Recruiting

Stellate Ganglion Block

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT07667309

Conditions

Post Traumatic Stress Disorder PTSD

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Sleep Profiler Headband

Study Details

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

Study ID

NCT07667309

Start date

Jun 15, 2026

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Total Sleep Time [ Time Frame: Sleep onset to awakening time (approximately 8 hours) ]
  • Wake time after sleep onset [ Time Frame: Sleep onset to awakening time (approximately 8 hours) ]
  • Rapid Eye Movement (REM) sleep state [ Time Frame: Sleep onset to awakening time (approximately 8 hours) ]

Central Contacts and Locations

Central contacts

Kristi E Pruiksma, PhD, DBSM

(210) 562-6700pruiksma@uthscsa.edu

Locations

Carl R. Darnall Army Medical Center at Fort Hood

Recruiting

Killeen, Texas, United States, 76544

Contacts

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Kristi Pruiksma, PhD, DBSM

210-562-6700pruiksma@uthscsa.edu

Principal Investigator:

Kristi Pruiksma, PhD, DBSM

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • Stellate Ganglion Block
  • Sleep Profiler
  • PTSD
  • Sleep
  • Sleep architecture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-06-25.