RECRUITING

Induction of Dreaming With EEG and Anesthesia for Post-traumatic Stress Disorder

Conditions

PTSD Post-traumatic Stress Disorder anesthesia propofol dreaming dreams

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to test whether anesthesia-induced dreaming can help alleviate symptoms of PTSD in an (1) open-label trial (Phase I) and (2) double-blind, randomized controlled trial (Phase II) in a non-surgical setting. The investigators predict that inducing and sustaining a dream state prior to emergence from anesthesia will result in reduced symptoms of PTSD. Participants will undergo EEG-guided propofol anesthesia during which they will be either (1) receiving deep sedation leading to loss of responsiveness, designed to elicit dream reports upon emergence (Dream Protocol), and/or (2) light sedation without loss of responsiveness, designed to elicit non-dream experiential reports while responsive (e.g., simple imagery, sounds, thoughts, bodily sensations, hypnagogic-like experiences) (Non-Dream Protocol). The investigators will then investigate whether the deep-sedation Dream Condition is associated with a larger reduction in PTSD symptoms than the light-sedation Non-Dream Condition.

Official Title

Efficacy of Anesthesia-induced Dreaming for Post-traumatic Stress Disorder: a Randomized Controlled Trial

Quick Facts

Study Start:2025-07-21

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06577636

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.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female, 18 to 70 years of age 2. Able to read, understand, and provide written, dated informed consent prior to screening. 3. Diagnosed with PTSD prior to screening, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition. The diagnosis of PTSD will be made by a trained study staff member and supported by the Structured Clinical Interview for DSM Disorders (SCID). 4. Meet the threshold of CAPS-5 score of \>20 during screening. 5. In sufficiently good health to proceed with a low-risk elective procedure, characterized using the American Society of Anesthesiologists (ASA) physical status classification system as Class I or II. 6. If female, a status of non-childbearing potential or use of an acceptable form of birth control 7. Body mass index between 17-35 kg/m2.	1. Female who is pregnant or breastfeeding. 2. Total CAPS-5 score ≤20 at either the screening. 3. Current diagnosis of a Substance Use Disorder (SUD; Abuse or Dependence, as defined by DSM-V) rated "moderate" or "severe" per criteria of the SCID, or Alcohol Use Disorder rated "moderate" or "severe" per SCID criteria. The following categories of SUD will NOT be excluded: nicotine dependence; alcohol or substance use disorder rated "mild"; alcohol or substance use disorder of any severity in remission, either early (3-12 months) or sustained (\>12 months) time frames. 4. Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Specific Phobia, or Bipolar II Disorder (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more) 5. History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes. 6. History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within five years of screening. 7. Any Axis I or Axis II Disorder, which at screening is clinically predominant to their PTSD or has been predominant to their PTSD at any time within six months prior to screening. 8. In the judgment of the investigator, the subject is at significant risk for suicidal behavior during the course of his/her participation in the study. 9. A neurological disorder 10. A cardiovascular disorder 11. A pulmonary/respiratory disorder 12. Clinically significant liver disease 13. Clinically significant kidney disease 14. Symptomatic gastroesophageal reflux disease, hiatal hernia, or other gastrointestinal disorder placing patient at risk for aspiration or that would merit categorization of patient as ASA Class III or higher 15. An endocrine disorder 16. Any other abnormal laboratory result at the time of the screening exam that in the view of the investigator poses a risk for participation in the study. 17. If, in the view of the participant's current primary mental health care provider this study poses a risk for participation (if a participant has a current mental health care provider). 18. Participation in any clinical trial with an investigational drug or device that conflicts with this trial, within the past month or concurrent to study participation.

Inclusion Criteria

Exclusion Criteria

1. Male or female, 18 to 70 years of age
2. Able to read, understand, and provide written, dated informed consent prior to screening.
3. Diagnosed with PTSD prior to screening, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition. The diagnosis of PTSD will be made by a trained study staff member and supported by the Structured Clinical Interview for DSM Disorders (SCID).
4. Meet the threshold of CAPS-5 score of \>20 during screening.
5. In sufficiently good health to proceed with a low-risk elective procedure, characterized using the American Society of Anesthesiologists (ASA) physical status classification system as Class I or II.
6. If female, a status of non-childbearing potential or use of an acceptable form of birth control
7. Body mass index between 17-35 kg/m2.

1. Female who is pregnant or breastfeeding.
2. Total CAPS-5 score ≤20 at either the screening.
3. Current diagnosis of a Substance Use Disorder (SUD; Abuse or Dependence, as defined by DSM-V) rated "moderate" or "severe" per criteria of the SCID, or Alcohol Use Disorder rated "moderate" or "severe" per SCID criteria. The following categories of SUD will NOT be excluded: nicotine dependence; alcohol or substance use disorder rated "mild"; alcohol or substance use disorder of any severity in remission, either early (3-12 months) or sustained (\>12 months) time frames.
4. Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Specific Phobia, or Bipolar II Disorder (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more)
5. History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
6. History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within five years of screening.
7. Any Axis I or Axis II Disorder, which at screening is clinically predominant to their PTSD or has been predominant to their PTSD at any time within six months prior to screening.
8. In the judgment of the investigator, the subject is at significant risk for suicidal behavior during the course of his/her participation in the study.
9. A neurological disorder
10. A cardiovascular disorder
11. A pulmonary/respiratory disorder
12. Clinically significant liver disease
13. Clinically significant kidney disease
14. Symptomatic gastroesophageal reflux disease, hiatal hernia, or other gastrointestinal disorder placing patient at risk for aspiration or that would merit categorization of patient as ASA Class III or higher
15. An endocrine disorder
16. Any other abnormal laboratory result at the time of the screening exam that in the view of the investigator poses a risk for participation in the study.
17. If, in the view of the participant's current primary mental health care provider this study poses a risk for participation (if a participant has a current mental health care provider).
18. Participation in any clinical trial with an investigational drug or device that conflicts with this trial, within the past month or concurrent to study participation.

Contacts and Locations

Study Contact

Boris D Heifets, MD, PhD

CONTACT

(669) 241 6118

bheifets@stanford.edu

Pilleriin Sikka, PhD

CONTACT

6506808801

sikka@stanford.edu

Principal Investigator

Boris D Heifets, MD, PhD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Stanford University

Stanford, California, 94305

United States

Collaborators and Investigators

Sponsor: Stanford University

Boris D Heifets, MD, PhD, PRINCIPAL_INVESTIGATOR, Stanford University

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 Registration Dates

Study Start Date2025-07-21

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-07-21

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

anesthesia
propofol
PTSD
post-traumatic stress disorder
dreaming
dreams

Additional Relevant MeSH Terms

PTSD
Post-traumatic Stress Disorder