Artemis Sleep Countermeasures

NCT06531733 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-08-01

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Sleep Promoting (pink noise)

Participants will be provided with comfortable headphones to wear throughout their daytime sleep opportunity. The headphones will deliver a continuous pink noise sound no greater than 50 decibels. Participants will be allowed to turn down the sound of the pink noise if they find it too loud. Participants will wear the headphones with no noise during the placebo condition.

DEVICE

Wake Promoting (blue enriched light plus a nap)

Participants randomized to the blue-enriched light and nap condition will have the blue-enriched light turned on during their nighttime stay in the lab. The light will be turned off for up to one hour during the nap. During the placebo condition, participants will have an overhead room light of \~150 lux illuminated throughout their nighttime stay in the lab. This light level reflects an older NASA standard which was used in the design of some Artemis vehicles. During the placebo condition, participants will be asked to engage in quiet activities such as reading for one hour.

Sponsors & Collaborators

  • National Aeronautics and Space Administration (NASA)

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-22
Primary Completion
2025-06-01
Completion
2025-06-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06531733 on ClinicalTrials.gov