Artemis Sleep Countermeasures

NCT06531733 | Recruiting

• 1 other identifier: STUDY00000748
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatigue

Outcome Measures

Primary Outcomes (3)

• Karolinska Sleepiness Scale (KSS)

  Subjective alertness as measured by the 9-point Likert-type Karolinska Sleepiness Scale (KSS).

  Up to 120 minues

• Psychomotor Vigilance Task (PVT)

  Objective cognitive performance as measured by the psychomotor vigilance task (PVT), a simple reaction time task with outcome measures including number of lapses (reaction time \>500ms) and speed (1/reaction time).

  up to 560 minutes

• Electroencephalography (EEG)

  Sleep architecture as measured by electroencephalography (EEG) including sleep stage at awakening, total sleep time, time in each sleep stage, sleep efficiency, and sleep onset latency.

  up to 48 hours

Study Arms (3)

sleep promoting + wake placebo

EXPERIMENTAL

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).

Device: Sleep Promoting (pink noise); Device: Wake Promoting (blue enriched light plus a nap)

sleep placebo + wake promoting

EXPERIMENTAL

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.

Device: Sleep Promoting (pink noise); Device: Wake Promoting (blue enriched light plus a nap)

sleep promoting + wake promoting

EXPERIMENTAL

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.

Device: Sleep Promoting (pink noise); Device: Wake Promoting (blue enriched light plus a nap)

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.

sleep placebo + wake promoting; sleep promoting + wake placebo; sleep promoting + wake promoting

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.

sleep placebo + wake promoting; sleep promoting + wake placebo; sleep promoting + wake promoting

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals between the ages of 18 and 60
• Individuals who are pre-menopausal must be at least six months post-partum, not breastfeeding, and not planning a pregnancy in the immediate future.

You may not qualify if:

• BMI \> 30
• A sleep disorder of any kind
• A chronic condition that could influence sleep (e.g., mood disorders, eye disorders)
• A chronic condition that would interfere with data collection and/or potentially make sleep deprivation unsafe (e.g., cardiovascular disorders, diabetes, cancer)
• Sensitive skin that would make electrode application intolerable
• Use of medication that interferes with sleep (e.g., anti-anxiety, antihistamines, antidepressants, beta blockers)
• Travel out of the time zone or stayed up all night in the past month
• Individuals who are pregnant.
• Individuals who test positive for caffeine, alcohol, nicotine, amphetamines, barbiturates, benzodiazepines, cocaine, marijuana, MDMA (ecstasy), methadone, methamphetamines, opiates, oxycodones.

Sponsors & Collaborators

• National Aeronautics and Space Administration (NASA): lead

Study Sites (1)

NASA Ames Research Center

Mountain View, California, 94043, United States

RECRUITING

Related Publications (27)

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• Hilditch CJ, Wong LR, Bathurst NG, Feick NH, Pradhan S, Santamaria A, Shattuck NL, Flynn-Evans EE. Rise and shine: The use of polychromatic short-wavelength-enriched light to mitigate sleep inertia at night following awakening from slow-wave sleep. J Sleep Res. 2022 Oct;31(5):e13558. doi: 10.1111/jsr.13558. Epub 2022 Jan 31.

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MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Erin E Flynn-Evans, PhD, MPH

CONTACT

6502793459; erin.e.flynn-evans@nasa.gov

Nicholas G Bathurst, MA

CONTACT

6506040795; nicholas.g.bathurst@nasa.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fatigue Countermeasures Laboratory Director

Model Details: 8 participants per condition (24 total across 3 conditions + 1 sham/placebo condition that everyone will experience)

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: August 1, 2024
• Study Start: June 22, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

US (1)