
3. Has undergone radiographic evaluation (standing full-spine X-ray) for idiopathic scoliosis at the initial clinic visit.
4. Skeletally immature (Risser sign 0-3) with a major Cobb angle \< 40 degrees at baseline.
5. Written informed consent/assent provided by the participant and legal guardian.
6. Willing and able to comply with the study protocol, including device use and scheduled follow-ups.
Exclusion Criteria:
1. Plans to relocate outside the study area within the next 24 months.
2. Use of medications that may interfere with circadian rhythm within the past 3 months (e.g., lithium, exogenous melatonin, melatonergic antidepressants).
3. Trans-meridian travel across at least two time zones within the past 3 months or anticipated during the study period.
4. Presence of any eye disease (e.g., glaucoma, retinal disease, macular degeneration) that could be exacerbated by or interfere with light therapy.
5. 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).
6. 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
15 Years
Study:
NCT07424703
Study Brief:
Protocol Section:
NCT07424703