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The Ora Connect cuff-less blood pressure device compared to standard cuffed non invasive blood pressure (NIBP) in adults undergoing tilt table testing and posture changes and exertion to validate accuracy

The Ora Connect cuff-less blood pressure device compared to standard cuffed non invasive blood pressure (NIBP) in adults undergoing tilt table testing and posture changes and exertion to validate accuracy

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000444381
Enrollment
100
Registered
2026-04-09
Start date
2026-05-01
Completion date
2026-09-01
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study aims to collect blood pressure readings via conventional cuffed BP machines and concurrently collect blood pressure readings cuff-lessly via a novel device called Ora Connect that has been developed by the Zaplutus IQ company. Tilt Table Testing and an alternative Posture and Exertion procedure will be used as these procedures commonly induce a change in blood pressure for the participant. By collecting comparative blood pressure readings, the intent is demonstrate that cuff-less blood pressure is as accurate as cuffed blood pressure.

Interventions

Participants are recruited from two groups: Group A: The participant is scheduled to undergo a clinically indicated tilt table test (TTT) performed by a Cardiologist: or Group B: The participant has been recruited to undergo a Posture and Exertion Procedure. Group A: Tilt Table Test Participants will undergo a standard Tilt Table Test of approximately 60 minutes duration beginning with a pre-test supine baseline. Standard tilt table test monitoring equipment consisting of heart rate (HR) and

Participants are recruited from two groups: Group A: The participant is scheduled to undergo a clinically indicated tilt table test (TTT) performed by a Cardiologist: or Group B: The participant has been recruited to undergo a Posture and Exertion Procedure. Group A: Tilt Table Test Participants will undergo a standard Tilt Table Test of approximately 60 minutes duration beginning with a pre-test supine baseline. Standard tilt table test monitoring equipment consisting of heart rate (HR) and rhythm (ECG) monitoring, and a sphygmomanometer BP cuff on the patient’s right arm will be applied. An Ora Connect device will be applied to the patient’s chest and continuous HR, ECG, and cuff-less blood pressure (BP) recordings will commence. A standard automated oscillometric cuffed NIBP machine will be applied to the patients left arm. The participant will then undergo passive 70° head-up tilt for 20 minutes, with continuous HR and ECG, and BP measurement every two minutes. If insufficient cardiovascular response occurs during the TTT, optional sublingual nitroglycerin is usually administered, followed by continued head-up tilt and monitoring. The session concludes with a recovery period in the supine position, during which vitals are continuously recorded. Termination criteria include syncope/presyncope, severe hypotension, prolonged arrhythmia, participant request, or protocol completion without symptoms. The Ora Connect device will concurrently capture continuous HR, ECG and cuff-less BP data, along with automated oscillometric cuffed NIBP every two minutes, and posture throughout the procedure. Group B: Posture and Exertion Procedure Participants undergoing this procedure will have monitoring applied as per the TTT, with the addition of a TGA approved pulse oximeter (Sp02) to one of their finger’s. Participants complete baseline posture stages (sitting, standing, supine), with continuous device recording and cuffed BP every two minutes. This is followed by a 20–40 minute exertional component involving either handgrip (squeeze of spring grips in both hands) or exercise bike exertion. Cuffed BP and device recordings are maintained throughout exercise and a five-minute recovery period. Ora Connect Device: The device under investigation is a small wireless chest worn device that measures all vital signs concurrently and in real time within the single device.

Sponsors

Zaplutus IQ
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Participants of both Group A and Group B will equally be able to enrolled : • Participants who are healthy and not known to have hypertension • Participants who are known to have hypertension, who may or may not be on medication • Participants who consent to the study, and do not meet any exclusion criteria

Exclusion criteria

For both Group A and Group B: • Pre-existing skin sensitivities or allergies to medical adhesives • Hypertension with a systolic greater than 180mmHg or diastolic greater than 100mmHg • Hypotension with a systolic less than 90mmHg • Resting tachycardia of greater than 100 beats per minute • Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 23, 2026