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Recruiting NCT07636525

Sleep and Adolescent Vaccine Immunogenicity Pilot/Observational Study

Conditions: Vaccination

Sex: All
Ages: 11 Years – 12 Years
Healthy volunteers: Yes
Enrollment: 66
Sponsor: Children's Hospital Medical Center, Cincinnati

Location: Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Summary

This study tests whether the sleep habits of 11-12 years-olds impact their response to a vaccine that protects against meningococcal illness. That vaccine is typically given at that age by primary care doctors, but nobody has studied how sleep affects children's response to it. This could be important because research on adults suggests that sleep affects the immune system. Families will have their child keep their regular sleep schedule during the 5-week study. They will wear a special wristwatch at night to track their sleep. Each day they will fill out a short online form. They and a parent/guardian will come to Cincinnati Children's twice for 1 - 1 ½ hours. During the first visit, the child get the vaccine. During the second, they have a blood test.

Eligibility Criteria

Inclusion Criteria: * Healthy 11-12 years olds who have neither had initial meningococcal vaccination nor known exposure to meningococcal illness. Exclusion Criteria: * Condition or treatment resulting in immunosuppression * Prior severe vaccine reaction * Symptoms of clinical insomnia or organic sleep disorder * Known neurologic condition or intellectual/developmental disability * Use of a medication that impacts sleep * Average nightly sleep of 8-8.99 hours (between the two groups) * Daily intake of \>1 coffee or "energy drink" or \>2 caffeinated sodas.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07636525). StuddyBuddy aggregates publicly available trial information.