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Recruiting
NCT07744854
Development of a Torso Patch Sensor (C-TraQ) as a Companion Device to a Fingertip Sensor (TipTraQ) for Direct Monitoring of Respiratory Effort
Conditions: Sleep Apnea, Obstructives, Sleep Apnea Central
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 180
Sponsor: PranaQ Pte. Ltd.
Location: Taipei Veterans General Hospital Taipei Taiwan
Summary
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
Inclusion Criteria:
* Subjects must be 18 years of age or older.
Exclusion Criteria:
* 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
* Interstitial lung disease
Source: ClinicalTrials.gov (NCT07744854). StuddyBuddy aggregates publicly available trial information.