Clinical trial NCT06875479: Validation of Five Seasons Sleep Tracking Mat for the Diagnosis of Obstructive Sleep Apnea
Official title: Validation of Five Seasons Sleep Tracking Mat for the Diagnosis of Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: Second Affiliated Hospital of Soochow University
name: Dalian Municipal Central Hospital
name: Third Hospital of Inner Mongolia Autonomous Region
name: Beijing HuiLongGuan Hospital
First posted: 2025-03-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age between 18 and 70 years, with potential symptoms of snoring at night, daytime sleepiness, or self-reported poor sleep quality, suspected of having OSA, recruited by department of otorhinolaryncology in collaborative hospitals.

Brief summary: 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.

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.

Primary outcomes:
measure: Diagnostic sensitivity (AHI = 5) of 5S Sleep Tracking Mat compared to PSG
timeFrame: Day 1
measure: Diagnostic specificity (AHI = 5) of 5S Sleep Tracking Mat compared to PSG
timeFrame: Day 1
Secondary outcomes:
measure: Diagnostic sensitivity (AHI = 15) of 5S Sleep Tracking Mat compared to PSG
timeFrame: Day 1
measure: Diagnostic specificity (AHI = 30) of 5S Sleep Tracking Mat compared to PSG
timeFrame: Day 1
measure: Diagnostic sensitivity (AHI = 30) of 5S Sleep Tracking Mat compared to PSG
timeFrame: Day 1
measure: Overall accuracy of 5S Sleep Tracking Mat at AHI = 5
timeFrame: Day 1
measure: Overall accuracy of 5S Sleep Tracking Mat at AHI = 15
timeFrame: Day 1
measure: Overall accuracy of 5S Sleep Tracking Mat at AHI = 30
timeFrame: Day 1
measure: Cohen's kappa of 5S Sleep Tracking Mat at AHI = 5
timeFrame: Day 1
measure: Cohen's kappa of 5S Sleep Tracking Mat at AHI = 15
timeFrame: Day 1
measure: Cohen's kappa of 5S Sleep Tracking Mat at AHI = 30
timeFrame: Day 1
measure: Area under the Receiver Operating Characteristic (ROC) Curve (AUC) at AHI = 5.
timeFrame: Day 1
measure: Area under the Receiver Operating Characteristic (ROC) Curve (AUC) at AHI = 15.
timeFrame: Day 1
measure: Area under the Receiver Operating Characteristic (ROC) Curve (AUC) at AHI = 30.
timeFrame: Day 1
measure: Intra-Class Correlation Coefficient (ICC) of Apnea Hypopnea Index (AHI)
timeFrame: Day 1
measure: Intra-Class Correlation Coefficient (ICC) of Total Sleep Time (TST)
timeFrame: Day 1
measure: Intra-Class Correlation Coefficient (ICC) of Sleep Latency (SL)
timeFrame: Day 1
measure: Intra-Class Correlation Coefficient (ICC) of Wake After Sleep Onset (WASO)
timeFrame: Day 1
measure: Intra-Class Correlation Coefficient (ICC) of the proportion of the stage 1 and 2 of Non Rapid Eye Movement (NREM) sleep
timeFrame: Day 1
measure: Intra-Class Correlation Coefficient (ICC) of the proportion of the stage 3 of Non Rapid Eye Movement (NREM) sleep
timeFrame: Day 1
measure: Intra-Class Correlation Coefficient (ICC) of the proportion of Rapid Eye Movement (REM) sleep
timeFrame: Day 1
measure: Bland-Altman Limits of Agreement (LOA) of Apnea Hypopnea Index (AHI)
timeFrame: Day 1
measure: Bland-Altman Limits of Agreement (LOA) of Total Sleep Time (TST)
timeFrame: Day 1
measure: Bland-Altman Limits of Agreement (LOA) of Sleep Latency (SL)
timeFrame: Day 1
measure: Bland-Altman Limits of Agreement (LOA) of Wake After Sleep Onset (WASO)
timeFrame: Day 1
measure: Bland-Altman Limits of Agreement (LOA) of the proportion of the stage 1 and 2 of Non Rapid Eye Movement (NREM) sleep
timeFrame: Day 1
measure: Bland-Altman Limits of Agreement (LOA) of the proportion of the stage 3 of Non Rapid Eye Movement (NREM) sleep
timeFrame: Day 1
measure: Bland-Altman Limits of Agreement (LOA) of the proportion of Rapid Eye Movement (REM) sleep
timeFrame: Day 1
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
Study officials:
References: