The Effects of Stellate Ganglion Block Sleep in U.S. Active Duty Service Members and Veterans Receiving Prolonged Exposure Therapy for PTSD
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)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Kristi E Pruiksma, PhD, DBSM
- Numéro de téléphone: (210) 562-6700
- E-mail: pruiksma@uthscsa.edu
Lieux d'étude
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Texas
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Killeen, Texas, États-Unis, 76544
- Recrutement
- Carl R. Darnall Army Medical Center at Fort Hood
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Contact:
- Kristi E Pruiksma, PhD
- Numéro de téléphone: (210) 562-6700
- E-mail: pruiksma@uthscsa.edu
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Contact:
- Jennifer D Hein, MD
- Numéro de téléphone: 254-553-9779
- E-mail: jennifer.m.hein6.mil@health.mil
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San Antonio, Texas, États-Unis, 78229
- Recrutement
- University of Texas Health Science Center at San Antonio
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Contact:
- Kristi Pruiksma, PhD, DBSM
- Numéro de téléphone: 210-562-6700
- E-mail: pruiksma@uthscsa.edu
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Chercheur principal:
- Kristi Pruiksma, PhD, DBSM
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
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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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total Sleep Time
Délai: Sleep onset to awakening time (approximately 8 hours)
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Time spent asleep from sleep onset to waking time
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Sleep onset to awakening time (approximately 8 hours)
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Wake time after sleep onset
Délai: Sleep onset to awakening time (approximately 8 hours)
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Percentage of time spent awake after sleep onset
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Sleep onset to awakening time (approximately 8 hours)
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Rapid Eye Movement (REM) sleep state
Délai: Sleep onset to awakening time (approximately 8 hours)
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Percentage of sleep time spent in REM
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Sleep onset to awakening time (approximately 8 hours)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Insomnia Severity Index
Délai: 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
|
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Nightmare Disorder Index (NDI)
Délai: 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
Délai: Baseline to 1 month
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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
Délai: Baseline to 1 month
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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
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Kristi E Pruiksma, PhD, DBSM, The University of Texas Health Science Center at San Antonio
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00002535
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
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