---
title: Validation of Five Seasons Sleep Tracking Mat for the Diagnosis of Obstructive Sleep Apnea
nct_id: NCT06875479
overall_status: RECRUITING
sponsor: "Shanghai 6th People's Hospital"
study_type: OBSERVATIONAL
primary_condition: Obstructive Sleep Apnea (OSA)
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06875479.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06875479"
ct_last_update_post_date: 2025-04-16
last_seen_at: "2026-05-12T06:59:03.714Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Validation of Five Seasons Sleep Tracking Mat for the Diagnosis of Obstructive Sleep Apnea

**NCT ID:** [NCT06875479](https://clinicaltrials.gov/study/NCT06875479)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 400
- **Lead Sponsor:** Shanghai 6th People's Hospital
- **Collaborators:** West China Hospital, Second Affiliated Hospital of Soochow University, Dalian Municipal Central Hospital, Third Hospital of Inner Mongolia Autonomous Region, Beijing HuiLongGuan Hospital
- **Conditions:** Obstructive Sleep Apnea (OSA)
- **Start Date:** 2025-04-20
- **Completion Date:** 2025-09-30
- **CT.gov Last Update:** 2025-04-16

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL

```
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.
```

## Interventions

- **Five Seasons [5S] Sleep Tracking Mat** (DIAGNOSTIC_TEST) — 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 devices, it is non-contact and requires no wearable components, making it particularly suitable for long-term, daily home use.

## Primary Outcomes

- **Diagnostic sensitivity (AHI = 5) of 5S Sleep Tracking Mat compared to PSG** _(time frame: Day 1)_ — The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 5 events per hour according to 5S Sleep Tracking Mat in participants with AHI ≥ 5 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic sensitivity of 5S Sleep Tracking Mat will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
- **Diagnostic specificity (AHI = 5) of 5S Sleep Tracking Mat compared to PSG** _(time frame: Day 1)_ — The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 5 events per hour according to 5S Sleep Tracking Mat in participants with AHI ≥ 5 events per hour according to PSG scored with American Academy of Sleep Medicine (AASM) v2.6 Guidelines. The point estimation of diagnostic specificity of 5S Sleep Tracking Mat will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.

## Secondary Outcomes

- **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)_
- **Intra-Class Correlation Coefficient (ICC) of Apnea Hypopnea Index (AHI)** _(time frame: Day 1)_
- **Intra-Class Correlation Coefficient (ICC) of Total Sleep Time (TST)** _(time frame: Day 1)_
- **Intra-Class Correlation Coefficient (ICC) of Sleep Latency (SL)** _(time frame: Day 1)_
- **Intra-Class Correlation Coefficient (ICC) of Wake After Sleep Onset (WASO)** _(time frame: Day 1)_
- **Intra-Class Correlation Coefficient (ICC) of the proportion of the stage 1 and 2 of Non Rapid Eye Movement (NREM) sleep** _(time frame: Day 1)_
- **Intra-Class Correlation Coefficient (ICC) of the proportion of the stage 3 of Non Rapid Eye Movement (NREM) sleep** _(time frame: Day 1)_
- **Intra-Class Correlation Coefficient (ICC) of the proportion of Rapid Eye Movement (REM) sleep** _(time frame: Day 1)_
- **Bland-Altman Limits of Agreement (LOA) of Apnea Hypopnea Index (AHI)** _(time frame: Day 1)_
- **Bland-Altman Limits of Agreement (LOA) of Total Sleep Time (TST)** _(time frame: Day 1)_
- **Bland-Altman Limits of Agreement (LOA) of Sleep Latency (SL)** _(time frame: Day 1)_
- **Bland-Altman Limits of Agreement (LOA) of Wake After Sleep Onset (WASO)** _(time frame: Day 1)_
- **Bland-Altman Limits of Agreement (LOA) of the proportion of the stage 1 and 2 of Non Rapid Eye Movement (NREM) sleep** _(time frame: Day 1)_
- **Bland-Altman Limits of Agreement (LOA) of the proportion of the stage 3 of Non Rapid Eye Movement (NREM) sleep** _(time frame: Day 1)_
- **Bland-Altman Limits of Agreement (LOA) of the proportion of Rapid Eye Movement (REM) sleep** _(time frame: Day 1)_

## Locations (1)

- Shanghai Sixth People's Hospital, Shanghai, Shanghai Municipality, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `locations.shanghai sixth people's hospital|shanghai|shanghai municipality|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06875479*  
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