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

NCT06875479 | Recruiting DMC

• 1 other identifier: 2021ZD0201902-1
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (2)

• Diagnostic sensitivity (AHI = 5) of 5S Sleep Tracking Mat compared to PSG

  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.

  Day 1

• Diagnostic specificity (AHI = 5) of 5S Sleep Tracking Mat compared to PSG

  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.

  Day 1

Secondary Outcomes (26)

• Diagnostic sensitivity (AHI = 15) of 5S Sleep Tracking Mat compared to PSG

  Day 1

• Diagnostic specificity (AHI = 30) of 5S Sleep Tracking Mat compared to PSG

  Day 1

• Diagnostic sensitivity (AHI = 30) of 5S Sleep Tracking Mat compared to PSG

  Day 1

• Overall accuracy of 5S Sleep Tracking Mat at AHI = 5

  Day 1

• Overall accuracy of 5S Sleep Tracking Mat at AHI = 15

  Day 1

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead
• West China Hospital: collaborator
• Second Affiliated Hospital of Soochow University: collaborator
• Dalian Municipal Central Hospital: collaborator
• Third Hospital of Inner Mongolia Autonomous Region: collaborator
• Beijing HuiLongGuan Hospital: collaborator

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Weijun Huang, Dr.

CONTACT

86 18930174480; hellohuangwj@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 13, 2025
• Study Start: April 20, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)