RECRUITING

Artemis Sleep Countermeasures

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Sleep and Wake Countermeasures for Artemis: In-laboratory Study

Quick Facts

Study Start:2024-06-22
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06531733

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Erin E Flynn-Evans, PhD, MPH
CONTACT
6502793459
erin.e.flynn-evans@nasa.gov
Nicholas G Bathurst, MA
CONTACT
6506040795
nicholas.g.bathurst@nasa.gov

Study Locations (Sites)

NASA Ames Research Center
Mountain View, California, 94043
United States

Collaborators and Investigators

Sponsor: National Aeronautics and Space Administration (NASA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-22
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2024-06-22
Study Completion Date2025-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Fatigue