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Validation of Five Seasons Sleep Tracking Mat for the Diagnosis of Obstructive Sleep Apnea

NCT06875479 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-04-16

No results posted yet for this study

Summary

This study will evaluate and compare the diagnostic accuracy and effectiveness of the Five Seasons Sleep Tracking Mat with the gold standard, polysomnography.

Conditions

  • Obstructive Sleep Apnea (OSA)

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 devices, it is non-contact and requires no wearable components, making it particularly suitable for long-term, daily home use.

Sponsors & Collaborators

  • West China Hospital

    collaborator OTHER

  • Second Affiliated Hospital of Soochow University

    collaborator OTHER

  • Dalian Municipal Central Hospital

    collaborator OTHER

  • Third Hospital of Inner Mongolia Autonomous Region

    collaborator UNKNOWN

  • Beijing HuiLongGuan Hospital

    collaborator OTHER

  • Shanghai 6th People's Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-20
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06875479 on ClinicalTrials.gov