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

July 27, 2022 updated by: The University of Queensland

Investigating the Effects of Stellate Ganglion Block and Superior Cervical Ganglion Block on Sleep and Recovery Using Biometric Capture Devices

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be patients who have attended the practice in Chicago, have arranged to have the SGB plus SCGB procedure to address their PTSD, and are interested in monitoring their symptoms.

Description

Inclusion Criteria:

- PTSD Symptoms

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
People who suffer from PTSD
The sample will be composed of 30 patients from Stella's Chicago practice: 712 N Dearborn St, Chicago, Illinois 60654
Procedure: stellate ganglion block (SGB)
The protocol for the SGB plus SCGB will be followed, wherein participants are given right-side procedures followed by left-side procedures on a different day if no initial improvement is seen. This procedure is carried out by injecting a local anesthetic into the neck to target the Stellate Ganglion and Superior Cervical Ganglion nerve bundles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality
Time Frame: 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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported Post-Traumatic Stress Disorder symptoms
Time Frame: 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.
8 weeks
Self-reported depression symptoms
Time Frame: 8 weeks
Beck Depression Inventory-II. Scores from 0-63. Higher scores indicate more severe depression.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Queensland

Collaborators

Whoop Inc.
Stella MSO, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

July 19, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 27, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UQueenslandSGB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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