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

Part of paid clinical trials in Killeen, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT07667309
Status
Recruiting
Apply to this trial

Conditions

  • Post Traumatic Stress Disorder PTSD

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Total Sleep Time [ Time Frame: Sleep onset to awakening time (approximately 8 hours) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Carl R. Darnall Army Medical Center at Fort HoodKilleenTexas76544
Jennifer D Hein, MD
[email protected]
254-553-9779
Kristi E Pruiksma, PhD
[email protected]
(210) 562-6700
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Kristi Pruiksma, PhD, DBSM
[email protected]
210-562-6700
Kristi Pruiksma, PhD, DBSM (PRINCIPAL_INVESTIGATOR)

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By research site
Carl R. Darnall Army Medical Center at Fort Hood· Killeen, TXUniversity of Texas Health Science Center at San Antonio· San Antonio, TX

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