Clinical Trial Finder

Studying Melatonin and Recovery in Teens

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 12 Years - 18 Years
Gender All
More Inclusion & Exclusion 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.
Parents/caregivers.
  • - Biological parent or legal guardian of youth.
  • - Can read and understand English.

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06093477
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Stanford University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Juvenile; Scoliosis, Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis;Congenital, Kyphosis, Spondylolisthesis, Pectus Surgery, Hip Surgery
Additional Details

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 criteria. Participants will be asked to: 1. Take melatonin or a placebo before and after surgery. All participants will receive sleep hygiene instructions. 2. Wear a watch-like actigraphy device before and after surgery. 3. Complete 1-minute check-in surveys twice each day, for about 5 weeks total before and after surgery. 4. Complete 10-20-minute online surveys 3 times over 4 months. Researchers will compare participants randomized to the placebo arm and melatonin arm to see if the trial design and outcomes are both feasible and acceptable to patients and their families. The main aims are: Aim 1. To assess the feasibility and acceptability of melatonin for youth undergoing musculoskeletal surgery Aim 2. To determine optimal primary and secondary outcomes (sleep, pain, health-related quality of life) at short-term (during the initial 21 days) and at final follow-up (3 months after surgery). The investigators will examine completion rates, the extent and pattern of missing data, and gather data to provide effect estimates, variances, and 95% confidence intervals.

Arms & Interventions

Arms

Placebo Comparator: 3mg fast-dissolve pill

Participants will take a placebo of 3mg fast-dissolve pill (without melatonin), complete surveys, and wear an actigraphy device during the specified study period.

Experimental: 3mg fast-dissolve pill (containing melatonin)

Participants will take 3mg in fast-dissolve pill form containing the active ingredient melatonin, complete surveys, and wear an actigraphy device during the specified study period.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Lucile Packard Children's Hospital, Palo Alto, California

Status

Recruiting

Address

Lucile Packard Children's Hospital

Palo Alto, California, 94304

Site Contact

Jennifer A Rabbitts, M.D.

[email protected]

650-725-0540

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