| NCT ID | NCT06531733 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Aeronautics and Space Administration (NASA) |
| Condition | Fatigue |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-06-22 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2024-06-22 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06531733 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Fatigue. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06531733 currently recruiting?
Yes, NCT06531733 is actively recruiting participants. Contact the research team at erin.e.flynn-evans@nasa.gov for enrollment information.
Where is the NCT06531733 trial being conducted?
This trial is being conducted at Mountain View, United States.
Who is sponsoring the NCT06531733 clinical trial?
NCT06531733 is sponsored by National Aeronautics and Space Administration (NASA). The trial plans to enroll 24 participants.