Sleep Extension for Concussion

(RESET Trial)

Overseen By Allison Seitchik, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merrimack College

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

Trial Summary

What is the purpose of this trial?

Concussions are incredibly common, and often result in severe and long lasting symptoms, including, but not limited to, sleep deprivation and emotion dysregulation. This study aims to demonstrate the therapeutic benefits of sleep extension (napping) on emotion regulation in individuals after they sustain a concussion. Thus, sleep extension may be a cost-effective, low risk, supplemental treatment for those with emotion dysregulation following a concussion. The main questions it aims to answer are: 1. Is a nap an effective way to improve emotion regulation in individuals with a concussion? 2. Does a nap reduce the required executive resources necessary to regulate emotions in individuals with a concussion?

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+