The Effects of Stellate Ganglion Block Sleep in U.S. Active Duty Service Members and Veterans Receiving Prolonged Exposure Therapy for PTSD
18 de junio de 2026 actualizado por: Kristi Pruiksma, The University of Texas Health Science Center at San Antonio
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)
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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
40
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Kristi E Pruiksma, PhD, DBSM
- Número de teléfono: (210) 562-6700
- Correo electrónico: pruiksma@uthscsa.edu
Ubicaciones de estudio
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Texas
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Killeen, Texas, Estados Unidos, 76544
- Reclutamiento
- Carl R. Darnall Army Medical Center at Fort Hood
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Contacto:
- Kristi E Pruiksma, PhD
- Número de teléfono: (210) 562-6700
- Correo electrónico: pruiksma@uthscsa.edu
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Contacto:
- Jennifer D Hein, MD
- Número de teléfono: 254-553-9779
- Correo electrónico: jennifer.m.hein6.mil@health.mil
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San Antonio, Texas, Estados Unidos, 78229
- Reclutamiento
- University of Texas Health Science Center at San Antonio
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Contacto:
- Kristi Pruiksma, PhD, DBSM
- Número de teléfono: 210-562-6700
- Correo electrónico: pruiksma@uthscsa.edu
-
Investigador principal:
- Kristi Pruiksma, PhD, DBSM
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
1. Pre-existing skin or soft tissue condition that precludes the ability to wear the Sleep Profiler headband.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Massed Prolonged Exposure (PE) with SGB group
Participants will wear the EEG headband monitoring device (Sleep Profiler)for 3 nights as a baseline prior to SGB injection administered as part of enrollment in original study from which they were recruited.
After the SGB injection, participants will wear the headband monitoring device for 3 nights.
|
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.
|
|
Massed PE Exposure with Sham SGB
Participants will wear the EEG headband monitoring device (Sleep Profiler) for 3 nights as a baseline prior to the sham SGB injection administered as part of enrollment in original study from which they were recruited.
Participants will wear the EEG headband monitoring device for 3 nights following the sham SGB injection.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total Sleep Time
Periodo de tiempo: Sleep onset to awakening time (approximately 8 hours)
|
Time spent asleep from sleep onset to waking time
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Sleep onset to awakening time (approximately 8 hours)
|
|
Wake time after sleep onset
Periodo de tiempo: Sleep onset to awakening time (approximately 8 hours)
|
Percentage of time spent awake after sleep onset
|
Sleep onset to awakening time (approximately 8 hours)
|
|
Rapid Eye Movement (REM) sleep state
Periodo de tiempo: Sleep onset to awakening time (approximately 8 hours)
|
Percentage of sleep time spent in REM
|
Sleep onset to awakening time (approximately 8 hours)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Insomnia Severity Index
Periodo de tiempo: 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
|
Baseline to 1 month
|
|
Nightmare Disorder Index (NDI)
Periodo de tiempo: 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. |
Baseline to 1 month
|
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Split Week Self-Assessment of Sleep Survey (SASS-Y) for Workdays
Periodo de tiempo: 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.
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Baseline to 1 month
|
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Split Week Self-Assessment of Sleep Survey (SASS-Y) for off Days
Periodo de tiempo: 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.
|
Baseline to 1 month
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Kristi E Pruiksma, PhD, DBSM, The University of Texas Health Science Center at San Antonio
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de junio de 2026
Finalización primaria (Estimado)
30 de junio de 2027
Finalización del estudio (Estimado)
30 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
11 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de junio de 2026
Publicado por primera vez (Actual)
25 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
18 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00002535
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Individual participant data will not be shared, but de-identified data may be may be published in literature, discussed for educational purposes and used generally to further science.
Marco de tiempo para compartir IPD
After study completion when data has been analyzed.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .