Post Traumatic Stress DisorderNCT06341413
Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder
A study testing SmartSleep device in people with Post Traumatic Stress Disorder, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this clinical trial is to characterize the role of sleep, emotion processing, and daily affect in post-traumatic stress disorder (PTSD) and whether improving sleep quality using slow wave activity enhancement will impact next-day affect in youth. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- SmartSleep device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All participants must meet all of the following criteria:
- Aged 14-18 years old, inclusive
- Must agree to inform the investigators within 48 hours of any emergent medical conditions and procedures
- Able to lie still on their back for up to 1 hour
- Must not be pregnant
- Must agree not to participate in any other interventional clinical trials during the duration of the study
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- Must be willing to comply with all study procedures
- Agree to have study visits video and/or audio recorded, including consent visit, clinical assessments (for staff training) and in-laboratory sleep visits (recording deleted within one month of study visit).
- A primary parent or guardian is willing participate in the study and to provide informed consent
- Are fluent in or predominantly speaking and reading in English
- In addition, PTSD and TEC youth must satisfy the following criteria:
- Must have a history of at least one traumatic event of any type, as defined by the DSM-V. This may include exposure to physical or sexual abuse, witnessing violence against loved ones or friends, traumatic accidents, natural disasters, death of a close family member etc.
- Additional criteria for PTSD youth:
- At baseline, meet threshold for DSM-5 criteria for current severe PTSD, as determined by the semi-structured clinical interview (KSADS).
Who cannot join
- Caregiver or adolescent is unwilling or unable to give adequate informed consent.
- Are likely, in the investigator's opinion and via observation during the screening and clinical assessment period, to be re-exposed to their index trauma or other significant trauma, lack social support, or lack a stable living situation during study participation.
- Any finding(s), based on the screening process, that the PI feels would make the study unsuitable for the participant.
- Participation in the last 30 days in a clinical study involving an investigational drug
- MRI contraindication
- Claustrophobia or inability lie still in the scanner after practice MRI sessions.
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- Any participant presenting current serious suicide risk, as determined through the KSADS, responses to C-SSRS, and/or clinical judgment of the investigator, will be excluded; however, history of suicide attempts is not an exclusion. Would present a serious risk to others as established through clinical interview and contact with treating physician.
- Neurodevelopmental disorders such as autism spectrum disorder
- Intellectual Disability (IQ less than 70, per self-report)
- Currently impaired by any medical condition that would prevent study participation
- Traumatic brain injury with ongoing symptoms, including headache, visual disturbances, and/or impairments in concentration.
- Neurological disorder(s) such as seizures, epilepsy, or brain tumors (Tourette's disorder, as diagnosed in the KSADS, is not exclusionary for TEC/PTSD youth)
- Current use of medications or other drugs (i.e., alcohol) in a manner that may interfere with sleep.
- Possible pregnancy
- Exclusions for Typically developing youth:
- No history of or current psychopathology, as defined in the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS), with exception of past specific phobia and past, resolved episodes of depressive or anxiety disorders. Provided that:
- The episode is not current (i.e. does not meet current criteria as assessed by the KSADS),
- The participant is not currently receiving psychiatric treatment (medication or psychotherapy) for mood/anxiety, and
- There is no current serious suicide risk (per KSADS/C-SSRS).
- Current diagnosis of a sleep disorder (self-report).
- Any history of any traumatic experience as defined by the DSM-V, including IPV exposure, neglect, or emotional abuse etc.
- PTSD Youth:
- Current diagnosis of or history of psychotic disorder, bipolar disorder, or autism spectrum disorder diagnosed by the KSADS interview. No other co-morbid disorders are exclusionary.
- TEC Youth:
- A current diagnosis of PTSD or a current diagnosis of or history of psychotic disorder, bipolar disorder, or autism spectrum disorder diagnosed by the KSADS interview.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53705
Sara Heyn, JD, PhD, 303-296-2116, sheyn@wisc.edu
Stephanie Jones, MD, PhD
About this study
Official title: Sleep and Emotion Processing in Adolescent Post-Traumatic Stress Disorder
The goal of this clinical trial is to characterize the role of sleep, emotion processing, and daily affect in post-traumatic stress disorder (PTSD) and whether improving sleep quality using slow wave activity enhancement will impact next-day affect in youth.
Participants will attend 4 study visits:
- A clinical and trauma assessment visit
- A testing day that may include cognitive testing, surveys, and an MRI.
- An overnight sleep study following one week of at-home sleep recordings with the device in the sham condition
- An overnight sleep study following one week of at-home sleep recordings with the device in the sleep enhancement condition
Read the detailed description
In this study, researchers aim to characterize sleep and explore its relationship to emotion processing and daily affect in 165 youth spilt into 3 groups. Researchers will use advanced sleep assessment methodologies including: (1) high-density EEG (256 channels) in the laboratory to explore the regional distribution of sleep before and after an emotional learning task and; (2) a sleep-wearable EEG recording headband, SmartSleep, to record sleep longitudinally at home. Using SmartSleep's sleep enhancement algorithms, researchers will determine whether the deepest sleep, slow-wave activity (SWA) of non-rapid eye-movement (NREM) sleep, can be reliably increased in all youth.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- SmartSleep device
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartSleep deviceDevice
Device worn during sleep
| Study group | Role | What they receive |
|---|---|---|
| Stimulation mode first | Experimental | During one week, the SmartSleep device will be set to stimulation mode. Receives: Device: SmartSleep device |
| Sham mode first | Sham comparator | During one week, the SmartSleep device will be set to sham. Receives: Device: SmartSleep device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotional Regulation - arousal
Participants will view 140 target stimuli - 70 negative and 70 neutral- in pseudorandom order. The Self-Assessment Manikin Scale for Arousal 142 (SAM) appears after the target image and participants are asked to rate degree of emotional arousal experienced while processing the picture by pressing one of nine response buttons (ranging from 1 = very low to 9 = very high).
Measured: First overnight session to second overnight, up to 5 weeks
Change in Emotional Regulation - recall
Participants complete a recognition phase. In this phase, 200 neutral and negative images are viewed. This set includes the 140 previously viewed images intermixed with 70 novel images (50% negative and 50% neutral). Participants are asked to assess arousal using the SAM (degree of emotional arousal experienced while processing the picture by pressing one of nine response buttons (ranging from 1 = very low to 9 = very high)), and to indicate whether or not they recognize pictures from the previous encoding session (''old'') or not (''new'') by pressing one of two response buttons.
Measured: First overnight session to second overnight, up to 5 weeks
Change in Slow-wave Activity (SWA)
Measured by overnight high-density EEG
Measured: First overnight session to second overnight, up to 5 weeks
Secondary outcomes (1)
Change in Positive and Negative Affect Schedule (PANAS)
PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50.
Measured: First week at-home recordings to second week, up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start16 Jul 2024
- Primary completion1 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Stephanie Jones, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341413
- Sponsor's protocol ID
- 2023-1281
- Other IDs
- A539500, SMPH/SLEEP CENTER/SLEEP CTR, Protocol Approved 3/9/2026, 1R01MH132221
- Status last verified
- Jul 2026
- First submitted
- 26 Mar 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Emotion Processing in Adolescent Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT06341413
- Acronym / sponsor ID
- 2023-1281
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Apr 2024 (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.
The goal of this clinical trial is to characterize the role of sleep, emotion processing, and daily affect in post-traumatic stress disorder (PTSD) and whether improving sleep quality using slow wave activity enhancement will impact next-day affect in youth.
Participants will attend 4 study visits:
- A clinical and trauma assessment visit
- A testing day that may include cognitive testing, surveys, and an MRI.
- An overnight sleep study following one week of at-home sleep recordings with the device in the sham condition
- An overnight sleep study following one week of at-home sleep recordings with the device in the sleep enhancement condition
Detailed description
In this study, researchers aim to characterize sleep and explore its relationship to emotion processing and daily affect in 165 youth spilt into 3 groups. Researchers will use advanced sleep assessment methodologies including: (1) high-density EEG (256 channels) in the laboratory to explore the regional distribution of sleep before and after an emotional learning task and; (2) a sleep-wearable EEG recording headband, SmartSleep, to record sleep longitudinally at home. Using SmartSleep's sleep enhancement algorithms, researchers will determine whether the deepest sleep, slow-wave activity (SWA) of non-rapid eye-movement (NREM) sleep, can be reliably increased in all youth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation mode first | Experimental | Device: SmartSleep deviceDuring one week, the SmartSleep device will be set to stimulation mode. |
| Sham mode first | Sham comparator | Device: SmartSleep deviceDuring one week, the SmartSleep device will be set to sham. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Aged 14-18 years old, inclusive
- Must agree to inform the investigators within 48 hours of any emergent medical conditions and procedures
- Able to lie still on their back for up to 1 hour
- Must not be pregnant
- Must agree not to participate in any other interventional clinical trials during the duration of the study
Key exclusion criteria (25 listed)
- Caregiver or adolescent is unwilling or unable to give adequate informed consent.
- Are likely, in the investigator's opinion and via observation during the screening and clinical assessment period, to be re-exposed to their index trauma or other significant trauma, lack social support, or lack a stable living situation during study participation.
- Any finding(s), based on the screening process, that the PI feels would make the study unsuitable for the participant.
- Participation in the last 30 days in a clinical study involving an investigational drug
- MRI contraindication
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 |
|---|---|---|
| SmartSleep deviceDevice worn during sleep | Device | Sham mode first, Stimulation mode first |
Primary outcome
Change in Emotional Regulation - arousal
Time frame: First overnight session to second overnight, up to 5 weeks
Participants will view 140 target stimuli - 70 negative and 70 neutral- in pseudorandom order. The Self-Assessment Manikin Scale for Arousal 142 (SAM) appears after the target image and participants are asked to rate degree of emotional arousal experienced while processing the picture by pressing one of nine response buttons (ranging from 1 = very low to 9 = very high).
Change in Emotional Regulation - recall
Time frame: First overnight session to second overnight, up to 5 weeks
Participants complete a recognition phase. In this phase, 200 neutral and negative images are viewed. This set includes the 140 previously viewed images intermixed with 70 novel images (50% negative and 50% neutral). Participants are asked to assess arousal using the SAM (degree of emotional arousal experienced while processing the picture by pressing one of nine response buttons (ranging from 1 = very low to 9 = very high)), and to indicate whether or not they recognize pictures from the previous encoding session (''old'') or not (''new'') by pressing one of two response buttons.
Change in Slow-wave Activity (SWA)
Time frame: First overnight session to second overnight, up to 5 weeks
Measured by overnight high-density EEG
1 secondary outcome
Change in Positive and Negative Affect Schedule (PANAS)
Time frame: First week at-home recordings to second week, up to 6 weeks
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 15 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Stephanie Jones, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartSleep device in people with Post Traumatic Stress Disorder, run by University of Wisconsin, Madison 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 14 inclusion and 25 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 15 Jul 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Sara Heyn, JD, PhD (303-296-2116, sheyn@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Emotional Regulation - arousal (time frame: First overnight session to second overnight, up to 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2026.