Development of a Torso Patch Sensor (C-TraQ) as a Companion Device to a Fingertip Sensor (TipTraQ) for Direct Monitoring of Respiratory Effort

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPranaQ Pte. Ltd.

About this trial

The existing PranaQ system utilizes a fingertip sensor that captures PPG(Photoplethysmography) and accelerometer data, and its clinical validation is well-established. While PPG alone has shown effectiveness in diagnosing obstructive sleep apnea, its limited data channels restrict comprehensive evaluation. For instance, it struggles to link apnea events with body position or differentiate between central and obstructive sleep apnea.

To address these limitations, the PranaQ system incorporates new sensors, specifically the chest patch sensor, to monitor respiratory movements via accelerometer signals. The additional respiration signal has the potential to improve diagnostic accuracy for apnea through additional information from respiratory effort.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subjects must be 18 years of age or older.

Disqualifiers

Opioids use

Chronic Obstructive Lung Disease, Global Initiative for Chronic Obstructive

Lung Disease (GOLD) categorization 3 or 4

Devastating strokes, with a modified Rankin score (mRS) ≥ 4

Trial population

Patient who is scheduled for a sleep study.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Respiratory Rate

PSG recording estimated respiratory rate as ground truth to compare with the C-TraQ-generated respiratory rate.

Time frame
one night
2

Sleep Position

Sleep Position measured by PSG as ground truth to compare with C-TraQ generated sleep position

Time frame
One night
3

AHI

Technician labeled AHI based on PSG signal to compare with PranaQ system's prediction.

Time frame
One night

Secondary outcomes

Other outcomes

Sponsors and contacts

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