NCT06135285

Brief Summary

The goal of this feasibility study is to test the Korus smart mattress in healthy volunteers. The main questions it aims to answer are:

  • Can Korus accurately detect body position in bed (left, right, supine, prone)
  • Can Korus reposition the subject from a prone to recovery (sideways) position? Participants will be asked to lie down on Korus and turn into various positions; when the prone position is detected, they will be repositioned.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Jun 2027

First Submitted

Initial submission to the registry

November 6, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2.5 years until next milestone

Study Start

First participant enrolled

May 15, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

November 6, 2023

Last Update Submit

March 25, 2026

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

  • Body position detection

    Correct detection of one of 4 cardinal body positions: prone, supine, left, right

    5 seconds

  • Number of subjects correctly repositioned from the prone to recovery position

    We will measure the performance of Korus to successfully reposition the subject from the prone to recovery position

    30 seconds

Study Arms (1)

Control subjects

EXPERIMENTAL

The subject will lie down on the Korus smart mattress. Korus will detect when the subject is in a prone (face-down) position and reposition the subject into a recovery (sideways) position.

Device: Control subjects

Interventions

Control subjectsDEVICE

The subject will be repositioned from the prone to recovery position

Control subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults age 18-65; at least 30% of subjects will be self-identified as prone sleepers

You may not qualify if:

  • History of neurological dysfunction, including spinal cord abnormalities
  • History of psychiatric disorder, including anxiety
  • History of cardiac dysfunction
  • History of osteoporosis or osteopenia
  • History of significant orthopedic dysfunction
  • History of falls
  • History of sleep disorder
  • Taking neuroactive medications
  • Taking anticoagulants
  • Current recreational drug use
  • BMI under 18 or over 30
  • Systolic BP \>180 or \<90
  • Open wounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • Ryvlin P, Nashef L, Lhatoo SD, Bateman LM, Bird J, Bleasel A, Boon P, Crespel A, Dworetzky BA, Hogenhaven H, Lerche H, Maillard L, Malter MP, Marchal C, Murthy JM, Nitsche M, Pataraia E, Rabben T, Rheims S, Sadzot B, Schulze-Bonhage A, Seyal M, So EL, Spitz M, Szucs A, Tan M, Tao JX, Tomson T. Incidence and mechanisms of cardiorespiratory arrests in epilepsy monitoring units (MORTEMUS): a retrospective study. Lancet Neurol. 2013 Oct;12(10):966-77. doi: 10.1016/S1474-4422(13)70214-X. Epub 2013 Sep 4.

    PMID: 24012372BACKGROUND

  • Tao JX, Sandra R, Wu S, Ebersole JS. Should the "Back to Sleep" campaign be advocated for SUDEP prevention? Epilepsy Behav. 2015 Apr;45:79-80. doi: 10.1016/j.yebeh.2015.02.020. Epub 2015 Apr 11. No abstract available.

    PMID: 25875185BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jong Woo Lee, MD, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong Woo Lee, MD, PhD

CONTACT

617-732-7547jlee38@bwh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 18, 2023

Study Start

May 15, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

We will collect and generate the following data from 50 normative control subjects: a) spontaneous body position as recorded by the KORUS sensor; b) subject demographics: age, sex, height, weight

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
All data will be deposited starting 12 months after the study completion
Access Criteria
To request access of the data, researchers will use the standard processes at PhysioNet, where the data will be stored, which will decide which requests to grant.

Locations

US(1)