Sleep Extension for Concussion
(RESET Trial)
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.12345
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.13467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for changes in sleep patterns and emotion regulation using actigraphy and self-report measures.
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?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merrimack College
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Citations
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 ...
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].
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 ...
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 ...
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 ( ...
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 ...
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.
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