Validation of Five Seasons Sleep Tracking Mat for the Diagnosis of Obstructive Sleep Apnea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Five Seasons [5S] Sleep Tracking Mat.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea (OSA). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study will evaluate and compare the diagnostic accuracy and effectiveness of the Five Seasons Sleep Tracking Mat with the gold standard, polysomnography.
Detailed description
Given that obstructive sleep apnea (OSA) imposes a heavy disease burden, conducting effective public screening is regarded as a crucial step in health management and chronic disease prevention. Currently, the diagnosis of OSA relies on polysomnography (PSG) and manual scoring, which are constrained by equipment availability and personnel shortages, resulting in low efficiency, high costs, and scheduling difficulties. Additionally, PSG monitoring requires numerous contact-based sensors, leading to poor patient compliance. The lack of large-scale screening and long-term follow-up further restricts the implementation of standardized and evidence-based treatments. Developing new, effective, low- or zero-burden sleep monitoring devices to minimize sleep disruption while ensuring monitoring accuracy is, therefore, a key direction for future research.
The Five Seasons Sleep Tracking Mat (5S Sleep Tracking Mat) detects heartbeats, respiration, body movements, and snoring using ballistocardiogram (BCG) signals. The device is composed primarily of a control unit, monitoring mat, temperature/humidity sensor, power adapter, and light sensor. During operation, the device accurately captures the impact force of bodily movements at a high sampling rate of 2 kHz. It then uses proprietary signal processing and pre-trained AI models to extract heartbeat and respiratory waveforms, as well as body movements. Additionally, it automatically detects respiratory events, calculates the apnea-hypopnea index (AHI), and determines sleep stages. Since the monitoring mat only needs to be placed under the pillow without requiring direct contact with the body or wearable accessories, it is particularly suitable for home-based, long-term daily sleep monitoring.
In this study, researchers will use the current gold standard, PSG, as a reference to validate the Five Seasons Sleep Tracking Mat for sleep monitoring and OSA-assisted diagnosis.
Interventions
- Diagnostic test Five Seasons [5S] Sleep Tracking Mat
The Five Seasons \[5S\] Sleep Tracking Mat consists of a main control box, monitoring mat, temperature/humidity sensor, power adapter, and light sensor. It utilizes Ballistocardiogram (BCG) technology to detect heartbeat, respiration, body movements, and snoring. The collected data is analyzed by a proprietary pre-trained AI model, enabling automatic detection of respiratory events, calculation of the Apnea-Hypopnea Index (AHI), and sleep stage interpretation. Compared to other sleep monitoring
Primary outcome measures
- Diagnostic sensitivity (AHI = 5) of 5S Sleep Tracking Mat compared to PSG [Time frame: Day 1]
- Diagnostic specificity (AHI = 5) of 5S Sleep Tracking Mat compared to PSG [Time frame: Day 1]
Secondary outcome measures (12)
- Diagnostic sensitivity (AHI = 15) of 5S Sleep Tracking Mat compared to PSG [Time frame: Day 1]
- Diagnostic specificity (AHI = 30) of 5S Sleep Tracking Mat compared to PSG [Time frame: Day 1]
- Diagnostic sensitivity (AHI = 30) of 5S Sleep Tracking Mat compared to PSG [Time frame: Day 1]
- Overall accuracy of 5S Sleep Tracking Mat at AHI = 5 [Time frame: Day 1]
- Overall accuracy of 5S Sleep Tracking Mat at AHI = 15 [Time frame: Day 1]
- Overall accuracy of 5S Sleep Tracking Mat at AHI = 30 [Time frame: Day 1]
- Cohen's kappa of 5S Sleep Tracking Mat at AHI = 5 [Time frame: Day 1]
- Cohen's kappa of 5S Sleep Tracking Mat at AHI = 15 [Time frame: Day 1]
- Cohen's kappa of 5S Sleep Tracking Mat at AHI = 30 [Time frame: Day 1]
- Area under the Receiver Operating Characteristic (ROC) Curve (AUC) at AHI = 5. [Time frame: Day 1]
- Area under the Receiver Operating Characteristic (ROC) Curve (AUC) at AHI = 15. [Time frame: Day 1]
- Area under the Receiver Operating Characteristic (ROC) Curve (AUC) at AHI = 30. [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- Participants between 18 and 70 years, with potential symptoms of snoring at night, daytime sleepiness, or self-reported poor sleep quality, suspected of having OSA.
- Participants who are willing to undergo overnight PSG.
Exclusion criteria
- Participants with presence of severe cardiovascular or cerebrovascular diseases, or significant impairment of liver, kidney, or lung function.
- Participants with concurrent unstable respiratory diseases or other acute-phase respiratory illnesses.
- Participants using, at long term or currently, barbiturates, benzodiazepines, sedatives, or other medications that may affect sleep.
- Participants undergoing continuous positive airway pressure (CPAP) therapy or other sleep-related treatments on the study night.
- Participants coexisting insomnia, parasomnia, or other sleep disorders.
- Participants with psychiatric disorders.
- Participants refusing to sign the informed consent form.
- Participants unable to cooperate with the required examinations.
- Participants with any other conditions deemed unsuitable for inclusion by the investigators.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Shanghai Sixth People's Hospital — Shanghai
Identifiers
NCT: NCT06875479 · 2021ZD0201902-1