Hypnosis-Based Machine Learning Biomarker Study

Standardized Hypnotic Susceptibility Testing to Facilitate Development of a Machine Learning Tool to Characterize Physiological Biomarkers of Calm and Tranced States

This study seeks to contribute to the growing body of literature on hypnosis by providing robust, data-driven insights into the physiological mechanisms underlying trance states. The integration of electroencephalogram (EEG) and other wearable-derived physiological data will offer a comprehensive assessment of the changes that occur during a standardized hypnosis protocol: the Harvard Group Scale of Hypnotic Susceptibility (HGSHS:A). The results of this study are intended to facilitate derivation and validation of an Artificial Intelligence/Machine Learning (AI/ML)-based monitor that quantifies a patient's instantaneous emotional/arousal state along the spectrum that spans anxiety through states of calmness and trance. Future investigations will explore the ability of using such an interactive virtual system as a component of a closed-loop adaptive device to create optimal states of non-pharmacological sedation using personalized audiovisual content to allay anxiety and discomfort during medical procedures, such as percutaneous biopsies.

Study Overview

• Status: Completed
• Conditions: Anxiety; Disorder; Trance
• Intervention / Treatment: Behavioral: Standardized Hypnotic Susceptibility Testing

Detailed Description

This is an interventional study that will acquire data to characterize the time course of physiological biomarkers and audiovisual observations of depth of trance before, during and upon emergence from a standardized hypnotic susceptibility protocol. The subjects will also complete the State Trait Anxiety Inventory (STAI) immediately before and after the hypnosis protocol. The differences in the biomarker signals among subjects of different degrees of hypnotic susceptibility and different pre-post levels of state anxiety will facilitate between- and within-subjects comparisons that will be supplemented by computer vision analysis of subject responses. The full data set will be used to facilitate derivation and validation of a novel machine-learning monitoring tool to measure instantaneous emotional/arousal levels along a spectrum that spans anxiety through calmness and trance.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Written informed consent obtained from participant and ability and willingness for participant to comply with the requirements of the study.
• Adults of all genders, ages 18-65
• Healthy volunteers
• English-speaking

Exclusion Criteria:

• Participating currently in experimental drug trials.
• Recent (<1 year) or current history of substance use disorder.
• Diabetes T1 or T2, major cardiovascular or respiratory diseases, major neurological diseases, or limited mobility
• Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
• Adults that cannot consent.
• Chronic use of psychoactive medications.
• Chronic use of antiepileptic medications.
• Active substance use disorder.
• Participants reporting significant phobias or anxiety disorders triggered by imagery or situations involving insects (specifically flies), enclosed spaces or elevators (claustrophobia), or heights (acrophobia).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guided Hypnosis; All participants will undergo a single, standardized hypnotic susceptibility protocol using the Harvard Group Scale of Hypnotic Susceptibility: Form A (HGSHS:A).	Behavioral: Standardized Hypnotic Susceptibility Testing; Participants will be guided through the Harvard Group Scale of Hypnotic Susceptibility: Form A (HGSHS:A), a validated group hypnosis protocol that includes standardized hypnotic inductions and suggestibility tasks.; Other Names: HGSHS:A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harvard Group Scale of Hypnotic Susceptibility (HGSHS:A) Total Score	Total score (0-12) reflecting responsiveness to hypnotic suggestion during standardized protocol. Higher scores suggest greater responsiveness to hypnotic suggestion.	During hypnosis session (single study visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety Inventory (STAI) Subscale Scores	The State-Trait Anxiety Inventory is a 40-item instrument divided into two subscales: state and trait anxiety. State Subscale range from 20-80, with higher score suggesting more anxiety at a particular moment in time. Trait Subscale range from 20-80, with higher score suggesting general anxiety feelings overall. These will not be summed therefore there will not be one total scale.	Immediately Pre- and immediately post-hypnosis session (single study visit)
EEG Spectral Power	Power values in EEG frequency bands collected across 21 electrodes during baseline, hypnotic induction, and post-session phases.	Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Heart Rate (HR)	Mean heart rate (beats per minute) captured continuously using a wearable chest patch before, during, and after hypnosis session.	Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Heart Rate Variability (HRV)	Time and frequency domain HRV metrics derived from wearable ECG data.	Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Respiratory Rate (RR)	Mean respiratory rate (breaths per minute) obtained from a respiration belt and ECG-derived signals.	Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Electrodermal Activity (EDA)	Skin conductance level and phasic response rate measured using BIOPAC sensors.	Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Pre-Ejection Period (PEP)	Pre-ejection period (ms), a marker of sympathetic nervous system activity, measured via seismocardiogram from chest patch.	Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Respiratory Sinus Arrhythmia (RSA)	RSA index (ms²), derived from heart rate and respiration synchrony during hypnotic protocol.	Immediately Pre-, During, and immediately post-hypnosis session (single study visit)

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Entrancing Entertainment, Inc.
• Investigators: Principal Investigator: David L Reich, MD, Icahn School of Medicine at Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2025
• Primary Completion (Actual): September 9, 2025
• Study Completion (Actual): September 9, 2025

Study Registration Dates

• First Submitted: July 30, 2025
• First Submitted That Met QC Criteria: July 30, 2025
• First Posted (Actual): August 5, 2025

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Anxiety; Hypnosis; Machine Learning; Trance; Calm
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Osteopetrosis, mild autosomal recessive form; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives
• Other Study ID Numbers: STUDY-25-00767

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregate deidentified data and results will be shared. Individual participant video and EEG data will not be shared due to PHI concerns.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No