Induction of Dreaming With EEG and Anesthesia in Healthy Adults

NCT07198711 | Enrolling By Invitation Phase 1 FDA Drug

• 1 other identifier: 55215
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This open-label, randomized crossover study in healthy adults tests two propofol protocols to produce distinct experiential states. One induces brief loss of responsiveness with spontaneous emergence, intended to elicit dream reports; the other maintains light sedation without loss of responsiveness, intended to elicit non-dream experiences while participants remain responsive. The main goals are to (a) measure the protocol-concordant experiential report rate (how often each method produces its intended experience), (b) explore EEG correlates of these experiences in the two states, and (c) describe their phenomenology (what they are like). We will also examine short-term changes in well-being and sleep related to these experiences. Participants complete four sessions (two of each method) with EEG and routine monitoring, immediate post-session interviews, and brief questionnaires and daily sleep/dream logs before and after anesthesia sessions.

Conditions

Healthy Volunteers

Keywords

anesthesia; propofol; dreaming; consciousness

Outcome Measures

Primary Outcomes (1)

• Protocol-concordant experiential report

  Presence vs absence of an experiential report elicited via a structured interview (modified Brice). "Protocol-concordant" is defined as: LOR protocol-success = any dream report upon emergence; Light-sedation (no-LOR) protocol-success = any experiential report that is not a dream (e.g., imagery, sounds, thoughts, bodily sensations, hypnagogic-like experiences) while the participant remained behaviorally responsive.

  Assessed within 5 minutes of return of responsiveness (LOR protocol) or within 5 minutes of session end (light-sedation protocol).

Secondary Outcomes (18)

• EEG correlates of protocol-concordant experiential outcome

  Matched-duration EEG windows during the 30-minute maintenance period: pre-emergence window prior to return of responsiveness in the LOR protocol, and a time-matched window during maintenance in the no-LOR protocol.

• Phenomenology of anesthesia experiences (analysis of narrative reports)

  Interview immediately post-session

• Phenomenology of anesthesia experiences (self-ratings)

  Interview immediately post-session

• Dream vs dream-like experiences (within-anesthesia) - phenomenological differences

  Interview immediately post-session

• Home dreams vs anesthesia dreams - phenomenological differences

  Home dream logs (2 weeks pre-session and 2 weeks post-session) vs anesthesia interview (immediate post-session).

Study Arms (2)

Emergence-from-LOR Protocol

EXPERIMENTAL

Participants receive propofol titrated to loss of responsiveness (LOR) followed by maintenance and spontaneous emergence. This protocol is designed to elicit dream reports upon emergence (i.e., reports of subjective experiences occurring during the unresponsiveness period)

Drug: Propofol - Emergence-from-LOR Protocol

No-LOR Light Sedation Protocol

EXPERIMENTAL

Participants receive propofol titrated stepwise to light sedation without LOR, maintaining responsiveness. This protocol is designed to elicit non-dream experiential reports while responsive (e.g., simple imagery, sounds, thoughts, bodily sensations, hypnagogic-like experiences).

Drug: Propofol - Light Sedation Protocol

Interventions

Propofol - Emergence-from-LOR Protocol DRUG

Intravenous propofol infusion that meets the criteria: (1) maintenance of spontaneous ventilation, (2) sedation level corresponding to a Patient State Index (PSI) no lower than 25; and (3) loss of responsiveness (LOR) defined by the Richmond Agitation Sedation Scale (RASS) = -5 \[unarousable\]. Anesthesia is then maintained at that level for 30 minutes, followed by spontaneous emergence.

Emergence-from-LOR Protocol

Propofol - Light Sedation Protocol DRUG

Intravenous propofol infusion titrated stepwise to reach a state where participants are sedated but have behavioral responsiveness. Sedation is maintained at this level for 30 minutes.

No-LOR Light Sedation Protocol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 to 70 years of age, inclusive, at screen.
• Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
• 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 1 or 2.
• If female, a status of non-childbearing potential or use of an acceptable form of birth control
• Body mass index between 17-35 kg/m2.

You may not qualify if:

• Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
• Female that is pregnant or breastfeeding.
• Female with a positive pregnancy test at screening or baseline.
• Current diagnosis of a Substance Use Disorder (SUD; Abuse or Dependence, as defined by DSM-V) rated "moderate" or "severe", or Alcohol Use Disorder rated "moderate" or "severe". 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.
• 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
• History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms
• History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within five years of screening.
• 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.
• A neurological disorder including:
• Has dementia, delirium, amnestic, or any other cognitive disorder.
• Lifetime history of surgical procedures involving the brain or meninges,
• encephalitis, meningitis, degenerative central nervous system disorder (e.g., Alzheimer's or Parkinson's Disease), epilepsy, mental retardation
• any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system (CNS),
• history of significant head trauma within the past two years.
• A cardiovascular disorder including:

Sponsors & Collaborators

• Stanford University: lead
• Tiny Blue Dot Foundation: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

• Chow HS, Hack LM, Kawai M, Heifets BD. Anesthetic-Induced Intraoperative Dream Associated With Remission of a Psychiatric Disorder: A Case Report. A A Pract. 2022 Aug 10;16(8):e01613. doi: 10.1213/XAA.0000000000001613. eCollection 2022 Aug 1.

  PMID: 35952341 BACKGROUND

• Hack LM, Sikka P, Zhou K, Kawai M, Chow HS, Heifets B. Reduction in Trauma-Related Symptoms After Anesthetic-Induced Intra-Operative Dreaming. Am J Psychiatry. 2024 Jun 1;181(6):563-564. doi: 10.1176/appi.ajp.20230698. Epub 2024 Mar 13. No abstract available.

  PMID: 38476046 BACKGROUND

Study Officials

• Dr. Boris D Heifets, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology, Perioperative and Pain Medicine

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 30, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the completion of the study and upon publishing the results

Locations

US (1)