Regulation of Emotion, Sleep Extension, and mTBI

NCT ID: NCT06883006

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2027-12-31

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.

Conditions

Mild Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sleep Extension

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sleep Extension

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Merrimack College

OTHER

Sponsor Role: lead

Responsible Party

Laura Kurdziel

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Merrimack College

North Andover, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Laura Kurdziel, PhD

Role: CONTACT

kurdziell@merrimack.edu

978-837-5361

Allison Seitchik, PhD

Role: CONTACT

seitchika@merrimack.edu

978-837-3575

Facility Contacts

Laura Kurdziel

Role: primary

kurdziell@merrimack.edu

9788373575

Allison Seitchik

Role: backup

seitchika@merrimack.edu

9788373575

Other Identifiers

1R15MH136612-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-FY18-19-196

Identifier Type: -

Identifier Source: org_study_id