Artemis Sleep Countermeasures
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Fatigue
In brief
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 facts
- Study ID
- NCT06531733
- Run by
- National Aeronautics and Space Administration (NASA)
- People needed
- 24
- Starts
- 2024-06-22
- Expected to finish
- 2025-06-01
- Last updated by the study team
- 2024-08-01
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
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 with a history of serious chronic conditions or mental illness. It is not possible to list all chronic conditions that may be exclusionary due to the number of medical conditions that would cause an individual to be ineligible. In brief, history of heart failure/disease, cancer, diabetes, seizures, respiratory diseases, sleep disorders, and Lupus are examples of conditions that would be considered exclusionary.
- Individuals who test positive for caffeine, alcohol, nicotine, amphetamines, barbiturates, benzodiazepines, cocaine, marijuana, MDMA (ecstasy), methadone, methamphetamines, opiates, oxycodones.
Where it is running
- NASA Ames Research Center — Mountain View, California, United States (enrolling)
Full record on ClinicalTrials.gov
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