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.
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.
Study Type
OBSERVATIONAL
Enrollment
40
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.
Carl R. Darnall Army Medical Center at Fort Hood
Killeen, Texas, United States
RECRUITINGUniversity of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
RECRUITINGTotal Sleep Time
Time spent asleep from sleep onset to waking time
Time frame: Sleep onset to awakening time (approximately 8 hours)
Wake time after sleep onset
Percentage of time spent awake after sleep onset
Time frame: Sleep onset to awakening time (approximately 8 hours)
Rapid Eye Movement (REM) sleep state
Percentage of sleep time spent in REM
Time frame: Sleep onset to awakening time (approximately 8 hours)
Insomnia Severity Index
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
Time frame: Baseline to 1 month
Nightmare Disorder Index (NDI)
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.
Time frame: Baseline to 1 month
Split Week Self-Assessment of Sleep Survey (SASS-Y) for Workdays
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.
Time frame: Baseline to 1 month
Split Week Self-Assessment of Sleep Survey (SASS-Y) for off Days
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.
Time frame: Baseline to 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.