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Studying Melatonin and Recovery in Teens

NCT06093477 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

  • Juvenile; Scoliosis
  • Scoliosis Idiopathic
  • Scoliosis; Adolescence
  • Scoliosis;Congenital
  • Kyphosis
  • Spondylolisthesis
  • Pectus Surgery
  • Hip Surgery

Interventions

DIETARY_SUPPLEMENT

Fast-Dissolve Melatonin Pill

Participants in this arm will take 3mg of melatonin in fast-dissolve pill form daily during the specified study period.

OTHER

Fast-Dissolve Placebo Pill

Participants in this arm will take 3mg of placebo in fast-dissolve pill form daily during the specified study period.

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Stanford University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-30
Primary Completion
2026-10-01
Completion
2028-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06093477 on ClinicalTrials.gov