Regulation of Emotion, Sleep Extension, and mTBI

Part of paid clinical trials in North Andover, Massachusetts.

Sponsor
Merrimack College
Study ID
NCT06883006
Phase
PHASE1
Status
Recruiting
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Conditions

  • Mild Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Sleep Extension — BEHAVIORAL
    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.

Study Details

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?

Key Dates

Start date
Feb 1, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Emotion Regulation (Self-report) [ Time Frame: Weeks 0 and 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Merrimack CollegeNorth AndoverMassachusetts01845-5806
Laura Kurdziel
[email protected]
9788373575
Allison Seitchik
[email protected]
9788373575

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