The Effects of Stellate Ganglion Block Sleep in U.S. Active Duty Service Members and Veterans Receiving Prolonged Exposure Therapy for PTSD

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.

Study Overview

• Status: Recruiting
• Conditions: Post Traumatic Stress Disorder PTSD
• Intervention / Treatment: Other: Sleep Profiler Headband

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Kristi E Pruiksma, PhD, DBSM; Phone Number: (210) 562-6700; Email: pruiksma@uthscsa.edu

Study Locations

• United States
  • Texas
    • Killeen, Texas, United States, 76544
      • Recruiting
      • Carl R. Darnall Army Medical Center at Fort Hood
      • Contact: Kristi E Pruiksma, PhD; Phone Number: (210) 562-6700; Email: pruiksma@uthscsa.edu
      • Contact: Jennifer D Hein, MD; Phone Number: 254-553-9779; Email: jennifer.m.hein6.mil@health.mil
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Health Science Center at San Antonio
      • Contact: Kristi Pruiksma, PhD, DBSM; Phone Number: 210-562-6700; Email: pruiksma@uthscsa.edu
      • Principal Investigator: Kristi Pruiksma, PhD, DBSM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

1. Ability to provide informed consent and follow study-related instructions.
2. Be randomized into the study titled "Combining Stellate Ganglion Block with Prolonged Exposure for PTSD: A Randomized Clinical Trial." NCT05889741
3. Indicates willingness to wear the Sleep Profiler sleep monitor and to complete self-report assessments.

Exclusion Criteria:

1. Pre-existing skin or soft tissue condition that precludes the ability to wear the Sleep Profiler headband.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Sleep Profiler Headband; 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.
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.	Other: Sleep Profiler Headband; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Sleep Time	Time spent asleep from sleep onset to waking time	Sleep onset to awakening time (approximately 8 hours)
Wake time after sleep onset	Percentage of time spent awake after sleep onset	Sleep onset to awakening time (approximately 8 hours)
Rapid Eye Movement (REM) sleep state	Percentage of sleep time spent in REM	Sleep onset to awakening time (approximately 8 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	Baseline to 1 month

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: Trauma Research and Combat Casualty Care Collaborative (TRC4)
• Investigators: Principal Investigator: Kristi E Pruiksma, PhD, DBSM, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; Sleep; Sleep architecture; Stellate Ganglion Block; Sleep Profiler
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Combat Disorders
• Other Study ID Numbers: STUDY00002535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: After study completion when data has been analyzed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No