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Office for Human Research Protections (OHRP)

Sleep Mechanisms in Children: Role of Metabolism


Requesting IRB:

Yeshiva University, Albert Einstein College of Medicine, Montefiore Medical Center

Study Summary:

This research protocol proposes to measure glycogen, glutamate turnover rate, and glutamate-glutamine cycling in wakefulness and sleep in adolescent children ages 13 to 17 years. The investigator also proposes to study a subset of children in a similar manner following sleep deprivation. The study involves three visits to the hospital at Montefiore Medical Center. Measurements use magnetic resonance spectroscopy following intravenous infusion of 13C-acetate and 13C-glucose. The long-term aims of the study are to better understand (a) sleep; (b) the diseases afflicting children and adults that impact on their sleep; and (c) sleep-related diseases that impact on neurocognitive, cardiovascular, behavioral, and other functions.

Funding Source:

National Heart, Lung and Blood Institute/National Institutes of Health

  1. HHS determination
  2. OHRP letter to Yeshiva University regarding determination

Expert reports

NIH grant, excerpts

Informed consent (adult) and assent (child/minor)

IRB Documents

Federal Register notice requesting public comments

Correspondence between OHRP and Research Institution




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