Obstructive Sleep Apnea (OSA)NCT06875479
Validation of Five Seasons Sleep Tracking Mat for the Diagnosis of Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea (OSA), run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
This study will evaluate and compare the diagnostic accuracy and effectiveness of the Five Seasons Sleep Tracking Mat with the gold standard, polysomnography. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Five Seasons [5S] Sleep Tracking Mat
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2025to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200025
Weijun Huang, Dr., 86 18930174480, hellohuangwj@126.com
About this study
This study will evaluate and compare the diagnostic accuracy and effectiveness of the Five Seasons Sleep Tracking Mat with the gold standard, polysomnography.
Read the 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.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Five Seasons [5S] Sleep Tracking Mat
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Five Seasons [5S] Sleep Tracking MatDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1
Secondary outcomes (26)
Diagnostic sensitivity (AHI = 15) of 5S Sleep Tracking Mat compared to PSG
The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 15 events per hour according to 5S Sleep Tracking Mat in participants with AHI ≥ 15 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.
Measured: Day 1
Diagnostic specificity (AHI = 30) of 5S Sleep Tracking Mat compared to PSG
The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 30 events per hour according to 5S Sleep Tracking Mat in participants with AHI ≥ 30 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.
Measured: Day 1
Diagnostic sensitivity (AHI = 30) of 5S Sleep Tracking Mat compared to PSG
The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 30 events per hour according to 5S Sleep Tracking Mat in participants with AHI ≥ 30 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.
Measured: Day 1
Overall accuracy of 5S Sleep Tracking Mat at AHI = 5
Using an AHI threshold of 5 for true positive and true negative classification, the overall accuracy is the percentage of total cases correctly classified.
Measured: Day 1
Overall accuracy of 5S Sleep Tracking Mat at AHI = 15
Using an AHI threshold of 15 for true positive and true negative classification, the overall accuracy is the percentage of total cases correctly classified.
Measured: Day 1
Overall accuracy of 5S Sleep Tracking Mat at AHI = 30
Using an AHI threshold of 30 for true positive and true negative classification, the overall accuracy is the percentage of total cases correctly classified.
Measured: Day 1
Cohen's kappa of 5S Sleep Tracking Mat at AHI = 5
Using an AHI threshold of 5 for determining true positive or true negative results, Cohen's kappa (κ) is the ratio of the difference between the observed agreement (Pa) and the expected agreement (Pe) to the maximum possible difference. When κ=1, the sleep mat's diagnosis perfectly matches the PSG diagnosis. When κ=0, the agreement is entirely due to random effects. When κ<0, the sleep mat's diagnosis is completely inconsistent with the PSG diagnosis.
Measured: Day 1
Cohen's kappa of 5S Sleep Tracking Mat at AHI = 15
Using an AHI threshold of 15 for determining true positive or true negative results, Cohen's kappa (κ) is the ratio of the difference between the observed agreement (Pa) and the expected agreement (Pe) to the maximum possible difference. When κ=1, the sleep mat's diagnosis perfectly matches the PSG diagnosis. When κ=0, the agreement is entirely due to random effects. When κ<0, the sleep mat's diagnosis is completely inconsistent with the PSG diagnosis.
Measured: Day 1
Cohen's kappa of 5S Sleep Tracking Mat at AHI = 30
Using an AHI threshold of 30 for determining true positive or true negative results, Cohen's kappa (κ) is the ratio of the difference between the observed agreement (Pa) and the expected agreement (Pe) to the maximum possible difference. When κ=1, the sleep mat's diagnosis perfectly matches the PSG diagnosis. When κ=0, the agreement is entirely due to random effects. When κ<0, the sleep mat's diagnosis is completely inconsistent with the PSG diagnosis.
Measured: Day 1
Area under the Receiver Operating Characteristic (ROC) Curve (AUC) at AHI = 5.
The ROC of the 5S Sleep Tracking Mat will be drawn based on PSG diagnostic results. The 95% confidence interval of the AUC will be calculated using model-based estimation, with true positive/negative results determined with an AHI threshold of 5.
Measured: Day 1
Area under the Receiver Operating Characteristic (ROC) Curve (AUC) at AHI = 15.
The ROC of the 5S Sleep Tracking Mat will be drawn based on PSG diagnostic results. The 95% confidence interval of the AUC will be calculated using model-based estimation, with true positive/negative results determined with an AHI threshold of 15.
Measured: Day 1
Area under the Receiver Operating Characteristic (ROC) Curve (AUC) at AHI = 30.
The ROC of the 5S Sleep Tracking Mat will be drawn based on PSG diagnostic results. The 95% confidence interval of the AUC will be calculated using model-based estimation, with true positive/negative results determined with an AHI threshold of 30.
Measured: Day 1
Intra-Class Correlation Coefficient (ICC) of Apnea Hypopnea Index (AHI)
ICC between the AHI according to 5S Sleep Tracking Mat and the AHI according to Polysomnography (PSG), using one-way random effects model.
Measured: Day 1
Intra-Class Correlation Coefficient (ICC) of Total Sleep Time (TST)
ICC between the TST according to 5S Sleep Tracking Mat and the TST according to Polysomnography (PSG), using one-way random effects model.
Measured: Day 1
Intra-Class Correlation Coefficient (ICC) of Sleep Latency (SL)
ICC between the SL according to 5S Sleep Tracking Mat and the SL according to Polysomnography (PSG), using one-way random effects model.
Measured: Day 1
Intra-Class Correlation Coefficient (ICC) of Wake After Sleep Onset (WASO)
ICC between the WASO according to 5S Sleep Tracking Mat and the WASO according to Polysomnography (PSG), using one-way random effects model.
Measured: Day 1
Intra-Class Correlation Coefficient (ICC) of the proportion of the stage 1 and 2 of Non Rapid Eye Movement (NREM) sleep
ICC between the proportion of the stage 1 and 2 of NREM sleep according to 5S Sleep Tracking Mat and the proportion of the stage 1 and 2 of NREM sleep according to Polysomnography (PSG), using one-way random effects model.
Measured: Day 1
Intra-Class Correlation Coefficient (ICC) of the proportion of the stage 3 of Non Rapid Eye Movement (NREM) sleep
ICC between the proportion of the stage 3 of NREM sleep according to 5S Sleep Tracking Mat and the proportion of the stage 3 of NREM sleep according to Polysomnography (PSG), using one-way random effects model.
Measured: Day 1
Intra-Class Correlation Coefficient (ICC) of the proportion of Rapid Eye Movement (REM) sleep
ICC between the proportion of REM sleep according to 5S Sleep Tracking Mat and the proportion of REM sleep according to Polysomnography (PSG), using one-way random effects model.
Measured: Day 1
Bland-Altman Limits of Agreement (LOA) of Apnea Hypopnea Index (AHI)
The mean and difference of AHI according to both 5S Sleep Tracking Mat and PSG are analyzed from the raw data. The Bland-Altman plot is created with the mean on the x-axis and the difference on the y-axis. The mean difference and the 95% limits of agreement (LOA) are calculated based on the plot which must fall within the clinically accepted threshold range.
Measured: Day 1
Bland-Altman Limits of Agreement (LOA) of Total Sleep Time (TST)
The mean and difference of TST according to both 5S Sleep Tracking Mat and PSG are analyzed from the raw data. The Bland-Altman plot is created with the mean on the x-axis and the difference on the y-axis. The mean difference and the 95% limits of agreement (LOA) are calculated based on the plot which must fall within the clinically accepted threshold range.
Measured: Day 1
Bland-Altman Limits of Agreement (LOA) of Sleep Latency (SL)
The mean and difference of SL according to both 5S Sleep Tracking Mat and PSG are analyzed from the raw data. The Bland-Altman plot is created with the mean on the x-axis and the difference on the y-axis. The mean difference and the 95% limits of agreement (LOA) are calculated based on the plot which must fall within the clinically accepted threshold range.
Measured: Day 1
Bland-Altman Limits of Agreement (LOA) of Wake After Sleep Onset (WASO)
The mean and difference of WASO according to both 5S Sleep Tracking Mat and PSG are analyzed from the raw data. The Bland-Altman plot is created with the mean on the x-axis and the difference on the y-axis. The mean difference and the 95% limits of agreement (LOA) are calculated based on the plot which must fall within the clinically accepted threshold range.
Measured: Day 1
Bland-Altman Limits of Agreement (LOA) of the proportion of the stage 1 and 2 of Non Rapid Eye Movement (NREM) sleep
The mean and difference of the proportion of the stage 1 and 2 of NREM sleep according to both 5S Sleep Tracking Mat and PSG are analyzed from the raw data. The Bland-Altman plot is created with the mean on the x-axis and the difference on the y-axis. The mean difference and the 95% limits of agreement (LOA) are calculated based on the plot which must fall within the clinically accepted threshold range.
Measured: Day 1
Bland-Altman Limits of Agreement (LOA) of the proportion of the stage 3 of Non Rapid Eye Movement (NREM) sleep
The mean and difference of the proportion of the stage 3 of NREM sleep according to both 5S Sleep Tracking Mat and PSG are analyzed from the raw data. The Bland-Altman plot is created with the mean on the x-axis and the difference on the y-axis. The mean difference and the 95% limits of agreement (LOA) are calculated based on the plot which must fall within the clinically accepted threshold range.
Measured: Day 1
Bland-Altman Limits of Agreement (LOA) of the proportion of Rapid Eye Movement (REM) sleep
The mean and difference of the proportion of REM sleep according to both 5S Sleep Tracking Mat and PSG are analyzed from the raw data. The Bland-Altman plot is created with the mean on the x-axis and the difference on the y-axis. The mean difference and the 95% limits of agreement (LOA) are calculated based on the plot which must fall within the clinically accepted threshold range.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start20 Apr 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Second Affiliated Hospital of Soochow University, Dalian Municipal Central Hospital, Third Hospital of Inner Mongolia Autonomous Region, Beijing HuiLongGuan Hospital
- Responsible party
- Principal investigator, Weijun Huang, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875479
- Sponsor's protocol ID
- 2021ZD0201902-1
- Status last verified
- Apr 2025
- First submitted
- 9 Mar 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Five Seasons Sleep Tracking Mat for the Diagnosis of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06875479
- Acronym / sponsor ID
- 2021ZD0201902-1
- Conditions
- Obstructive Sleep Apnea (OSA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Collaborators
- West China Hospital, Second Affiliated Hospital of Soochow University, Dalian Municipal Central Hospital, Third Hospital of Inner Mongolia Autonomous Region, Beijing HuiLongGuan Hospital
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Five Seasons [5S] Sleep Tracking MatThe 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. | Diagnostic test | – |
Primary outcome
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.
26 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA), run by Shanghai 6th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weijun Huang, Dr. (86 18930174480, hellohuangwj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic sensitivity (AHI = 5) of 5S Sleep Tracking Mat compared to PSG (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.