PTSDNCT05470361
Effects of Stellate Ganglion Block and Superior Cervical Ganglion Block on Sleep and Recovery
An observational study of PTSD, run by The University of Queensland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- PTSD
- What is being tested?
- stellate ganglion block (SGB)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- PTSD Symptoms
Who cannot join
- none
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- PTSD
- Being tested
- stellate ganglion block (SGB)
- Keywords
- PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stellate ganglion block (SGB)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: stellate ganglion block (SGB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
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.
Measured: 8 weeks
Secondary outcomes (2)
Self-reported Post-Traumatic Stress Disorder symptoms
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.
Measured: 8 weeks
Self-reported depression symptoms
Beck Depression Inventory-II. Scores from 0-63. Higher scores indicate more severe depression.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Whoop Inc., Stella MSO, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470361
- Sponsor's protocol ID
- UQueenslandSGB
- Status last verified
- May 2022
- First submitted
- 7 Jun 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alkire, M. T., Hollifield, M., Khoshsar, R., Nguyen, L., Alley, S. R., & Reist, C. (2015, October). Neuroimaging suggests that stellate ganglion block improves post-traumatic stress disorder (PTSD) through an amygdala mediated mechanism. In The Anesthesiology Annual Meeting.
Alvaro PK, Roberts RM, Harris JK. A Systematic Review Assessing Bidirectionality between Sleep Disturbances, Anxiety, and Depression. Sleep. 2013 Jul 1;36(7):1059-1068. doi: 10.5665/sleep.2810.
PubMed 23814343Bernardy NC, Friedman MJ. Psychopharmacological strategies in the management of posttraumatic stress disorder (PTSD): what have we learned? Curr Psychiatry Rep. 2015 Apr;17(4):564. doi: 10.1007/s11920-015-0564-2.
PubMed 25749751Feeny NC, Zoellner LA, Fitzgibbons LA, Foa EB. Exploring the roles of emotional numbing, depression, and dissociation in PTSD. J Trauma Stress. 2000 Jul;13(3):489-98. doi: 10.1023/A:1007789409330.
PubMed 10948488Filipas HH, Ullman SE. Child sexual abuse, coping responses, self-blame, posttraumatic stress disorder, and adult sexual revictimization. J Interpers Violence. 2006 May;21(5):652-72. doi: 10.1177/0886260506286879.
PubMed 16574638Kim HG, Cheon EJ, Bai DS, Lee YH, Koo BH. Stress and Heart Rate Variability: A Meta-Analysis and Review of the Literature. Psychiatry Investig. 2018 Mar;15(3):235-245. doi: 10.30773/pi.2017.08.17. Epub 2018 Feb 28.
PubMed 29486547Lipov EG, Joshi JR, Lipov S, Sanders SE, Siroko MK. Cervical sympathetic blockade in a patient with post-traumatic stress disorder: a case report. Ann Clin Psychiatry. 2008 Oct-Dec;20(4):227-8. doi: 10.1080/10401230802435518. No abstract available.
PubMed 19034755Lynch JH, Mulvaney SW, Kim EH, de Leeuw JB, Schroeder MJ, Kane SF. Effect of Stellate Ganglion Block on Specific Symptom Clusters for Treatment of Post-Traumatic Stress Disorder. Mil Med. 2016 Sep;181(9):1135-41. doi: 10.7205/MILMED-D-15-00518.
PubMed 27612365Miller JV, Andre Q, Timmers I, Simons L, Rasic N, Lebel C, Noel M. Subclinical post-traumatic stress symptomology and brain structure in youth with chronic headaches. Neuroimage Clin. 2021;30:102627. doi: 10.1016/j.nicl.2021.102627. Epub 2021 Mar 13.
PubMed 33812302Muldoon OT, Lowe RD, Jetten J, Cruwys T, Haslam SA. Personal and Political: Post-Traumatic Stress Through the Lens of Social Identity, Power, and Politics. Polit Psychol. 2021 Jun;42(3):501-533. doi: 10.1111/pops.12709. Epub 2020 Dec 13.
PubMed 34219849Mulvaney SW, Lynch JH, Hickey MJ, Rahman-Rawlins T, Schroeder M, Kane S, Lipov E. Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. Mil Med. 2014 Oct;179(10):1133-40. doi: 10.7205/MILMED-D-14-00151.
PubMed 25269132Rae Olmsted KL, Bartoszek M, Mulvaney S, McLean B, Turabi A, Young R, Kim E, Vandermaas-Peeler R, Morgan JK, Constantinescu O, Kane S, Nguyen C, Hirsch S, Munoz B, Wallace D, Croxford J, Lynch JH, White R, Walters BB. Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):130-138. doi: 10.1001/jamapsychiatry.2019.3474.
PubMed 31693083Rauch SA, Eftekhari A, Ruzek JI. Review of exposure therapy: a gold standard for PTSD treatment. J Rehabil Res Dev. 2012;49(5):679-87. doi: 10.1682/jrrd.2011.08.0152.
PubMed 23015579Ross RJ, Ball WA, Dinges DF, Kribbs NB, Morrison AR, Silver SM, Mulvaney FD. Rapid eye movement sleep disturbance in posttraumatic stress disorder. Biol Psychiatry. 1994 Feb 1;35(3):195-202. doi: 10.1016/0006-3223(94)91152-5.
PubMed 8173020Ryff, C. D. (1989). Happiness is everything, or is it? Explorations on the meaning of psychological well-being. Journal of Personality and Social Psychology, 57(6), 1069.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Stellate Ganglion Block and Superior Cervical Ganglion Block on Sleep and Recovery Using Biometric Capture Devices
- ClinicalTrials.gov ID
- NCT05470361
- Acronym / sponsor ID
- UQueenslandSGB
- Conditions
- PTSD
- Keywords
- PTSD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Whoop Inc., Stella MSO, LLC
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People who suffer from PTSD | – | Procedure: stellate ganglion block (SGB)The sample will be composed of 30 patients from Stella's Chicago practice: 712 N Dearborn St, Chicago, Illinois 60654 |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- PTSD Symptoms
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | People who suffer from PTSD |
Primary outcome
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.
2 secondary outcomes
Self-reported Post-Traumatic Stress Disorder symptoms
Time frame: 8 weeks
Self-reported depression symptoms
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- BackgroundAlkire, M. T., Hollifield, M., Khoshsar, R., Nguyen, L., Alley, S. R., & Reist, C. (2015, October). Neuroimaging suggests that stellate ganglion block improves post-traumatic stress disorder (PTSD) through an amygdala mediated mechanism. In The Anesthesiology Annual Meeting.
- Background: PubMed 23814343Alvaro PK, Roberts RM, Harris JK. A Systematic Review Assessing Bidirectionality between Sleep Disturbances, Anxiety, and Depression. Sleep. 2013 Jul 1;36(7):1059-1068. doi: 10.5665/sleep.2810.
- Background: PubMed 25749751Bernardy NC, Friedman MJ. Psychopharmacological strategies in the management of posttraumatic stress disorder (PTSD): what have we learned? Curr Psychiatry Rep. 2015 Apr;17(4):564. doi: 10.1007/s11920-015-0564-2.
- Background: PubMed 10948488Feeny NC, Zoellner LA, Fitzgibbons LA, Foa EB. Exploring the roles of emotional numbing, depression, and dissociation in PTSD. J Trauma Stress. 2000 Jul;13(3):489-98. doi: 10.1023/A:1007789409330.
- Background: PubMed 16574638Filipas HH, Ullman SE. Child sexual abuse, coping responses, self-blame, posttraumatic stress disorder, and adult sexual revictimization. J Interpers Violence. 2006 May;21(5):652-72. doi: 10.1177/0886260506286879.
- Background: PubMed 29486547Kim HG, Cheon EJ, Bai DS, Lee YH, Koo BH. Stress and Heart Rate Variability: A Meta-Analysis and Review of the Literature. Psychiatry Investig. 2018 Mar;15(3):235-245. doi: 10.30773/pi.2017.08.17. Epub 2018 Feb 28.
- Background: PubMed 19034755Lipov EG, Joshi JR, Lipov S, Sanders SE, Siroko MK. Cervical sympathetic blockade in a patient with post-traumatic stress disorder: a case report. Ann Clin Psychiatry. 2008 Oct-Dec;20(4):227-8. doi: 10.1080/10401230802435518. No abstract available.
- Background: PubMed 27612365Lynch JH, Mulvaney SW, Kim EH, de Leeuw JB, Schroeder MJ, Kane SF. Effect of Stellate Ganglion Block on Specific Symptom Clusters for Treatment of Post-Traumatic Stress Disorder. Mil Med. 2016 Sep;181(9):1135-41. doi: 10.7205/MILMED-D-15-00518.
- Background: PubMed 33812302Miller JV, Andre Q, Timmers I, Simons L, Rasic N, Lebel C, Noel M. Subclinical post-traumatic stress symptomology and brain structure in youth with chronic headaches. Neuroimage Clin. 2021;30:102627. doi: 10.1016/j.nicl.2021.102627. Epub 2021 Mar 13.
- Background: PubMed 34219849Muldoon OT, Lowe RD, Jetten J, Cruwys T, Haslam SA. Personal and Political: Post-Traumatic Stress Through the Lens of Social Identity, Power, and Politics. Polit Psychol. 2021 Jun;42(3):501-533. doi: 10.1111/pops.12709. Epub 2020 Dec 13.
- Background: PubMed 25269132Mulvaney SW, Lynch JH, Hickey MJ, Rahman-Rawlins T, Schroeder M, Kane S, Lipov E. Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. Mil Med. 2014 Oct;179(10):1133-40. doi: 10.7205/MILMED-D-14-00151.
- Background: PubMed 31693083Rae Olmsted KL, Bartoszek M, Mulvaney S, McLean B, Turabi A, Young R, Kim E, Vandermaas-Peeler R, Morgan JK, Constantinescu O, Kane S, Nguyen C, Hirsch S, Munoz B, Wallace D, Croxford J, Lynch JH, White R, Walters BB. Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):130-138. doi: 10.1001/jamapsychiatry.2019.3474.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD, run by The University of Queensland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William von Hippel, PhD (+614 2293 1198, billvh@psy.uq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05470361, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.