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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
Sponsor:
Information provided by (Responsible Party):
National Aeronautics and Space Administration (NASA)

Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Cognition Pharmacologic Actions Drug: Zolpidem Phase 4

  Show Detailed Description

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
Drug: Zolpidem
Other Name: Zaleplon




Primary Outcome Measures :
  1. Number of lapses of attention [ Time Frame: 3 weeks ]
    The number of lapses of attention on 3 minute Psychomotor Vigilance Test


Secondary Outcome Measures :
  1. Digit Symbol Substitution Test [ Time Frame: 3 weeks ]
    The number of correct responses

  2. Descending Subtraction Test [ Time Frame: 3 weeks ]
    The number of correct responses

  3. Free Recall [ Time Frame: 3 weeks ]
    The number of correctly recalled words

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

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


Sponsors and Collaborators
National Aeronautics and Space Administration (NASA)
Investigators
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Principal Investigator: Smith Johnston, MD JSC NASA
Principal Investigator: David Dinges, PhD University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Aeronautics and Space Administration (NASA)
ClinicalTrials.gov Identifier: NCT03526575     History of Changes
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

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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
Additional relevant MeSH terms:
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Zolpidem
Central Nervous System Depressants
Zaleplon
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
GABA Modulators