Artemis Sleep Countermeasures

Part of paid clinical trials in Mountain View, California.

Sponsor
National Aeronautics and Space Administration (NASA)
Study ID
NCT06531733
Status
Recruiting
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Conditions

  • Fatigue

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Sleep Promoting (pink noise) — DEVICE
    Participants will be provided with comfortable headphones to wear throughout their daytime sleep opportunity. The headphones will deliver a continuous pink noise sound no greater than 50 decibels. Participants will be allowed to turn down the sound of the pink noise if they find it too loud. Participants will wear the headphones with no noise during the placebo condition.
  • Wake Promoting (blue enriched light plus a nap) — DEVICE
    Participants randomized to the blue-enriched light and nap condition will have the blue-enriched light turned on during their nighttime stay in the lab. The light will be turned off for up to one hour during the nap. During the placebo condition, participants will have an overhead room light of \~150 lux illuminated throughout their nighttime stay in the lab. This light level reflects an older NASA standard which was used in the design of some Artemis vehicles. During the placebo condition, participants will be asked to engage in quiet activities such as reading for one hour.

Study Details

Purpose. The purpose of this study is to test sleep and wake-promoting countermeasures to evaluate their effectiveness in helping individuals fall asleep quickly, maintain sleep during a nap, and maintain alertness during waking. Protocol Overview. The proposed study involves two laboratory visits separated by at least one week. Participants are required to complete all procedures in the companion screening and at-home protocol in order to qualify for this laboratory protocol. The at-home protocol involves keeping a regular schedule for 2-3 weeks. Participants will need to maintain a regular schedule with at least 8.5 hours in bed for at least one week prior to the first laboratory visit. They will then continue the at-home protocol, maintaining at least 8.5 hours in bed each night for at least a week before completing the second laboratory visit. There are two interventions that participants will experience during the study, sleep promoting (pink noise) and wake promoting (blue enriched lighting plus a nap). These will be delivered separately and together depending on randomization. Participants will first be randomized to one of three conditions sleep promoting + wake placebo, sleep placebo + wake promoting, or sleep promoting + wake promoting. All participants will complete a sleep placebo + wake placebo condition. The order of the full placebo condition versus the intervention (i.e., lab visit 1 vs. lab visit 2) will be randomized after the condition randomization occurs. Each participant will complete one of the interventions and one placebo for a total of two visits.

Key Dates

Start date
Jun 22, 2024
Status verified
Jul 2024
Primary completion
Jun 1, 2025
Completion
Jun 1, 2025

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: sleep promoting + wake placebo
    Participants in this condition will listen to pink noise during a sleep opportunity (sleep promoting) and then have normal light with no nap (sham/placebo).
  • Experimental: sleep placebo + wake promoting
    Participants in this condition will have a sleep opportunity with no pink noise (sham/placebo) and then be exposed to blue enriched light (wake promoting) after a nap.
  • Experimental: sleep promoting + wake promoting
    Participants in this condition will be exposed to pink noise during a sleep opportunity (sleep promoting) and then be exposed to blue enriched light (wake promoting) after a nap.

Primary Outcome Measure

Karolinska Sleepiness Scale (KSS) [ Time Frame: Up to 120 minues ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NASA Ames Research CenterMountain ViewCalifornia94043-

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NASA Ames Research Center· Mountain View, CA

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