Regulation of Emotion, Sleep Extension, and mTBI

NCT06883006 | Recruiting Phase 1

• 2 other identifiers: IRB-FY18-19-1961R15MH136612-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Is a nap an effective way to improve emotion regulation in individuals with a concussion?
2. 2.Does a nap reduce the required executive resources necessary to regulate emotions in individuals with a concussion?

Conditions

Mild Traumatic Brain Injury

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Emotion Regulation (Self-report)

  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.

  Weeks 0 and 1

• Emotion Regulation (Behavioral measures)

  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.

  Weeks 0 and 1

• Executive Control over Emotions (Pupillometry)

  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.

  Weeks 0 and 1

• Executive Control over Emotions (Neurophysiology; ERP)

  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.

  Weeks 0 and 1

Secondary Outcomes (3)

• Sleep Duration and Sleep Patterns (Actigraphy)

  Weeks 0-2

• Self-report Control measures

  Weeks 0 and 1

• Self-report Control measures

  Week 0

Other Outcomes (2)

• Sleep physiology (Polysomnography)

  Weeks 0 and 1

• Sleep physiology (Polysomnography)

  Weeks 0-2

Study Arms (2)

Sleep Extension

EXPERIMENTAL

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.

Behavioral: Sleep Extension

Wake Condition

NO 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.

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.

Sleep Extension

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merrimack College: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Merrimack College

North Andover, Massachusetts, 01845-5806, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic; Emotional Regulation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Self-Control; Social Behavior; Behavior

Central Study Contacts

Laura Kurdziel, PhD

CONTACT

978-837-5361; kurdziell@merrimack.edu

Allison Seitchik, PhD

CONTACT

978-837-3575; seitchika@merrimack.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 19, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: De-identified individual-level data will be uploaded every six months, as required by NIMH, to NSRR, including after the first six months if applicable. However, primary aims data (e.g., behavioral data) will be hidden from public view until publication or one year after the end of the award period, whichever comes first.
• Access Criteria: All de-identified study data that are not designated as restricted use will be made available as public use data to the research community via NSRR. Users of the public use data must register with NSRR and agree to the Terms of Use, which state, "Access to the resources is controlled by per-dataset-access control, and access is only granted to individuals who have completed the web-based Data Access and Use Agreement (DAUA). Each DAUA submission is reviewed by the NSRR Review Committee, and reviewers ascertain that use of data appears appropriate with the intention of data collected and that there is a commitment to keep the data stored securely by the end-user. NSRR DAUAs expire 3 years from the date access is granted and can be renewed by either submitting a new request for data access or by requesting an extension of the agreement in writing to the NSRR Review Committee" (NSRR website). Data users also agree not to share or redistribute any data downloads.

Locations

US (1)