Recruiting

Observational Study

Sponsor:

Sensorum Health Inc.

Code:

NCT05865197

Conditions

CHF

Congestive Heart Failure

Eligibility Criteria

Sex: All

Age: 55+

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

CHF

Congestive Heart Failure

Study ID

NCT05865197

Start date

Nov 28, 2022

Status verified date

Jan, 2024

Completion date

Sep 1, 2024

Anticipated

Primary completion date

Aug 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Current Patient at Weill Cornell Medicine
  • Aged 55 years or older
  • Able to consent
  • Documented diagnosis of congestive heart failure (CHF)
  • At least 1 of the following prior hospital utilization events in the past 12 months
  • Inpatient admission for any reason
  • Facility observation stay for any reason
  • Emergency Department visit for any reason

Exclusion Criteria:

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

Study Design

Enrollment

20 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: 6 months ]
  • Precision of AI in passive sensor system [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Christine Fernandez

(973) 786-3573christine@sensorum.ai

Andrew Hotchkiss

(973) 946-8382andrew@sensorum.ai

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Kate Zarzuela

646-962-5909kaz4004@med.cornell.edu

More Information

Sponsor

Sensorum Health Inc.

Last update posted

Jan 16, 2024

Last verified

Jan, 2024

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 2024-01-16.