Status:
RECRUITING
Studying Melatonin and Recovery in Teens
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Juvenile; Scoliosis
Scoliosis Idiopathic
Eligibility:
All Genders
12-18 years
Phase:
NA
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...
Detailed Description
The investigators will enroll a total of 45 adolescents ages 12-18 years old who are scheduled to undergo major musculoskeletal surgery and one of their caregivers who meet inclusion and exclusion cri...
Eligibility Criteria
Inclusion
- 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
- Parents/caregivers
- Biological parent or legal guardian of youth
- Can read and understand English
Exclusion
- 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
Key Trial Info
Start Date :
May 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06093477
Start Date
May 30 2024
End Date
March 31 2028
Last Update
February 25 2025
Active Locations (1)
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1
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304