Recruiting
Phase 1

Emotion Regulation

Sponsor:

Merrimack College

Code:

NCT06883006

Conditions

Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Interventions

Sleep Extension

Study Details

Brief summary:

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?

Conditions

Mild Traumatic Brain Injury

Study ID

NCT06883006

Start date

Feb 1, 2025

Status verified date

Apr, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Sleep Extension

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.

no intervention: Wake Condition

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.

Interventions

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 measure

  • Emotion Regulation (Self-report) [ Time Frame: Weeks 0 and 1 ]
  • Emotion Regulation (Behavioral measures) [ Time Frame: Weeks 0 and 1 ]
  • Executive Control over Emotions (Pupillometry) [ Time Frame: Weeks 0 and 1 ]
  • Executive Control over Emotions (Neurophysiology; ERP) [ Time Frame: Weeks 0 and 1 ]

Central Contacts and Locations

Central contacts

Laura Kurdziel, PhD

978-837-5361kurdziell@merrimack.edu

Allison Seitchik, PhD

978-837-3575seitchika@merrimack.edu

Locations

Merrimack College

Recruiting

North Andover, Massachusetts, United States, 01845-5806

Contacts

Laura Kurdziel

9788373575kurdziell@merrimack.edu

Allison Seitchik

9788373575seitchika@merrimack.edu

More Information

Sponsor

Merrimack College

Last update posted

Apr 9, 2025

Last verified

Apr, 2025

Keywords

  • Brain Concussion
  • Brain Injuries, Traumatic
  • Sleep
  • Emotion Regulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Merrimack College on 2025-04-09.