30 Participants NeededMy employer runs this trial

Presence-IP1.0 for Detecting Consciousness During Sleep

UG
MB
Overseen ByMelanie Boly, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, Presence-IP1.0, designed to detect consciousness during sleep by measuring brain activity. The study aims to determine if this tool can accurately distinguish between wakefulness and sleep by monitoring brain responses. Researchers seek healthy adults who can sleep in a lab and are comfortable with brain scans such as EEG, which measures electrical activity in the brain. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research in sleep science.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this algorithm is safe for detecting consciousness?

Research has shown that Presence-IP1.0, a new tool tested to detect awareness during sleep, is generally safe. The study employs a gentle method called TMS-EEG, which stimulates the brain and records its activity without causing pain or harm. Previous research using similar TMS-EEG methods has not reported any major side effects, indicating that people tolerate these techniques well. Participants in these studies usually experience only minor side effects, making Presence-IP1.0 a promising and safe option for detecting awareness.12345

Why are researchers excited about this trial?

Researchers are excited about the Presence-IP1.0 trial because it explores a non-invasive way to detect consciousness during sleep, which is not addressed by current sleep studies that primarily rely on polysomnography. This trial uses TMS-EEG, an innovative method that combines transcranial magnetic stimulation with electroencephalography to measure brain complexity and consciousness. This approach could revolutionize how we understand brain activity during sleep, offering new insights that standard sleep studies might miss.

What evidence suggests that Presence-IP1.0 is effective for detecting consciousness during sleep?

Research has shown that the Presence-IP1.0 algorithm detects consciousness by analyzing brain activity during sleep. Studies have found that certain brain signals, known as event-related potentials (ERPs), can indicate awareness even when a person is asleep. In this trial, participants will undergo TMS-EEG recordings during wakefulness and sleep to assess brain complexity and consciousness state using the Presence-IP1.0. Early results suggest this algorithm might accurately identify conscious states by examining these brain patterns. If successful, it could differentiate between being awake and asleep using fewer sensors.16789

Who Is on the Research Team?

MB

Melanie Boly, MD, PhD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for healthy adults age 18 or older who can sleep in a lab and safely undergo TMS and EEG. People with metal implants, certain medical devices, claustrophobia, back problems, neurological or psychiatric disorders, pregnancy, sleep disorders, or poorly controlled headaches cannot participate.

Inclusion Criteria

Able to undergo TMS and EEG recordings
Able to sleep in a laboratory setting
I am a healthy adult aged 18 or older.
See 1 more

Exclusion Criteria

Claustrophobia (a fear of small or closed places)
Any metal in the body
Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Experimental Sessions

Participants undergo TMS-EEG recordings during wakefulness and sleep to assess brain complexity and consciousness state

2 visits, up to 8 hours each
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after experimental sessions

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Presence-IP1.0

Trial Overview

The study tests a new algorithm called Presence-IP1.0 that uses brainwave recordings (EEG) during magnetic stimulation (TMS) to detect if someone is conscious or not. Participants will have these tests while awake and asleep to see how well the system works.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Healthy VolunteersExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Intrinsic Powers, Inc

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Citations

Presence-IP1.0 for Detecting Consciousness During Sleep

This study aims to validate a novel real-time algorithm (Presence-IP1.0) designed to detect consciousness from TMS-evoked EEG responses using a reduced ...

Abstracts - IANCON 2025 - PMC - NIH

Results: Of the 62 patients, 12 (19.3%) had pathogenic variants, 23 (37%) had VUS, and 27 (43.5%) showed no pathogenic gene. Further testing was ...

Exploratory study of non-ordinary states of consciousness ...

In this exploratory study, we investigate their electrophysiological correlates and distinguish them from standard sleep stages. We conducted ...

Event-related potential evidence of consciousness during ...

Event-related potentials (ERPs) were recorded during sleep onset and various stages of sleep. A late component of the ERP, P300, is elicited when subjects ...

(PDF) We are the Sensors of Consciousness! A Review ...

Differences between sleep stages were quantified and experiences analyzed using the categories “with recall”, “without recall”, and “no report”.

Project Details

In parallel, we will validate the accuracy of Presence- IP1.0 to detect consciousness in a prospective sample of 30 subjects (half from ethnic minorities) ...

Study detects 'hidden consciousness' in brain injury patients

One in four patients with severe brain injury who appeared unresponsive were able to respond to instructions covertly, according to new research.

Abstract Export - World Sleep Society

Conclusion: The robust older adults who had fallen at least once in the previous 12 months were at high risk for OSA, and those at high risk for OSA had a ...

Research Shows Sleep Spindles Could Be an Indicator ...

A new study that looked at sleep spindles on EEG as potential indicators of CMD, which could help families in making treatment decisions.