Optimize Astronaut Sleep Medication Efficacy and Individual Effects

NCT03526575 | Completed Phase 4

• 1 other identifier: 0925-0586
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep; Cognition; Pharmacologic Actions

Outcome Measures

Primary Outcomes (1)

• Number of lapses of attention

  The number of lapses of attention on 3 minute Psychomotor Vigilance Test

  3 weeks

Secondary Outcomes (4)

• Digit Symbol Substitution Test

  3 weeks

• Descending Subtraction Test

  3 weeks

• Free Recall

  3 weeks

• Response time to shut off alarm time

  3 weeks

Study Arms (2)

10 mg Zolpidem and 10 mg Zaleplon

PLACEBO COMPARATOR

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

5 mg Zolpidem and 10 mg Zaleplon

PLACEBO COMPARATOR

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

Interventions

Zolpidem DRUG

Also known as: Zaleplon

10 mg Zolpidem and 10 mg Zaleplon; 5 mg Zolpidem and 10 mg Zaleplon

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• National Aeronautics and Space Administration (NASA): lead

Related Publications (1)

• Dinges DF, Basner M, Ecker AJ, Baskin P, Johnston SL. Effects of zolpidem and zaleplon on cognitive performance after emergent morning awakenings at Tmax: a randomized placebo-controlled trial. Sleep. 2019 Mar 1;42(3):zsy258. doi: 10.1093/sleep/zsy258.

  PMID: 30576525 DERIVED

MeSH Terms

Interventions

Zolpidem; zaleplon

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Smith Johnston, MD

  JSC NASA

  PRINCIPAL INVESTIGATOR

• David Dinges, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: May 16, 2018
• Study Start: January 10, 2011
• Primary Completion: July 15, 2015
• Study Completion: July 15, 2015
• Last Updated: May 16, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share