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

NCT07667309 | Recruiting DMC

• 1 other identifier: STUDY00002535
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Post Traumatic Stress Disorder PTSD

Keywords

Stellate Ganglion Block; Sleep Profiler; PTSD; Sleep; Sleep architecture

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Insomnia Severity Index

  Baseline to 1 month

• Nightmare Disorder Index (NDI)

  Baseline to 1 month

• Split Week Self-Assessment of Sleep Survey (SASS-Y) for Workdays

  Baseline to 1 month

• Split Week Self-Assessment of Sleep Survey (SASS-Y) for off Days

  Baseline to 1 month

Study Arms (2)

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

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

Interventions

Sleep Profiler Headband OTHER

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; Massed Prolonged Exposure (PE) with SGB group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Trauma Research and Combat Casualty Care Collaborative (TRC4): collaborator
• The University of Texas Health Science Center at San Antonio: lead

Study Sites (2)

Carl R. Darnall Army Medical Center at Fort Hood

Killeen, Texas, 76544, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Kristi E Pruiksma, PhD, DBSM

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristi E Pruiksma, PhD, DBSM

CONTACT

(210) 562-6700; pruiksma@uthscsa.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 25, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study completion when data has been analyzed.

Locations

US (2)