Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Boris D Heifets, MD, PhD
CONTACT
Pilleriin Sikka, PhD
CONTACT
Lead
Stanford University
With
GENERAL BACKGROUND Post-traumatic stress disorder (PTSD) affects millions of Americans, and it can make everyday life very challenging. PTSD is characterized by recurrent distressing memories and nightmares, flashbacks, hyperarousal, and avoidance of things that remind individuals of their traumatic event. Nightmares reflect impaired emotion regulation occurring during sleep. There is evidence that therapeutic applications of dreaming may help target nightmares and other PTSD symptoms because dreaming is involved in memory (re)processing and emotion regulation. There is preliminary evidence that dreaming during anesthesia may reduce symptoms of PTSD. However, larger studies are needed to systematically test this. AIM AND HYPOTHESES The aim of this study is to test the efficacy of anesthesia-induced dreaming for PTSD in a (1) open-label trial (Phase I) and (2) a single-center double-blind, randomized, active-comparator (dose-controlled) participant-and assessor-blinded clinical 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. STUDY DESIGN Design: Phase I : Open-label study Phase II: Double-blind, randomized, active-comparator (dose-controlled) participant-and assessor-blinded Phase 2 clinical trial (RCT) Sample Size: Phase I: N = 15 Phase II: N = 42 (21 in Dream Condition, 21 in Non-Dream Condition) Variables: Phase I and II: Outcome variables include: (1) Clinician-Administered PTSD Scale for DSM-5 (CAPS-5); (2) PTSD Checklist for DSM-5 (PCL-5) STUDY PROCEDURES AND MEASURES This research study is expected to take approximately four months to complete (per participant). During this time, participants will make two pre-screening visits via Zoom as well as one screening visit via Zoom and one in-person screening visit at Stanford Hospital. Participants will also complete daily assessments of sleep quality and dream experiences 2 weeks before and 2-4 weeks after the anesthesia session. In Phase I, participants will also wear the Muse headband to measure sleep quantity and quality daily for 2 weeks before and 2 weeks after the intervention session. In Phase II, participants will wear a GGX EEG Patch to measure sleep quantity and quality for 2 weeks before and 4 weeks after the intervention session. Participants will fill in pre-anesthesia and post-anesthesia questionnaires measuring mental health and well-being and, complete follow-up measures 1 day, 1 week, 2 weeks, 1 month, and 3 months after the anesthesia session. During the anesthesia session, participants will undergo EEG-guided infusion of propofol. In Phase I, all participants will undergo at least two sessions: (1) a sedation protocol intended to elicit dream reports (Dream Condition); and (ii) a sedation protocol designed to elicit non-dream experiential reports (Non-Dream Condition). In Phase II, participants will be randomized into either the Dream or Non-Dream Group, undergoing either the protocol designed to elicit dream experiences or non-dream experiences, respectively. Immediately upon emerging from anesthesia, participants will be interviewed using the modified Brice questionnaire and their responses audio- and video-recorded.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
