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The Effects of Stellate Ganglion Block Sleep in U.S. Active Duty Service Members and Veterans Receiving Prolonged Exposure Therapy for PTSD
NCT07667309 · The University of Texas Health Science Center at San Antonio
In plain English
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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)
About this study
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.
Eligibility criteria
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 target: 40 participants
Age groups: adult, older_adult
Timeline
Starts: 2026-06-15
Estimated completion: 2027-06-30
Last updated: 2026-06-25
Interventions
Other: Sleep Profiler Headband
Primary outcomes
- • Total Sleep Time (Sleep onset to awakening time (approximately 8 hours))
- • Wake time after sleep onset (Sleep onset to awakening time (approximately 8 hours))
- • Rapid Eye Movement (REM) sleep state (Sleep onset to awakening time (approximately 8 hours))
Sponsor
The University of Texas Health Science Center at San Antonio · other
With: Trauma Research and Combat Casualty Care Collaborative (TRC4)
Contacts & investigators
ContactKristi E Pruiksma, PhD, DBSM · contact · pruiksma@uthscsa.edu · (210) 562-6700
InvestigatorKristi E Pruiksma, PhD, DBSM · principal_investigator, The University of Texas Health Science Center at San Antonio
All locations (2)
Carl R. Darnall Army Medical Center at Fort HoodRecruiting
Killeen, Texas, United States
University of Texas Health Science Center at San AntonioRecruiting
San Antonio, Texas, United States