About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to provide informed consent and follow study-related instructions.
Be randomized into the study titled "Combining Stellate Ganglion Block with Prolonged Exposure for PTSD: A Randomized Clinical Trial." NCT05889741
Indicates willingness to wear the Sleep Profiler sleep monitor and to complete self-report assessments.
Disqualifiers
None
Trial population
Active duty and retired military service members ages 18-65 years with PTSD who are enrolled in Combining Stellate Ganglion Block With Prolonged Exposure for PTSD, NCT05889741
Trial design
Other
Prospective
Treatments tested in this trial
Sleep Profiler Headband
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Total Sleep Time
Time spent asleep from sleep onset to waking time
Wake time after sleep onset
Percentage of time spent awake after sleep onset
Rapid Eye Movement (REM) sleep state
Percentage of sleep time spent in REM
Secondary outcomes
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
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.
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.
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.
Sponsors and contacts
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The University of Texas Health Science Center at San Antonio
Lead sponsor
Trauma Research and Combat Casualty Care Collaborative (TRC4)
Collaborator