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NCT06883006 · Merrimack College

Regulation of Emotion, Sleep Extension, and mTBI

(RESET)

What this study is about

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.

View original scientific description

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.

Interventions

BEHAVIORAL

Sleep Extension

A 1.5-hour nap opportunity compared to a neutral 1.5 hour waking activity (e.g., puzzle completion) prior to task. Participants will either nap or not 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. 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.

Primary outcome measures

Emotion Regulation (Self-report)

Time frame: Weeks 0 and 1

After viewing each image, participants will rate the valence and arousal of the image by using the Self Assessment Manikin79 (SAM). Participants will also be asked how successful they were at following the instruction to maintain or reappraise their negative affect on a 1 to 4 scale.

Emotion Regulation (Behavioral measures)

Time frame: Weeks 0 and 1

The main eye tracking behaviors will focus on the area of interest (i.e., the most emotional portion of the image). For interest areas, the investigators will examine how often participants look directly within each area of interest ("fixations") and how long they look within each area of interest ("dwell time"). The investigators will also examine the proportion of interest area fixations and dwell time relative to the trial totals.

Executive Control over Emotions (Pupillometry)

Time frame: Weeks 0 and 1

Participants' pupil dilation, which indicates cognitive control beyond sympathetic activation, will be measured. Average pupil size (area; in mm) will be compared between various conditions to determine differences in top-down control of emotion regulation.

Executive Control over Emotions (Neurophysiology; ERP)

Time frame: Weeks 0 and 1

The cap, described below, will continue to be worn during the subsequent emotion regulation task to record event related potentials (ERP). The Late Positive Potential (LPP) is an ERP most observable in the midline, and occurs approximately 300 ms after the onset of a stimulus. LPP is associated with top-down control of emotion regulation.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Between the ages of 18 and 35 years old.
  • Have normal or corrected to normal vision
  • Sustained a FIRST or SECOND concussion within the last 2-3 weeks
  • No sleep disorders
  • Is not a shift worker

Exclusion criteria

  • Under 18 or over 35 years old.
  • Not have corrected normal vision with glasses or contacts
  • Has an astigmatism in both eyes
  • Had a concussion over 3 weeks ago
  • Has sleep disorder
  • Is a shift worker

Where

  • North Andover, Massachusetts

Collaborators

National Institute of Mental Health (NIMH)

Related conditions & keywords

Mild Traumatic Brain InjuryBrain ConcussionBrain Injuries, TraumaticSleepEmotion Regulation

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Apr 9, 2025 · Source of record for eligibility and locations

📊
1 of 60 participants interested
2% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

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Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

North Andover

Massachusetts

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Mild Traumatic Brain Injury Treatment in North Andover?

Join others in Massachusetts exploring innovative treatment options through clinical research

Mild Traumatic Brain Injury Treatment Options in North Andover, Massachusetts

If you're searching for Mild Traumatic Brain Injury treatment in North Andover, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in North Andover and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Mild Traumatic Brain Injury. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Massachusetts
Now Enrolling
Up to 60 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Mild Traumatic Brain Injury?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Mild Traumatic Brain Injury

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Mild Traumatic Brain Injury Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06883006. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.