Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID06531733

Sleep and Wake Countermeasures for Artemis: In-laboratory Study

Led by National Aeronautics and Space Administration (NASA) · Updated on 2024-08-01

24

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how different sleep and wake-promoting methods affect the ability to fall asleep quickly, maintain sleep during a nap, and stay alert while awake. The study focuses on testing pink noise during sleep and blue-enriched lighting combined with a nap to see if these interventions improve sleep quality and alertness. This study recruits healthy adults aged 18 to 60 and involves controlled laboratory conditions to minimize bias related to time awareness. Participants will take part in two laboratory visits spaced at least one week apart, after completing a 2-3 week at-home protocol maintaining a regular sleep schedule with at least 8.5 hours in bed each night. They will be randomly assigned to one of three groups: sleep promoting with pink noise plus wake placebo, sleep placebo plus wake promoting with blue-enriched light and a nap, or both sleep promoting and wake promoting. Each participant will experience both an intervention condition and a full placebo condition across the two visits. During each lab visit, participants will be monitored with EEG for sleep stages and quality, and undergo multiple tests including the Karolinska Sleepiness Scale (KSS) for subjective alertness, the psychomotor vigilance task (PVT) for cognitive performance, and saliva sample collection for circadian rhythm markers. Testing occurs hourly except during sleep, and participants will be observed to prevent unplanned sleep. The study includes temperature and vital sign monitoring, provides meals based on preferences, and requires participants not to drive after visits. Total lab time per visit is about 25 hours, with extensive monitoring and evaluation of sleep and alertness outcomes.

CONDITIONS

Brief Title

Artemis Sleep Countermeasures

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy individuals between the ages of 18 and 60
  • Pre-menopausal individuals must be at least six months post-partum
  • Not breastfeeding
  • Not planning pregnancy in the immediate future
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) over 30
  • Any sleep disorder
  • Chronic conditions affecting sleep or data collection (e.g., mood disorders, eye disorders, cardiovascular disease, diabetes, cancer)
  • Sensitive skin intolerant to electrode application
  • Use of medications that interfere with sleep (e.g., anti-anxiety, antihistamines, antidepressants, beta blockers)
  • Recent travel across more than two time zones or night shift work in the past month
  • Pregnancy
  • History of serious chronic conditions or mental illness (heart failure/disease, cancer, diabetes, seizures, respiratory diseases, lupus)
  • Positive toxicology for drugs of abuse including caffeine, alcohol, nicotine, amphetamines, barbiturates, benzodiazepines, cocaine, marijuana, MDMA, methadone, methamphetamines, opiates, oxycodones
  • Inability or unwillingness to maintain a regular sleep schedule with at least 8.5 hours in bed nightly for 2-3 weeks prior to study visits
  • Inability to understand and communicate in English

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Screening and enrollment visit

Treatment

Duration - Approximately 25 hours

Participants spend 25 hours in the laboratory undergoing randomized interventions including a daytime sleep opportunity with pink noise or silence, followed by a nighttime nap or quiet activities, and exposure to blue-enriched or placebo lighting. During this time, participants complete various cognitive and alertness tests and provide biological samples.

1 in-person visit lasting about 25 hours

Follow-up

Duration - Until recovery post-study

After completing the laboratory session, participants are sent home and advised to nap and avoid driving or risky activities until recovered from study-induced sleep deprivation.

No scheduled visits; recovery occurs at home

Trial Site Locations

Total: 1 location

1

NASA Ames Research Center

Mountain View, California, United States, 94043

Actively Recruiting

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Research Team

E

Erin E Flynn-Evans, PhD, MPH

N

Nicholas G Bathurst, MA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Prevalence of sleep deficiency and use of hypnotic drugs in astronauts before, during, and after spaceflight: an observational study.

Laura K Barger, Erin E Flynn-Evans, Alan Kubey...

https://pubmed.ncbi.nlm.nih.gov/25127232

Recommendations for daytime, evening, and nighttime indoor light exposure to best support physiology, sleep, and wakefulness in healthy adults.

Timothy M Brown, George C Brainard, Christian Cajochen...

https://pubmed.ncbi.nlm.nih.gov/35298459