RESET: Regulation of Emotion, Sleep Extension, and mTBI

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 1
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?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Merrimack College
RECRUITING
North Andover
Contact Information
Primary
Laura Kurdziel, PhD
kurdziell@merrimack.edu
978-837-5361
Backup
Allison Seitchik, PhD
seitchika@merrimack.edu
978-837-3575
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: Merrimack College

This content was sourced from clinicaltrials.gov