Effects of Stellate Ganglion Block and Superior Cervical Ganglion Block on Sleep and Recovery

• Conditions: PTSD
• Interventions: Procedure: stellate ganglion block (SGB)

• Registration Number: NCT05470361
• Lead Sponsor: The University of Queensland

Brief Summary

The aim of this study is to discover whether the Stellate Ganglion Block (SGB) plus the Superior Cervical Ganglion Block (SCGB) procedure is associated with improvements in heart rate variability and sleep quality as measured by the Whoop biometric capture device. It is predicted that after receiving the blocks, patients will show objectively improved measures of stress in the form of higher heart rate variability and improved sleep quality as well as improved subjective wellbeing.

Detailed Description

PTSD is meaningfully related to workforce productivity and quality of life factors, including loss of employment and decreases in general life satisfaction. Trauma leads to symptoms that diminish capacity to experience warm and loving feelings for others (emotional numbness), profound negative changes in our self-image and identity, fears that often limit enjoyment of pleasurable activities, and other life-altering challenges. Many survivors experience recurrent feelings of helplessness and horror, and may commonly experience crippling panic attacks, feelings of self-blame and shame, chronically disrupted sleep, and relationship conflict with loved ones.

Low resting Heart Rate Variability (HRV)-- the variability in the time in between heart beats--is a physiological indicator of stress and has been associated with reductions in wellbeing and increases in all-cause mortality. Higher heart rate variability is associated with better sleep quality while lower heart rate variability is associated with increased chronic inflammation. The negative effects of PTSD on sleep are well-documented, and interventions are often targeted at alleviating this damaging consequence, as insufficient sleep can perpetuate anxiety and impair day-to-day functioning, leading to an overall reduced quality of life.

The current standard of care is to offer a combination of trauma-focused psychotherapy and symptom-focused medications, typically a selective serotonin reuptake inhibitor medication. However, a promising treatment known as the Stellate Ganglion Block (SGB) plus the Superior Cervical Ganglion Block (SCGB) procedure has been shown to alleviate PTSD symptoms without any of the side-effects and barriers known to patients on conventional treatments. While this treatment shows promise, most of the research performed so far has used subjective self-report measures of sleep quality and stress. Whoop biometric capture devices offer an opportunity to objectively measure sleep quality and heart rate variability to investigate the effects of the SGB. Physiological data could reveal whether this treatment works not just to alleviate subjective stress, but to physically reduce the effects of PTSD on the body.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-06-07
• Study Start: 2022-07
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-22
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-29
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• PTSD Symptoms

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
People who suffer from PTSD	stellate ganglion block (SGB)	The sample will be composed of 30 patients from Stella's Chicago practice: 712 N Dearborn St, Chicago, Illinois 60654

Primary Outcome Measures

Name	Time	Method
Sleep Quality	8 weeks	The primary outcome measures for the study will be participant sleep scores (derived from time spent in each sleep stage) and Heart Rate Variability, both of which will be measured by a Whoop strap biometric capture device. Higher heartrate variability represents a better outcome (healthier nervous system). Likewise a higher sleep score represents a better and more complete recovery.

Secondary Outcome Measures

Name	Time	Method
Self-reported depression symptoms	8 weeks	Beck Depression Inventory-II. Scores from 0-63. Higher scores indicate more severe depression.
Self-reported Post-Traumatic Stress Disorder symptoms	8 weeks	Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorder (DSM-5). Scores range from 0-80. Higher scores mean worse Post-Traumatic Stress Disorder.