Sleep and Wake Countermeasures for Artemis: In-laboratory Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Electroencephalography (EEG)
Study Overview
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.
Detailed Description
SPECIFIC AIMS The investigators aim to test whether pink noise can improve sleep outcomes and subsequent alertness. The investigators further aim to test whether pink noise induced sleep improves alertness and performance during the night alone or in combination with blue-enriched lighting and a nap. Finally, the investigators will test whether blue-enriched lighting and a nap can improve alertness and performance during the night.
HYPOTHESES
- The investigators hypothesize that exposure to pink noise during a daytime sleep opportunity will improve sleep onset latency, sleep duration, and sleep depth compared to a control condition with no noise.
- The investigators hypothesize that sleep induced by pink noise will improve subjective alertness and performance when compared to a control condition with no noise, as measured by the Karolinska Sleepiness Scale (KSS) and psychomotor vigilance task (PVT).
- The investigators hypothesize that exposure to a blue-enriched light and a nap of up to one hour will improve subjective alertness and performance when compared to a placebo light and no nap, as measured by the Karolinska Sleepiness Scale (KSS) and psychomotor vigilance task (PVT).
- The investigators hypothesize that sleep induced by pink noise in combination with exposure to a blue-enriched light and a nap of up to one hour will improve subjective alertness and performance when compared to a control sleep condition with no noise and a placebo light and no nap, as measured by the Karolinska Sleepiness Scale (KSS) and psychomotor vigilance task (PVT).
PRIMARY OUTCOME MEASURES
- Subjective alertness as measured by the 9-point Likert-type Karolinska Sleepiness Scale (KSS).
- 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).
- 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.
STATISTICAL ANALYSES To determine the impact of the interventions compared to placebo, the investigators will use a linear mixed-effects model with fixed effects of condition (intervention, control), time (test bouts post-wake-up call), condition*time interaction, and a random effect of participant. PVT lapse data (counts) will be checked for overdispersion and, if detected, a negative binomial mixed-effects model with the same factors will be used to analyze the lapse data.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Outcomes
Primary Outcomes
Electroencephalography (EEG)
Time Frame: up to 48 hours
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.
Psychomotor Vigilance Task (PVT)
Time Frame: up to 560 minutes
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).
Karolinska Sleepiness Scale (KSS)
Time Frame: Up to 120 minues
Subjective alertness as measured by the 9-point Likert-type Karolinska Sleepiness Scale (KSS).
Secondary Outcomes
No secondary outcomes reported
Investigators
Erin E. Flynn-Evans
Fatigue Countermeasures Laboratory Director
National Aeronautics and Space Administration (NASA)