Clinical trial NCT06883006: Regulation of Emotion, Sleep Extension, and mTBI
Official title: RESET: Regulation of Emotion, Sleep Extension, and mTBI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Mild Traumatic Brain Injury
Keywords: Brain Concussion
Brain Injuries, Traumatic
Sleep
Emotion Regulation
Lead sponsor: Merrimack College
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Emotion Regulation (Self-report)
timeFrame: Weeks 0 and 1
measure: Emotion Regulation (Behavioral measures)
timeFrame: Weeks 0 and 1
measure: Executive Control over Emotions (Pupillometry)
timeFrame: Weeks 0 and 1
measure: Executive Control over Emotions (Neurophysiology; ERP)
timeFrame: Weeks 0 and 1
Secondary outcomes:
measure: Sleep Duration and Sleep Patterns (Actigraphy)
timeFrame: Weeks 0-2
measure: Self-report Control measures
timeFrame: Weeks 0 and 1
measure: Self-report Control measures
timeFrame: Week 0
Other outcomes:
measure: Sleep physiology (Polysomnography)
timeFrame: Weeks 0 and 1
measure: Sleep physiology (Polysomnography)
timeFrame: Weeks 0-2
Locations:
city: North Andover
country: United States
facility: Merrimack College
state: Massachusetts
Study officials:
References: