An observational study in Sleep Apnea, Obstructives and Sleep Apnea Central, sponsored by PranaQ Pte. Ltd.. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by PranaQ Pte. Ltd. · Observational
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.
Disease Background Sleep apnea-hypopnea syndrome (SAHS) represents a pervasive and significant public health challenge, affecting a substantial segment of the adult population. Epidemiological data indicate that 34% of men and 17% of women between the ages of 30 and 70 are impacted by this condition. Despite its high prevalence, SAHS remains vastly underdiagnosed and consequently undertreated, leaving a large portion of the affected population vulnerable to its associated health risks.
The established gold standard for the definitive diagnosis of sleep apnea is full-channel polysomnography (PSG). This comprehensive diagnostic procedure necessitates the simultaneous recording of a multitude of physiological and biological signals throughout the night, including electroencephalography (EEG) to monitor brain activity and sleep stages, electrooculography (EOG) for eye movements, electromyography (EMG) for muscle activity, and dedicated sensors for airflow, respiratory effort, and blood oxygen saturation.
However, the clinical utility and accessibility of PSG are severely constrained by several inherent limitations. The study is highly uncomfortable, requiring patients to be affixed with a complex array of over 20 sensors and leads. Crucially, PSG is exclusively a hospital-based procedure, confining patients to an unfamiliar environment which can itself negatively impact natural sleep patterns (the "first-night effect"). Furthermore, the subsequent analysis of the multichannel PSG data is resource-intensive, demanding hours of expert technician time for the meticulous labeling and scoring of individual sleep breathing events, which contributes to its high cost, significant time commitment, and impracticality for widespread population screening or routine follow-up evaluation. These barriers highlight the urgent need for more accessible, less burdensome, and cost-effective diagnostic alternatives for sleep apnea.
Description of PranaQ system
The PranaQ system integrates multiple wearable sensors-one for the fingertip and one for the chest-with a mobile application and an interpretable AI platform. The sensors collect the following data:
The PranaQ system, composed of wearable devices and cloud computing, is designed for both home and clinical settings to aid in the evaluation and diagnosis of suspected adult sleep apnea patients, as well as for long-term monitoring. Its function includes recording, storing, and exporting physiological waveforms. After the patient completes the recording, the collected signal data will be sent to the cloud for automatic report generation. The final sleep report will then be sent back to the healthcare provider through a browser-based user interface (PranaQ Expert Panel).
Clinical Evaluation Objectives and Purpose
96 studies on the registry are indexed under Sleep Apnea, Central; 18 are open to participants now.
This study's planned enrollment of 180 is above the median of 148 across 36 observational studies indexed under Sleep Apnea, Central.
Browse Sleep Apnea, Central studies →PranaQ Pte. Ltd. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Compared within Sleep Apnea, Central, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sleep Apnea Syndromes. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patient who is scheduled for a sleep study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Respiratory Rate
PSG recording estimated respiratory rate as ground truth to compare with the C-TraQ-generated respiratory rate.
Time frame: one night
Sleep Position
Sleep Position measured by PSG as ground truth to compare with C-TraQ generated sleep position
Time frame: One night
AHI
Technician labeled AHI based on PSG signal to compare with PranaQ system's prediction.
Time frame: One night
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PranaQ Pte. Ltd.