Sleep Extension for Concussion

(RESET Trial)

Overseen By Allison Seitchik, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merrimack College

Disqualifiers: Astigmatism, Sleep disorder, Shift worker, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether taking a nap can help people manage emotions better after a concussion. Concussions often cause issues like trouble sleeping and controlling emotions. Participants will either take a 1.5-hour nap ("Sleep Extension") or engage in a waking activity, such as doing puzzles, to determine which is more beneficial. The trial seeks individuals who have experienced their first or second concussion in the past 2-3 weeks and do not have sleep disorders. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that sleep extension is safe for individuals with a concussion?

Research shows that better sleep can help ease symptoms after a concussion. Although no specific study has examined the safety of "sleep extension" or napping as a treatment, napping is generally safe for most people. This trial tests napping as the main treatment. So far, no negative side effects have been reported from napping alone. However, as the trial is still in its early stages, the researchers are still collecting safety information. Overall, napping is expected to be well-tolerated because it is a natural and low-risk activity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sleep Extension trial for concussions because it explores an innovative approach to recovery by focusing on sleep enhancement. Unlike typical treatments for concussions, which often involve rest and medication to manage symptoms, this trial investigates the impact of a structured nap on emotional regulation. By using a 1.5-hour nap in a controlled environment, the trial aims to uncover whether optimizing sleep can directly influence recovery outcomes. This could offer a non-pharmacological option that enhances the brain's natural healing processes, potentially leading to quicker and more effective rehabilitation strategies.

What evidence suggests that sleep extension might be an effective treatment for emotion dysregulation following a concussion?

Research has shown that sleep is important for recovery after a concussion. Some studies suggest that better sleep can help reduce symptoms like trouble sleeping and mood swings after a mild brain injury. Improving sleep in various ways has been found to alleviate these symptoms, making it a low-cost and low-risk treatment option. In this trial, participants will be assigned to different conditions to test the effects of sleep extension. One group will have a 1.5-hour nap opportunity, which might help with controlling emotions, a common challenge after a concussion. Another group will engage in a neutral waking activity, such as puzzle completion, for the same duration. By providing the brain with extra rest, the trial aims to assess whether managing emotions better following a concussion is possible. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced a concussion and are dealing with symptoms like sleep problems and difficulty managing emotions. Specific eligibility criteria details were not provided, so it's unclear who exactly can or cannot participate.

Inclusion Criteria

I had my first concussion 2-3 weeks ago.

Is not a shift worker

I do not have any sleep disorders.

Exclusion Criteria

I have a sleep disorder.

Not have corrected normal vision with glasses or contacts

Is a shift worker

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a nap or wake condition, counterbalanced within gender, with each condition lasting 1.5 hours. This is followed by an emotion regulation task.

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in sleep patterns and emotion regulation using actigraphy and self-report measures.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Extension

Trial Overview The study is testing whether taking naps (sleep extension) can help people who've had a concussion better manage their emotions. It will explore if napping reduces the mental effort needed to control emotional responses.

How Is the Trial Designed?

Group I: Sleep Extension Experimental Treatment 1 Intervention

A 1.5-hour nap opportunity compared to a neutral 1.5 hour waking activity (e.g., puzzle completion) prior to task. In this arm, participants will nap prior to the emotion regulation task. These two conditions will be counter-balanced within gender and participants will complete them 1 week apart. If they are in the nap condition, they will nap for 1.5 hours with PSG in a dark, soundproofed room with optional fan, white noise, or music.

Group II: Wake Condition Active Control 1 Intervention

A 1.5-hour nap opportunity compared to a neutral 1.5 hour waking activity (e.g., puzzle completion) prior to task. In this arm, participants will not nap prior to the emotion regulation task. These two conditions will be counter-balanced within gender and participants will complete them 1 week apart. If they are in the no nap condition, they will work on puzzles for 1.5 hours in the same room but with the lights on.

Who Is Running the Clinical Trial?

Merrimack College

Lead Sponsor

Trials

3

Recruited

150+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4824019/

Sleep, Sleep Disorders, and Mild Traumatic Brain Injury. What ... This paper presents key findings from a national working group on sleep and TBI, with a specific focus on the testing and development of sleep-related ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1087079225000255

A systematic review and meta-analysis of sleep following ... Just 2/6 studies that used non-head injury or orthopaedic injury controls reported poorer sleep quality in mTBI groups [75,95].

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03781076

NCT03781076 | Sleep After Adolescent Concussion The purpose of this research study is to learn more about how sleep changes as teens recover from concussions. We also want to learn if we can improve sleep in ...

4. liebertpub.com liebertpub.com/doi/full/10.1177/2689288X251377029

Impact of Mild Traumatic Brain Injury on Sleep Patterns in ... Importantly, some studies report that improving sleep through cognitive behavioral therapy and blue light therapy can reduce postconcussion ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5806572/

Mild Traumatic Brain Injury Chronically Impairs Sleep Specifically, chronically injured individuals report poorer sleep quality and daytime sleepiness relative to healthy controls. Objective recordings of sleep ( ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07120373

An Exploration of Sleep Disturbance and Outcomes in TBI ... This study aims to look at how sleep disturbance affects people who have had a traumatic brain injury. Sleep disturbance can include waking ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12177668/

Nightly Sleep Duration and Symptom Burden Over 1 Month ... These results suggest that nightly sleep duration was associated with increased symptom burden over the first month of concussion recovery.