NCT06093477 Studying Melatonin and Recovery in Teens
| NCT ID | NCT06093477 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Juvenile; Scoliosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-05-30 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2024-05-30 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this feasibility clinical trial is to learn if melatonin can help teens having major musculoskeletal surgery by promoting healthy sleep. Melatonin is available as a dietary supplement that may be effective in promoting longer, higher quality sleep. This study will assess the feasibility and acceptability of melatonin for teens undergoing major musculoskeletal surgery, as well as determine optimal measured outcomes (sleep, pain, health-related quality of life) at short- and long-term follow-up.
Eligibility Criteria
Inclusion Criteria: Patients/youth: * Age 12-18 years * Participants undergoing elective major musculoskeletal surgery for eligible conditions * California state resident * Regular access to internet and smartphone * Can read and understand English or Spanish Parents/caregivers * Biological parent or legal guardian of youth * Can read and understand English or Spanish Exclusion Criteria: Patients/youth * Prescription medication for premorbid insomnia * Cognitive impairment or developmental delay * Does not agree to a 1-week washout if taking over the counter supplements or other sleep aids prior to the start of the study medication * High risk for sleep related breathing disorder * Chronic medical condition that is severe/systemic or requires regular treatment regimen * Psychiatric admission in prior 30 days * Patients that underwent major surgery in the last 3 months, or those that have not fully recovered from a prior surgery * BMI ≥ 99th percentile * Enrollment in another therapeutic study * Any serious underlying medical or psychiatric condition, that, in the opinion of the investigator, would contraindicate the patient's participation in the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06093477 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Juvenile; Scoliosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06093477 currently recruiting?
Yes, NCT06093477 is actively recruiting participants. Contact the research team at surgerysmart@stanford.edu for enrollment information.
Where is the NCT06093477 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT06093477 clinical trial?
NCT06093477 is sponsored by Stanford University. The trial plans to enroll 45 participants.