Recruiting

Observational Study

Sponsor:

Sensorum Health Inc.

Code:

NCT05865184

Conditions

COPD

Chronic Obstructive Pulmonary Disease

COPD Exacerbation

CHF

Congestive Heart Failure

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Data collection

Study Details

Brief summary:

Sensorum Health (Sensorum) is conducting a pilot study to determine if Sensorum's proprietary passive sensor network can be used to identify signals of early health decompensation in subjects prior to a hospitalization for chronic disease exacerbation or other ambulatory care sensitive conditions. Successful early detection would provide a window of opportunity to intervene outside of the acute setting in future interventional studies.

Conditions

COPD

Chronic Obstructive Pulmonary Disease

COPD Exacerbation

CHF

Congestive Heart Failure

Study ID

NCT05865184

Start date

Sep 28, 2022

Status verified date

May, 2023

Completion date

Jun 6, 2024

Anticipated

Primary completion date

Jun 6, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged 65 years or older
  • Able to consent
  • Documented history of diagnosis of chronic obstructive pulmonary disease (COPD) and/or congestive heart failure (CHF)
  • Currently admitted to JSUMC for observation or as an inpatient with any diagnosis ≥1 prior hospital utilization events with any diagnosis (inpatient admissions, facility observation stays, or ED visits) in the past 12 months

Exclusion Criteria:

  • Significant cardiac valvular disease
  • End-Stage Renal Disease (ESRD)
  • End-Stage CHF
  • End-Stage COPD

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Passive monitoring

No intervention

Interventions

Data collection

Data collection of clinically relevant signals using home-based sensor system

Primary outcome measure

  • Recall of AI in passive sensor system [ Time Frame: 90 days ]
  • Precision of AI in passive sensor system [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Christine Fernandez

(973) 786-3573christine@sensorum.ai

Andrew Hotchkiss

(973) 946-8382andrew@sensorum.ai

Locations

Jersey Shore University Medical Center, Hackensack Meridian Health

Recruiting

Neptune, New Jersey, United States, 07753

Contacts

Tracy Micalizzi

551-238-3488tracy.micalizzi@hmhn.org

Principal Investigator:

Swapnel Patel, MD

More Information

Sponsor

Sensorum Health Inc.

Last update posted

May 18, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sensorum Health Inc. on 2023-05-18.