Optimize Astronaut Sleep Medication Efficacy and Individual Effects
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ClinicalTrials.gov Identifier: NCT03526575 |
Recruitment Status :
Completed
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
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Condition or disease | Intervention/treatment | Phase |
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Sleep Cognition Pharmacologic Actions | Drug: Zolpidem | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | 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. 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. 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, 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. |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Operational Ground Testing Protocol to Optimize Astronaut Sleep Medication Efficacy and Individual Effects |
Actual Study Start Date : | January 10, 2011 |
Actual Primary Completion Date : | July 15, 2015 |
Actual Study Completion Date : | July 15, 2015 |

Arm | Intervention/treatment |
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Placebo Comparator: 10 mg Zolpidem and 10 mg Zaleplon
Experiment 1 will involve N= 14 subjects randomized to placebo , 10 mg zolpidem for males and 10 mg zaleplon in counterbalanced order. Subjects are nested into group.
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Drug: Zolpidem
Other Name: Zaleplon |
Placebo Comparator: 5 mg Zolpidem and 10 mg Zaleplon
Experiment 2, which will involve N=20 subjects randomized to placebo, 5 mg zolpidem and 10 mg zaleplon. All females will be placed in experiment 2. Subjects are nested into group.
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Drug: Zolpidem
Other Name: Zaleplon |
- Number of lapses of attention [ Time Frame: 3 weeks ]The number of lapses of attention on 3 minute Psychomotor Vigilance Test
- Digit Symbol Substitution Test [ Time Frame: 3 weeks ]The number of correct responses
- Descending Subtraction Test [ Time Frame: 3 weeks ]The number of correct responses
- Free Recall [ Time Frame: 3 weeks ]The number of correctly recalled words
- Response time to shut off alarm time [ Time Frame: 3 weeks ]The time subjects require to shut off the awakening simulated International Space Station (ISS) alarm

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
The participant must be an active astronaut or analogous to the astronaut population (e.g., Flight Controllers, Flight Directors, Flight Surgeons, medical residents and medical students on NASA rotation, and NASA /contractor employed University of Texas Medical Branch physician's) to participate in the study. Not Applicable (NA)
Exclusion Criteria:
Pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526575
Principal Investigator: | Smith Johnston, MD | JSC NASA | |
Principal Investigator: | David Dinges, PhD | University of Pennsylvania |
Responsible Party: | National Aeronautics and Space Administration (NASA) |
ClinicalTrials.gov Identifier: | NCT03526575 |
Other Study ID Numbers: |
0925-0586 |
First Posted: | May 16, 2018 Key Record Dates |
Last Update Posted: | May 16, 2018 |
Last Verified: | April 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Zaleplon Zolpidem Sleep Aids, Pharmaceutical Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs GABA-A Receptor Agonists |
GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anticonvulsants GABA Modulators |