Hypnosis-Based Machine Learning Biomarker Study

Not Applicable

Recruiting

• Conditions: Disorder; Trance; Anxiety

• Registration Number: NCT07102810
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

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 Timeline

• Study First Submitted: 2025-07-30
• Study First Submitted QC: 2025-07-30
• Status Verified: 2025-08
• Study Start: 2025-08-04
• Study First Posted: 2025-08-05
• Last Update Submitted: 2025-08-05
• Last Update Posted: 2025-08-08
• Primary Completion: 2025-09-05
• Study Completion: 2025-09-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory (STAI) Subscale Scores	Immediately Pre- and immediately post-hypnosis session (single study visit)	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.
Respiratory Rate (RR)	Immediately Pre-, During, and immediately post-hypnosis session (single study visit)	Mean respiratory rate (breaths per minute) obtained from a respiration belt and ECG-derived signals.
Electrodermal Activity (EDA)	Immediately Pre-, During, and immediately post-hypnosis session (single study visit)	Skin conductance level and phasic response rate measured using BIOPAC sensors.
EEG Spectral Power	Immediately Pre-, During, and immediately post-hypnosis session (single study visit)	Power values in EEG frequency bands collected across 21 electrodes during baseline, hypnotic induction, and post-session phases.
Heart Rate (HR)	Immediately Pre-, During, and immediately post-hypnosis session (single study visit)	Mean heart rate (beats per minute) captured continuously using a wearable chest patch before, during, and after hypnosis session.
Heart Rate Variability (HRV)	Immediately Pre-, During, and immediately post-hypnosis session (single study visit)	Time and frequency domain HRV metrics derived from wearable ECG data.
Pre-Ejection Period (PEP)	Immediately Pre-, During, and immediately post-hypnosis session (single study visit)	Pre-ejection period (ms), a marker of sympathetic nervous system activity, measured via seismocardiogram from chest patch.
Respiratory Sinus Arrhythmia (RSA)	Immediately Pre-, During, and immediately post-hypnosis session (single study visit)	RSA index (ms²), derived from heart rate and respiration synchrony during hypnotic protocol.

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States