Post Traumatic Stress Disorder PTSD
Conditions
Keywords
Stellate Ganglion Block, Sleep Profiler, PTSD, Sleep, Sleep architecture
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.
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.
Interventions
OTHERSleep 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.
Sponsors
The University of Texas Health Science Center at San Antonio
Trauma Research and Combat Casualty Care Collaborative (TRC4)
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time | Sleep onset to awakening time (approximately 8 hours) | Time spent asleep from sleep onset to waking time |
| Wake time after sleep onset | Sleep onset to awakening time (approximately 8 hours) | Percentage of time spent awake after sleep onset |
| Rapid Eye Movement (REM) sleep state | Sleep onset to awakening time (approximately 8 hours) | Percentage of sleep time spent in REM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index | Baseline to 1 month | 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 |
| Nightmare Disorder Index (NDI) | Baseline to 1 month | 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. |
| Split Week Self-Assessment of Sleep Survey (SASS-Y) for Workdays | Baseline to 1 month | 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. |
| Split Week Self-Assessment of Sleep Survey (SASS-Y) for off Days | Baseline to 1 month | 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. |
Countries
United States
Contacts
CONTACTKristi E Pruiksma, PhD, DBSM
PRINCIPAL_INVESTIGATORKristi E Pruiksma, PhD, DBSM
The University of Texas Health Science Center at San Antonio
Outcome results
None listed