Optimize Astronaut Sleep Medication Efficacy and Individual Effects
Status:
Completed
Trial end date:
2015-07-15
Target enrollment:
Participant gender:
Summary
In the study titled Operational Ground Testing Protocol to Optimize Astronaut Sleep
Medication Efficacy and Individual Effects (Phase 11), two randomized , blinded ,
placebo-controlled , cross-over trials will be conducted. The hypnotic medication and the
placebo will be indistinguishable by subjects. Experiment 1 will involve N=14 subjects
randomized to placebo , 10 mg Zolpidem (Ambien) and 10 mg Zaleplon (Sonata) in
counterbalanced order and will be awakened 90 min. post-placebo administration (half at 60
min and half at 90 min). The latter will be done to maintain some degree of blinding relative
to the participants knowledge of conditions and the staff working on the protocol. Zolpidem
is the most commonly , and Zaleplon is the second most commonly , used sleep aid medication
used in spaceflight. Females and those subjects who have had a previous adverse experience
with 10 mg zolpidem will be placed into Experiment 2, which will involve N=20 subjects
randomized to placebo , 5 mg zolpidem and 10 mg zaleplon. Data acquisition for both
experiments will occur in the Astronaut Quarantine Facility ("AQF") at Johnson Space Center
(JSC). Experimental methods and cognitive outcomes will be the same as those used in the
pilot investigation titled Develop and Implement Operational Ground Testing Protocols to
Individualize Astronaut Sleep Medication Efficacy and Individual Effects (Phase I). Combined
, Experiment 1 and 2 will provide data on zaleplon 10 mg compared to placebo on a total of 34
subjects consisting of astronauts and other subjects considered analogous to the astronaut
population (e.g., Flight Controllers, Flight Directors , Flight Surgeons, medical residents
and medical students on National Aeronautics and Space Administration (NASA) rotation, and
NASA/contractor employed University of Texas Medical Branch physician's) , which will provide
the larger sample needed to identify those subjects who have cognitive performance deficits
on abrupt awakening to the less sedating 10 mg zaleplon.
Phase:
Phase 4
Details
Lead Sponsor:
National Aeronautics and Space Administration (NASA)