Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT06531733

Artemis Sleep Countermeasures

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

24

Participants Needed

1

Research Sites

49 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official 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
  • Pre-menopausal individuals must not be breastfeeding
  • Pre-menopausal individuals must not be planning a pregnancy in the immediate future
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) greater than 30
  • Any sleep disorder
  • Chronic conditions that affect sleep such as mood or eye disorders
  • Chronic conditions interfering with data collection or safety such as cardiovascular disease, diabetes, or cancer
  • Sensitive skin intolerant to electrode application
  • Use of medications that interfere with sleep (e.g., anti-anxiety, antihistamines, antidepressants, beta blockers)
  • Travel across more than two time zones or night shift work in the past month
  • Pregnancy
  • History of serious chronic conditions or mental illness including heart disease, cancer, seizures, respiratory diseases, sleep disorders, or Lupus
  • Positive test for caffeine, alcohol, nicotine, or various drugs of abuse including amphetamines, barbiturates, benzodiazepines, cocaine, marijuana, MDMA, methadone, methamphetamines, opiates, oxycodones

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

N

Nicholas G Bathurst, MA

CONTACT

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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