Merrimack College
North Andover, Massachusetts, 01845-5806
Laura Kurdziel, 9788373575, kurdziell@merrimack.edu
Allison Seitchik, 9788373575, seitchika@merrimack.edu
Recruiting

Other trials in United States

About this study

Official title: RESET: Regulation of Emotion, Sleep Extension, and mTBI

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:

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

Read the 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
Being tested: Sleep Extension
Keywords: Brain Concussion, Brain Injuries, Traumatic, Sleep, Emotion Regulation
Medical subject headings: Brain Concussion, Brain Injuries, Traumatic, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sleep ExtensionBehavioural
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.

Study groups in NCT06883006
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 0 and 1

Secondary outcomes (3)

Sleep Duration and Sleep Patterns (Actigraphy)
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.
Measured: Weeks 0-2
Self-report Control measures
Participants will complete the PSQI, and the RPQ to assess sleep quantity/quality, and mTBI symptoms, respectively. They will also complete the PANAS and SSS to be used as covariates.
Measured: Weeks 0 and 1
Self-report Control measures
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.
Measured: Week 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202531 Dec 2027

First posted19 Mar 2025
Study start1 Feb 2025
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06883006
Sponsor's protocol ID: IRB-FY18-19-196
Other IDs: 1R15MH136612-01A1
Acronym: RESET
Status last verified: Apr 2025
First submitted: 12 Mar 2025
Last updated: 9 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Public use and restricted access study data and associated documentation will be made available to the research community free of charge through the Discovery Informatics Platform for Research provided by Research Information Science \& Computing (RISC) at the Brigham and Women's Hospital data repository hosted at National Sleep Research Resource (NSRR). 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.

Interested in taking part?

Laura Kurdziel, PhD

978-837-5361

kurdziell@merrimack.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Recruiting
Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome

All Mild Traumatic Brain Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RESET: Regulation of Emotion, Sleep Extension, and mTBI
ClinicalTrials.gov ID: NCT06883006
Acronym / sponsor ID: RESET / IRB-FY18-19-196
Conditions: Mild Traumatic Brain Injury
Keywords: Brain Concussion, Brain Injuries, Traumatic, Sleep, Emotion Regulation
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Merrimack CollegeUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 1 Feb 2025 (actual)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 19 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sleep Extension	Experimental	Behavioral: Sleep ExtensionA 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.
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.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sleep ExtensionA 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.	Behavioural	Sleep Extension

Primary outcome

Emotion Regulation (Self-report)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.

3 secondary outcomes

Sleep Duration and Sleep Patterns (Actigraphy)
Time frame: Weeks 0-2
Self-report Control measures
Time frame: Weeks 0 and 1
Self-report Control measures
Time frame: Week 0

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
Individual participant dataSharing planned: Yes. Public use and restricted access study data and associated documentation will be made available to the research community free of charge through the Discovery Informatics Platform for Research provided by Research Information Science \& Computing (RISC) at the Brigham and Women's Hospital data repository hosted at National Sleep Research Resource (NSRR). 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.

Related trials for Mild Traumatic Brain Injury

Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Recruiting
Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Laura Kurdziel, PhD contact

978-837-5361

kurdziell@merrimack.edu

Allison Seitchik, PhD contact

978-837-3575

seitchika@merrimack.edu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sleep Extension in people with Mild Traumatic Brain Injury, run by Merrimack College at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laura Kurdziel, PhD (978-837-5361, kurdziell@merrimack.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emotion Regulation (Self-report) (time frame: Weeks 0 and 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06883006.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.