Sleep/Wake State Assessment with Non-invasive Earbuds

NCT ID: NCT05066009

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-13
• Study Completion Date: 2023-10-27

Brief Summary

This study is a within subject's assessment of whether a novel wearable technology, NextSense electroencephalography earbuds (EEGBuds), is able to detect differences in onset to sleep from wake versus in-laboratory, gold-standard electroencephalography (EEG) utilized as part of a standard four trial Maintenance of Wakefulness Test (MWT) at medicated baseline versus free of prescribed medications for promoting wake (random order).

Detailed Description

Detection of "sleepiness" has for more than four decades relied upon methods that acquire the electroencephalogram (EEG) from multiple surface electrodes applied to the scalp and hardware that amplifies and stores information on a central processing unit (CPU). There are substantial limitations to this methodology beyond the fact that it is time, labor, and cost intensive. Such procedures restrict a subject's freedom of movement and necessitate that patients are monitored by trained staff in an accredited laboratory which levies substantial time and financial burdens upon patients and families. Finally, the test-re-test reliability and utility of testing paradigms reliant solely on an EEG 'signature' to detect statistically meaningful - let alone clinically meaningful - changes is dubious, and has come under increased scrutiny.

This study will assess whether novel wearable technology (NextSense EEGBuds and/or Ellcie Healthy Glasses) are able to detect differences in onset to sleep in patients diagnosed as having one of the central disorders of hypersomnolence (e.g., narcolepsy type 1 or type 2, or idiopathic hypersomnia) while using their prescribed wake promoting medication(s) versus while they are not medicated, and how it's sensitivity compares to differences as detected by the standard MWT. The two study visits will occur within 16 days of one another.

Conditions

Hypersomnolence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

Prescribed medication followed by drug holiday

Participants will complete the study assessments on a day when they take their prescribed medication(s) to promote wakefulness and then will repeat the study assessments on a day when they do not take the medication.

Group Type: EXPERIMENTAL

NextSense EEG-enabled earbuds

Intervention Type: DEVICE

Each NextSense EEGBud device comes with a universal-fit and/or custom-fit earmold with biometric sensors to detect the EEG, motion (via tri-axial accelerometers), and heart rate. A unique custom mold is created employing a 3D printer to capture the geometry of a patients' ear and external auditory canal with a ring laser scanner to an accuracy of within 0.1 mm. This design process allows for a custom fit, and therefore both comfort and complete, consistent contact with the inner surface of the ear canal, providing high quality signal capture of brain activity, and head and eye movements. In addition to the custom fit earmold, universal fit earmolds are available as well. The universal fit earmolds were designed also to allow for comfort and consistent contact with the inner surface of the ear canal to provide high quality signal capture of brain activity, and head and eye movements.

Ellcie Healthy eyeglasses

Intervention Type: DEVICE

Ellcie Healthy glasses frames are embedded with multi-modal sensors for measuring eye movements, head movement, and ECG.

Drug Holiday

Intervention Type: OTHER

Participants will not take their prescribed wakefulness promoting medication(s) for one day to complete the study assessments. Medications typically used to promote wakefulness include amphetamine salts (Adderall), armodafinil (Nuvigil), clarithromycin (Biaxin), flumazenil, methylphenidate (Ritalin), and modafinil (Provigil).

Drug holiday followed by prescribed medication

Participants will complete the study assessments on a day when they do not take their prescribed medication(s) to promote wakefulness and then will repeat the study assessments on a day when they take their medication as prescribed.

Group Type: EXPERIMENTAL

NextSense EEG-enabled earbuds

Intervention Type: DEVICE

Each NextSense EEGBud device comes with a universal-fit and/or custom-fit earmold with biometric sensors to detect the EEG, motion (via tri-axial accelerometers), and heart rate. A unique custom mold is created employing a 3D printer to capture the geometry of a patients' ear and external auditory canal with a ring laser scanner to an accuracy of within 0.1 mm. This design process allows for a custom fit, and therefore both comfort and complete, consistent contact with the inner surface of the ear canal, providing high quality signal capture of brain activity, and head and eye movements. In addition to the custom fit earmold, universal fit earmolds are available as well. The universal fit earmolds were designed also to allow for comfort and consistent contact with the inner surface of the ear canal to provide high quality signal capture of brain activity, and head and eye movements.

Ellcie Healthy eyeglasses

Intervention Type: DEVICE

Ellcie Healthy glasses frames are embedded with multi-modal sensors for measuring eye movements, head movement, and ECG.

Drug Holiday

Intervention Type: OTHER

Participants will not take their prescribed wakefulness promoting medication(s) for one day to complete the study assessments. Medications typically used to promote wakefulness include amphetamine salts (Adderall), armodafinil (Nuvigil), clarithromycin (Biaxin), flumazenil, methylphenidate (Ritalin), and modafinil (Provigil).

Interventions

NextSense EEG-enabled earbuds

Each NextSense EEGBud device comes with a universal-fit and/or custom-fit earmold with biometric sensors to detect the EEG, motion (via tri-axial accelerometers), and heart rate. A unique custom mold is created employing a 3D printer to capture the geometry of a patients' ear and external auditory canal with a ring laser scanner to an accuracy of within 0.1 mm. This design process allows for a custom fit, and therefore both comfort and complete, consistent contact with the inner surface of the ear canal, providing high quality signal capture of brain activity, and head and eye movements. In addition to the custom fit earmold, universal fit earmolds are available as well. The universal fit earmolds were designed also to allow for comfort and consistent contact with the inner surface of the ear canal to provide high quality signal capture of brain activity, and head and eye movements.

Intervention Type: DEVICE

Ellcie Healthy eyeglasses

Ellcie Healthy glasses frames are embedded with multi-modal sensors for measuring eye movements, head movement, and ECG.

Intervention Type: DEVICE

Drug Holiday

Participants will not take their prescribed wakefulness promoting medication(s) for one day to complete the study assessments. Medications typically used to promote wakefulness include amphetamine salts (Adderall), armodafinil (Nuvigil), clarithromycin (Biaxin), flumazenil, methylphenidate (Ritalin), and modafinil (Provigil).

Intervention Type: OTHER

Other Intervention Names

EEGBud

Eligibility Criteria

Inclusion Criteria

• Adults ages 18-60 years of age previously diagnosed with narcolepsy type I (NT1), narcolepsy type 2 (NT2), or idiopathic hypersomnia (IH).
• Requiring daily wake promoting medication(s) continuously for 3 months for diagnosed NT1, NT2 or IH with symptomatic improvement on treatment documented by standard subjective or objective tools.

Exclusion Criteria

• Presence of a diagnosed or suspected co-morbid sleep-related breathing disorder, parasomnia, or other sleep-related movement disorder.
• Unstable psychiatric disorder (e.g., acute psychosis, acute suicidal ideation or major depressive episode, active substance abuse/dependence).
• History of malignancy (active or in remission for < 2 years) or active infectious disease at time of screening.
• Inability to safely tolerate wearing earbuds due to recent injury, skin breakdown, or infection.
• Uncorrected near visual acuity no worse than 20/50.
• Any other condition which may affect the outcome of this study or safety of the participant as determined by the principal investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NextSense, Inc.

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

David Rye

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Rye, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Sleep Center

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

STUDY00002651

Identifier Type: -

Identifier Source: org_study_id