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)
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Kristi E Pruiksma, PhD, DBSM
- 電話番号：(210) 562-6700
- メール：pruiksma@uthscsa.edu
研究場所
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Texas
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Killeen、Texas、アメリカ、76544
- 募集
- Carl R. Darnall Army Medical Center at Fort Hood
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コンタクト：
- Kristi E Pruiksma, PhD
- 電話番号：(210) 562-6700
- メール：pruiksma@uthscsa.edu
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コンタクト：
- Jennifer D Hein, MD
- 電話番号：254-553-9779
- メール：jennifer.m.hein6.mil@health.mil
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San Antonio、Texas、アメリカ、78229
- 募集
- University of Texas Health Science Center at San Antonio
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コンタクト：
- Kristi Pruiksma, PhD, DBSM
- 電話番号：210-562-6700
- メール：pruiksma@uthscsa.edu
-
主任研究者：
- Kristi Pruiksma, PhD, DBSM
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total Sleep Time
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Insomnia Severity Index
時間枠：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
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Baseline to 1 month
|
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Nightmare Disorder Index (NDI)
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Kristi E Pruiksma, PhD, DBSM、The University of Texas Health Science Center at San Antonio
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00002535
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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