Sleep and Wake Interventions for Fatigue

(ASCM Trial)

Overseen By Nicholas G Bathurst, MA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: National Aeronautics and Space Administration (NASA)

Must not be taking: Anti-anxiety, Antihistamines, Antidepressants, others

Disqualifiers: Sleep disorders, Mood disorders, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not use medications that interfere with sleep, such as anti-anxiety drugs, antihistamines, antidepressants, and beta blockers. If you are taking any of these, you may need to stop them to participate.

What data supports the effectiveness of the treatment Artemis Sleep Countermeasures for fatigue?

The research highlights that fatigue and sleepiness are distinct but related issues, often seen in conditions like chronic fatigue syndrome and multiple sclerosis. While the studies do not directly address Artemis Sleep Countermeasures, they suggest that addressing sleep disorders and improving sleep quality could potentially help manage fatigue, as sleep issues can contribute to fatigue. ^{1 2 3 4 5}

Is the Artemis Sleep Countermeasures treatment safe for humans?

The research articles provided do not contain specific safety data for Artemis Sleep Countermeasures or similar treatments. However, they discuss the use of smartphone apps and tests for managing sleep and fatigue, which are generally non-invasive and safe for human use. ^{6 7 8 9 10}

How does the Artemis Sleep Countermeasures treatment differ from other treatments for fatigue?

The Artemis Sleep Countermeasures treatment is unique because it likely involves a combination of sleep and wake interventions tailored to manage fatigue, potentially using innovative tools like the 2B-Alert App, which provides real-time, personalized predictions of alertness based on individual responses to sleep deprivation. This approach may offer a more personalized and adaptive strategy compared to standard treatments that often rely on general wake-promoting substances. ^{6 8 11 12 13}

What is the purpose of this trial?

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

This trial is for individuals experiencing fatigue who can maintain a regular sleep schedule with at least 8.5 hours in bed for weeks before lab visits. They must complete pre-trial screening and protocols, but those with certain conditions that could interfere are excluded.

Inclusion Criteria

I am pre-menopausal, not pregnant or breastfeeding, and not planning to become pregnant soon.

Exclusion Criteria

BMI > 30

I have a sleep disorder.

I have not traveled across time zones or stayed up all night in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

At-home protocol

At-home Protocol

Participants maintain a regular sleep schedule with at least 8.5 hours in bed each night

1-2 weeks

Laboratory Visit 1

Participants undergo interventions with either sleep promoting or wake promoting conditions

25 hours

1 visit (in-person)

Laboratory Visit 2

Participants undergo the second set of interventions with randomized conditions

25 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the laboratory visits

1 week

Treatment Details

Interventions

• Artemis Sleep Countermeasures

Trial Overview The study tests the effectiveness of pink noise to promote sleep and blue enriched light plus a nap to enhance wakefulness. Participants will experience these interventions separately or together across two lab visits, following random assignment to different conditions.

Participant Groups

Group I: sleep promoting + wake promoting Experimental Treatment 2 Interventions

Participants in this condition will be exposed to pink noise during a sleep opportunity (sleep promoting) and then be exposed to blue enriched light (wake promoting) after a nap.

Group II: sleep promoting + wake placebo Experimental Treatment 2 Interventions

Participants in this condition will listen to pink noise during a sleep opportunity (sleep promoting) and then have normal light with no nap (sham/placebo).

Group III: sleep placebo + wake promoting Experimental Treatment 2 Interventions

Participants in this condition will have a sleep opportunity with no pink noise (sham/placebo) and then be exposed to blue enriched light (wake promoting) after a nap.

Who Is Running the Clinical Trial?

National Aeronautics and Space Administration (NASA)

Lead Sponsor

Trials

32

Recruited

1,900+

Findings from Research

Patients with chronic fatigue syndrome (CFS) experience significant sleep abnormalities, including longer time spent in bed but lower sleep efficiency compared to healthy controls, which may contribute to their daytime fatigue.

Out of 12 CFS patients, 7 were found to have sleep disorders, indicating a strong link between sleep issues and the severity of functional impairment in these patients, suggesting that addressing sleep disorders could be crucial in managing CFS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abnormalities of sleep in patients with the chronic fatigue syndrome. Morriss, R., Sharpe, M., Sharpley, AL., et al.[2019]

A systematic review of 48 studies found that while daytime sleepiness is present in multiple sclerosis (MS) patients, it is less prevalent and severe than fatigue, but still significant enough to warrant attention.

There is a moderate association between daytime sleepiness, measured by the Epworth Sleepiness Scale, and fatigue rating scales, indicating that sleep disorders may contribute to fatigue in MS and should be considered in patient assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daytime sleepiness versus fatigue in patients with multiple sclerosis: A systematic review on the Epworth sleepiness scale as an assessment tool. Popp, RF., Fierlbeck, AK., Knüttel, H., et al.[2018]

Sleepiness and fatigue are distinct but often confused phenomena, with sleepiness linked to impaired arousal mechanisms and fatigue being a more complex and subjective experience.

There is currently no consensus on the definitions or measurement tools for sleepiness and fatigue, leading to challenges in accurately assessing and treating these common symptoms in various medical and psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distinguishing sleepiness and fatigue: focus on definition and measurement. Shen, J., Barbera, J., Shapiro, CM.[2022]

The study successfully developed two distinct scales to measure sleepiness and fatigue, demonstrating that these two concepts can be empirically separated, which is important for accurate assessment in clinical settings.

The new Empirical Sleepiness Scale focuses on daytime sleep tendency, while the Empirical Fatigue Scale is linked to broader issues like insomnia and psychological health, helping to identify specific conditions like sleep apnea that can be effectively treated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief and distinct empirical sleepiness and fatigue scales. Bailes, S., Libman, E., Baltzan, M., et al.[2015]

In a study of 20 monozygotic twin pairs, those with chronic fatigue syndrome (CFS) reported significantly higher levels of subjective sleepiness compared to their healthy twins, as measured by the Epworth Sleepiness Scale and Stanford Sleepiness Scales.

Despite the increased feelings of sleepiness, there was no significant difference in objective sleep latency between CFS and healthy twins, suggesting that individuals with CFS may confuse their chronic fatigue with sleepiness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subjective and objective sleepiness in monozygotic twins discordant for chronic fatigue syndrome. Watson, NF., Jacobsen, C., Goldberg, J., et al.[2019]

The psychomotor vigilance test (PVT) is a reliable and easy-to-administer measure of vigilance that is sensitive to sleep loss, making it a useful tool for assessing fatigue in healthy adults.

While the multiple sleep latency test (MSLT) and maintenance of wakefulness test (MWT) are more sensitive to acute total sleep deprivation, all three tests (PVT, MSLT, MWT) show similar sensitivity to multiple days of sleep restriction, indicating that the PVT can effectively contribute to fatigue risk management systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying the effects of sleep loss: relative effect sizes of the psychomotor vigilance test, multiple sleep latency test, and maintenance of wakefulness test. Chaisilprungraung, T., Stekl, EK., Thomas, CL., et al.[2023]

In a study of 632 participants (261 women and 371 men) with an average age of 50.8 years, higher scores on the Epworth Sleepiness Scale (ESS) were linked to a significantly increased risk of falling asleep during the Multiple Sleep Latency Test (MSLT), indicating a strong association between subjective sleepiness and objective sleep tendency.

A clear dose-response relationship was found between self-reported nighttime sleep duration and daytime sleep tendency, with those getting less sleep showing a much higher risk of sleep onset during the MSLT, suggesting that both subjective sleep reports and actual sleep duration are important indicators of daytime sleepiness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of objective sleep tendency in the general population. Punjabi, NM., Bandeen-Roche, K., Young, T.[2019]

The 2B-Alert App is a groundbreaking mobile application that learns an individual's response to sleep deprivation in real time, providing personalized predictions of alertness based on a Bayesian learning algorithm and psychomotor vigilance tests.

In a study involving 21 participants over 62 hours of total sleep deprivation, the app demonstrated high accuracy in predicting alertness, achieving peak prediction accuracy after just 12 tests, which can help users manage fatigue effectively in various settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2B-Alert App: A mobile application for real-time individualized prediction of alertness. Reifman, J., Ramakrishnan, S., Liu, J., et al.[2020]

A study of 44 airline pilots over 34 days revealed that sleep duration decreased during early starts and late finishes, highlighting the impact of flight schedules on sleep quality.

The research demonstrated that pilots' performance was significantly impaired during early, high-workload, and late flights, indicating that circadian misalignment and sleep loss can negatively affect operational safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collecting Sleep, Circadian, Fatigue, and Performance Data in Complex Operational Environments. Arsintescu, L., Kato, KH., Hilditch, CJ., et al.[2020]

A significant portion of adults in the US experience sleep deficiency, with 50-70 million affected by sleep disorders, which can negatively impact health and workplace productivity.

The dayzz app, a personalized sleep training program, will be tested in a randomized trial to assess its effectiveness in improving sleep quality and employee performance, potentially offering a scalable solution for sleep health education and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical trial to evaluate the dayzz smartphone app on employee sleep, health, and productivity at a large US employer. Robbins, R., Weaver, MD., Quan, SF., et al.[2023]

In a 22-week study involving 225 short-sleeping adults, a digitally delivered incentive program showed short-term improvements in sleep duration and reduced morning sleepiness, particularly in the Goal-Setting group who received health vouchers for meeting sleep goals.

While the Goal-Setting group experienced a slight increase in time-in-bed and earlier bedtimes during the initial weeks, the overall sleep outcomes did not differ significantly from the Control group, suggesting that more structural changes may be needed to achieve lasting improvements in sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized-controlled trial of a digital, small incentive-based intervention for working adults with short sleep. Ong, JL., Massar, SAA., Lau, T., et al.[2023]

The NASA Ames Fatigue Countermeasures Program aims to tackle the challenges of sleep loss and circadian disruption caused by nonstandard work schedules in aviation, which can lead to fatigue and decreased performance.

The program highlights the importance of addressing these issues to improve safety and productivity in 24-hour operations, suggesting a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatigue in operational settings: examples from the aviation environment. Rosekind, MR., Gander, PH., Miller, DL., et al.[2017]

Sleep deprivation has serious effects on health and performance, making it essential for individuals to prioritize getting enough quality sleep based on their personal needs.

For those unable to achieve adequate sleep due to medical conditions or work demands, wake-promoting medications like caffeine and modafinil can help manage excessive daytime sleepiness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Countermeasures for sleep loss and deprivation. Kushida, CA.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Abnormalities of sleep in patients with the chronic fatigue syndrome. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Daytime sleepiness versus fatigue in patients with multiple sclerosis: A systematic review on the Epworth sleepiness scale as an assessment tool. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Distinguishing sleepiness and fatigue: focus on definition and measurement. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Brief and distinct empirical sleepiness and fatigue scales. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Subjective and objective sleepiness in monozygotic twins discordant for chronic fatigue syndrome. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Quantifying the effects of sleep loss: relative effect sizes of the psychomotor vigilance test, multiple sleep latency test, and maintenance of wakefulness test. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Predictors of objective sleep tendency in the general population. [2019]

8. England pubmed.ncbi.nlm.nih.gov

2B-Alert App: A mobile application for real-time individualized prediction of alertness. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Collecting Sleep, Circadian, Fatigue, and Performance Data in Complex Operational Environments. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

A clinical trial to evaluate the dayzz smartphone app on employee sleep, health, and productivity at a large US employer. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

A randomized-controlled trial of a digital, small incentive-based intervention for working adults with short sleep. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Fatigue in operational settings: examples from the aviation environment. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

Countermeasures for sleep loss and deprivation. [2020]