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Behavioural Intervention

Sleep and Wake Interventions for Fatigue (ASCM Trial)

N/A

Recruiting

Research Sponsored by National Aeronautics and Space Administration (NASA)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy individuals between the ages of 18 and 60

Be between 18 and 65 years old

Must not have

A sleep disorder of any kind

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 560 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test different methods to help improve sleep and alertness in individuals. Participants will have to follow a specific sleep schedule at home before two laboratory visits. They will experience different interventions like pink

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly mentioned, but participants may experience discomfort from changes in their sleep patterns due to the interventions or placebo conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 60 years old and healthy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a sleep disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 560 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 560 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 560 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Electroencephalography (EEG)

Karolinska Sleepiness Scale (KSS)

Psychomotor Vigilance Task (PVT)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: sleep promoting + wake promotingExperimental Treatment2 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 placeboExperimental Treatment2 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 promotingExperimental Treatment2 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.

0 / 2Eligibility criteria met