Dozee contactless tracking of heart rate, breathing, and movement

Clinical Validation of the Dozee System for Contactless Monitoring of Heart Rate, Respiration Rate, Motion, and Bed-Exits

This study will test whether the Dozee under‑mattress sensor can accurately track heart rate and breathing rate in adults using three different sensor sheets.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Turtle Shell Technologies Pvt. Ltd. (Industry-sponsored)
• Locations: 1 site (Midland, Texas)
• Trial ID: NCT07223931 on ClinicalTrials.gov

What this trial studies

The Dozee VS system uses a thin sensor sheet placed under the mattress to detect tiny body vibrations and applies AI algorithms to produce real‑time heart rate and breathing rate outputs. In this observational validation, consenting adults within the specified weight range will be monitored on beds equipped with one of three sensor sheet types (DS, S1, S1‑I) while simultaneous reference measurements (standard ECG and respiratory reference) are recorded. Hardware upgrades include dual‑sensor sheets and Gen 2 AI/ML heart rate and improved respiratory algorithms designed to be more robust across mattress types and patient movement. Collected data will be compared to clinical reference standards to confirm whether the updated algorithms meet required accuracy thresholds across sheets and patient subgroups.

Who should consider this trial

Good fit: Ideal candidates are consenting adults (18 years or older) weighing 40–120 kg who can lie on the mattress, agree to not eat during testing, and can independently get in and out of bed.

Not a fit: Patients who are connected to devices that interfere with monitoring, require bedside care or procedures during testing, cannot tolerate ECG leads or a nasal cannula, or have significant conditions judged by the investigator are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, Dozee could enable comfortable, continuous contactless vital‑sign monitoring that reduces reliance on straps or nasal tubes and helps spot early deterioration.

How similar studies have performed: Previous validations of under‑mattress and other contactless ballistocardiography systems have shown promising accuracy for heart and respiratory rates, but the specific Gen 2 AI algorithms and dual‑sensor sheet combination are newer and require dedicated validation.

Eligibility criteria

Inclusion Criteria:

Subjects will be included if they meet the following inclusion criteria:

1. Adults Male or female. (Above 18 years of age)
2. Provide written informed consent.
3. Weight between 40kg/88.18lbs and 120kg/264.55lbs
4. Agree to not eat during the testing period
5. Able to move and exit the bed independently and safely.

Exclusion Criteria:

Subjects will be excluded if they have any of the following inclusion criteria:

1. Are connected to a device that may interfere with the device monitoring in this study.
2. Are receiving any bedside care which may be incompatible with the study procedures.
3. A likely need to receive or undergo a procedure during the testing period.
4. Cannot accept a nasal cannula, or have an ECG leads placed on the chest.
5. Have a significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.

Where this trial is running

Midland, Texas

• ERA Health Research — Midland, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Sapna Chilka, MD — ERA Health Research
• Study coordinator: Hinali Zhaveri

Conditions No Specific Medical Conditions or Disease States; No Specific Conditions