Regulation of Emotion, Sleep Extension, and mTBI

Phase 1

Recruiting

• Conditions: Mild Traumatic Brain Injury

• Registration Number: NCT06883006
• Lead Sponsor: Merrimack College

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?

Detailed Description

The specific objective of this proposal is to determine whether sleep extension, in the form of a mid-day nap, improves emotion regulation in those with a mTBI, and to assess whether napping affects top-down neural control of emotion regulation. In order to test this, individuals with a recent (within \~1 month) mTBI (n=60) will complete an emotion regulation task after a nap (1.5 hour nap opportunity) and after a quiet wakefulness session (1.5 hour quiet waking bout). The nap will be recorded using polysomnography (PSG) to assess sleep stages and spectral analysis of sleep physiology. Emotion regulation will be assessed using a cognitive reappraisal task in which participants are asked to reduce their emotional arousal to negative images (e.g., picturing a different/happy outcome). During this task, pupillometry, eye movement behaviors (i.e., fixations and dwell times), event-related potentials (ERPs), and valence/arousal ratings will be measured. Participants will complete the task twice, one week apart, with order of the nap/no nap condition counterbalanced within gender. Thus, the investigators will have behavioral, neurophysiological, and self-report measures of emotion regulation. Sleep patterns and sleep quality data will be collected using sleep profiler headbands (to assess nocturnal sleep physiology prior to and following testing sessions), a wrist-worn actigraph and a sleep diary (to assess typical sleep patterns), polysomnography (to assess nap sleep physiology), and questionnaires. Participants will receive an actiwatch and a sleep profiler headband to wear beginning the day prior to their first laboratory session. The participant will wear the actiwatch through the day following the second session (9 days total), and will wear the sleep profiler headband on the night prior to and following each laboratory session (4 days total). Participants will also complete self-report questionnaires to report demographic information, overall sleep behaviors, current sleepiness, current positive and negative affect, and mTBI symptoms and history.

The investigators will examine the following specific aims: Aim 1: To determine the efficacy of a nap to improve emotion regulation in individuals with mTBI (n=60). Aim 2: To examine whether a nap reduces the required executive resources necessary to regulate emotions in individuals with mTBI (n=60). Exploratory Aim 1: To examine whether mid-day nap physiology correlates with emotion regulation. Exploratory Aim 2: To examine whether a mid-day nap impacts nocturnal sleep physiology.

This proposal impacts the field by seeking to shift the current clinical practice for mTBI, suggesting that naps may be a fruitful intervention for emotional symptoms and reduced sleep following mTBI. It will also be the first to examine the neurological impacts of a nap in individuals following mTBI and how it could alter emotion regulation. The findings of this R15 will be used to power a larger R01 clinical trial to examine the benefits of a multi-day nap protocol on emotion regulation in individuals with mTBI. The incorporation of naps into the therapeutic care for those with mTBI may have significant benefits to their emotional control and mental well-being. This would be a practical, cost-effective, and low risk supplemental treatment that could be used by any and all populations.

Study Timeline

• Study Start: 2025-02-01
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Study First Posted: 2025-03-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Emotion Regulation (Self-report)	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)	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Sleep Duration and Sleep Patterns (Actigraphy)	Weeks 0-2	Participants will wear an actigraph for 9 days (1 day prior to their first lab session until 1 day after their second lab session). The Actiwatch Spectrum (Philips Respironics, Inc., Bend, OR) that will be used in this study is a water-resistant, wrist-worn device with off-wrist detection and triaxial accelerometer to measure motion. Participants will wear the Actiwatch for the duration of the study. Actigraph data will be assessed for average total sleep time (TST), sleep onset variability, sleep offset variability, average sleep efficiency, detection of and variability of mid-day naps, as well as changes in nocturnal sleep duration and efficiency following a nap. Actigraphy will be used to control for variability in typical sleep behaviors, sleep quality, and sleep quantity across individuals.
Self-report Control measures	Week 0	Participants will report demographic information such as whether they have any neurological or sleep disorders and whether they are on any medications that could influence sleep and emotion regulation. These will be used as covariates.

Trial Locations

Locations (1)

Merrimack College; 🇺🇸 North Andover, Massachusetts, United States