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)
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Kristi E Pruiksma, PhD, DBSM
- 전화번호: (210) 562-6700
- 이메일: pruiksma@uthscsa.edu
연구 장소
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Texas
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Killeen, Texas, 미국, 76544
- 모병
- Carl R. Darnall Army Medical Center at Fort Hood
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연락하다:
- Kristi E Pruiksma, PhD
- 전화번호: (210) 562-6700
- 이메일: pruiksma@uthscsa.edu
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연락하다:
- Jennifer D Hein, MD
- 전화번호: 254-553-9779
- 이메일: jennifer.m.hein6.mil@health.mil
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San Antonio, Texas, 미국, 78229
- 모병
- University of Texas Health Science Center at San Antonio
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연락하다:
- Kristi Pruiksma, PhD, DBSM
- 전화번호: 210-562-6700
- 이메일: pruiksma@uthscsa.edu
-
수석 연구원:
- Kristi Pruiksma, PhD, DBSM
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total Sleep Time
기간: 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
기간: 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
기간: 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)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Insomnia Severity Index
기간: Baseline to 1 month
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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
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Baseline to 1 month
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Nightmare Disorder Index (NDI)
기간: Baseline to 1 month
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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
기간: 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
기간: 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.
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Baseline to 1 month
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kristi E Pruiksma, PhD, DBSM, The University of Texas Health Science Center at San Antonio
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00002535
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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