Post Traumatic Stress Disorder PTSDNCT07667309
The Effects of Stellate Ganglion Block Sleep in U.S. Active Duty Service Members and Veterans Receiving Prolonged Exposure Therapy for PTSD
An observational study of Post Traumatic Stress Disorder PTSD, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial summary
Participants in this study will have already been enrolled in another research study: Combining Stellate Ganglion Block with Prolonged Exposure for PTSD, NCT05889741. The investigators are using a Sleep Profiler, EEG headband to monitor a participants brainwaves while they sleep to see what effects the Stellate… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder PTSD
- What is being tested?
- Sleep Profiler Headband
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jun 2026to 30 Jun 2027
- Phase
- Observational
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Active duty and retired military service members ages 18-65 years with PTSD who are enrolled in Combining Stellate Ganglion Block With Prolonged Exposure for PTSD, NCT05889741
Who may be able to join
- Ability to provide informed consent and follow study-related instructions.
- Be randomized into the study titled "Combining Stellate Ganglion Block with Prolonged Exposure for PTSD: A Randomized Clinical Trial." NCT05889741
- Indicates willingness to wear the Sleep Profiler sleep monitor and to complete self-report assessments.
Who cannot join
- 1. Pre-existing skin or soft tissue condition that precludes the ability to wear the Sleep Profiler headband.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Carl R. Darnall Army Medical Center at Fort Hood
Killeen, Texas, 76544
Jennifer D Hein, MD, (254) 553-9779, jennifer.m.hein6.mil@health.mil
Kristi E Pruiksma, PhD, (210) 562-6700, pruiksma@uthscsa.edu
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Kristi Pruiksma, PhD, DBSM, 210-562-6700, pruiksma@uthscsa.edu
Kristi Pruiksma, PhD, DBSM
About this study
Official title: The Effects of Stellate Ganglion Block on Sleep in U.S. Active Duty Service Members and Veterans Receiving Prolonged Exposure Therapy for Posttraumatic Stress Disorder (PTSD)
Participants in this study will have already been enrolled in another research study: Combining Stellate Ganglion Block with Prolonged Exposure for PTSD, NCT05889741. The investigators are using a Sleep Profiler, EEG headband to monitor a participants brainwaves while they sleep to see what effects the Stellate Ganglion Block injection has on their sleep. Participants will wear the headband for 3 nights before the injection and then 3 nights after the injection. Participants will also complete self-report questionnaires regarding their sleep prior to the injection and following the injection. Approximately 40 participants will be included in this study. This study is a nested observational study whereby participants in the parent study who elect to participate will have their sleep assessed using the EEG headband device and self-reported sleep measures performed.
Read the detailed description
Objectives: The primary objective of this project is to observe the impact of stellate ganglion block (SGB) on objective measures of sleep (using a wearable headband) and subjective measures of sleep (self-report measures) in active duty service members and veterans receiving prolonged exposure therapy (PE) for PTSD. The secondary objective is to evaluate sleep improvements as a mechanism for PTSD treatment outcomes in this population.
Specific Aim 1: To compare the effects of a SGB with ropivacaine (active) versus a SGB with saline (sham) on objective measures of sleep macroarchitecture (i.e., rapid eye movement [REM] sleep and slow wave sleep) and sleep continuity (i.e., sleep onset latency, wake after sleep onset, number of awakenings, total sleep time, and sleep efficiency).
Specific Aim 2: To compare the effects of SGB (active)+PE versus SGB (sham)+PE on sleep microarchitectural indicators of heightened central nervous system arousal (i. e., high-frequency and low-frequency power spectral density, frequency of occipital alpha-indexed micro-arousals, slow wave features [e.g., slope, density] during N3 sleep, proportion of phasic and tonic REM sleep and REM density during REM sleep).
Specific Aim 3: Specific Aim 3: To evaluate the effects of SGB (active)+PE versus SGB (sham)+PE on self-reported measures of insomnia and nightmares.
- Conditions
- Post Traumatic Stress Disorder PTSD
- Being tested
- Sleep Profiler Headband
- Keywords
- Stellate Ganglion Block, Sleep Profiler, PTSD, Sleep, Sleep architecture
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Profiler HeadbandOther
The headband is worn for 3 nights prior to injection and then for a an additional 3 nights after the injection. Efficacy of the headband is not being tested, it is used as a measuring tool.
| Study group | Role | What they receive |
|---|---|---|
| Massed Prolonged Exposure (PE) with SGB group | Participants will wear the EEG headband monitoring device (Sleep Profiler)for 3 nights as a baseline prior to SGB injection administered as part of enrollment in original study from which they were recruited. After the SGB injection, participants will wear the headband monitoring device for 3 nights. Receives: Other: Sleep Profiler Headband | |
| Massed PE Exposure with Sham SGB | Participants will wear the EEG headband monitoring device (Sleep Profiler) for 3 nights as a baseline prior to the sham SGB injection administered as part of enrollment in original study from which they were recruited. Participants will wear the EEG headband monitoring device for 3 nights following the sham SGB injection. Receives: Other: Sleep Profiler Headband |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time
Time spent asleep from sleep onset to waking time
Measured: Sleep onset to awakening time (approximately 8 hours)
Wake time after sleep onset
Percentage of time spent awake after sleep onset
Measured: Sleep onset to awakening time (approximately 8 hours)
Rapid Eye Movement (REM) sleep state
Percentage of sleep time spent in REM
Measured: Sleep onset to awakening time (approximately 8 hours)
Secondary outcomes (4)
Insomnia Severity Index
7-item self-report measure that assesses perceived severity of insomnia. Each item uses a 4-point Likert type scale from 0 to 4. The items sum to produce a total score (range 0 - 28) with a higher score indicating
Measured: Baseline to 1 month
Nightmare Disorder Index (NDI)
The 5-item NDI evaluates for nightmare disorder in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria. Items are scored from 0-4 to give a total range between 0-20.
Higher scores on the NDI indicate greater nightmare severity.
Measured: Baseline to 1 month
Split Week Self-Assessment of Sleep Survey (SASS-Y) for Workdays
The Split Week SASS (SASS-Y) is a retrospective measure that assesses sleep parameters similar to a sleep diary including time to bed, number of awakenings, time of final awakening, and time out of bed, etc. The Split Week version asks participants to estimate these parameters based on workdays.
Measured: Baseline to 1 month
Split Week Self-Assessment of Sleep Survey (SASS-Y) for off Days
The Split Week SASS (SASS-Y) is a retrospective measure that assesses sleep parameters similar to a sleep diary including time to bed, number of awakenings, time of final awakening, and time out of bed, etc. The Split Week version asks participants to estimate these parameters based on days off of work.
Measured: Baseline to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start15 Jun 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (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 Disorder PTSDStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- Trauma Research and Combat Casualty Care Collaborative (TRC4)
- Responsible party
- Principal investigator, Kristi Pruiksma, The University of Texas Health Science Center at San Antonio
- Investigators
- Kristi E Pruiksma, PhD, DBSM, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667309
- Sponsor's protocol ID
- STUDY00002535
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will not be shared, but de-identified data may be may be published in literature, discussed for educational purposes and used generally to further science.