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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorThe University of Texas Health Science Center at San Antonio

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Sleep Profiler Headband

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Massed Prolonged Exposure (PE) with SGB group1 intervention
Group B: Massed PE Exposure with Sham SGB1 intervention

Trial outcomes

Primary outcomes

1

Total Sleep Time

Time spent asleep from sleep onset to waking time

Time frame
Sleep onset to awakening time (approximately 8 hours)
2

Wake time after sleep onset

Percentage of time spent awake after sleep onset

Time frame
Sleep onset to awakening time (approximately 8 hours)
3

Rapid Eye Movement (REM) sleep state

Percentage of sleep time spent in REM

Time frame
Sleep onset to awakening time (approximately 8 hours)

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center at San Antonio

Lead sponsor

Trauma Research and Combat Casualty Care Collaborative (TRC4)

Collaborator