Sleep Breathing DisordersNCT06038006
A Clinical Trial Evaluating the Effectiveness and Safety of a mmWave Radar Based Sleep Respiratory Monitoring System
A study testing Sleep Respiratory Monitoring System in people with Sleep Breathing Disorders, run by Changsha Tsingray Technology Co., Ltd. at 1 site in China.
Trial summary
This study compares the diagnostic capability of a millimeter-wave radar-based Sleep Respiratory Monitoring System to the gold standard polysomnography. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Breathing Disorders
- What is being tested?
- Sleep Respiratory Monitoring System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2023to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants is 18 years of age or older.
- Participants is willing to undergo overnight polysomnography and Sleep Respiratory Monitoring System testing.
Who cannot join
- Participants with severe cardiovascular and cerebrovascular diseases, severe liver, kidney, and lung dysfunction.
- Participants with unstable respiratory diseases, or other diseases in acute phase.
- Long-term or current use of barbiturates, benzodiazepines, sedatives and other drugs that may affect sleep.
- Participants that undergo CPAP treatment during the night of the trial.
- Participants with other sleep disorders, e.g. insomnia.
- Participants with mental disorders.
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- Participants that refuse to sign informed consents.
- Participants unable to cooperate with medical examination.
- Participants excluded in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200025
Jian Guan, 18930172210 ext. +86, guanjian0606@sina.com
Shankai Yin
About this study
Official title: A Clinical Trial Evaluating the Effectiveness and Safety of a Millimeter-Wave Radar Based Sleep Respiratory Monitoring System
This study compares the diagnostic capability of a millimeter-wave radar-based Sleep Respiratory Monitoring System to the gold standard polysomnography.
Read the detailed description
The gold standard for the diagnosis of sleep breathing disorders is polysomnography (PSG), which requires contact sensors, in-lab monitoring and manual scoring by experts, limiting the comfortability of patients and accessibility of diagnosis. A novel contactless millimeter-wave radar-based Sleep Respiratory Monitoring System is developed, in order to assist sleep staging and the diagnosis of sleep breathing disorders.
The Sleep Respiratory Monitoring System is capable of collecting, recording, storing and analyzing breathing, heartbeat, spatial distribution of full-body movements, etc. via a millimeter-wave radar, and oxygen saturation, pulse, etc. via a pulse oximeter. A dedicated algorithm enables the system to detect respiratory events and estimate sleep stages based on the collected data. The device and algorithms are to be validated in this study by comparison with PSG.
- Conditions
- Sleep Breathing Disorders
- Being tested
- Sleep Respiratory Monitoring System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Respiratory Monitoring SystemDiagnostic test
Millimeter-Wave radar-based Sleep Respiratory Monitoring System to be used on each participant undergoing PSG
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | The only arm containing participants of this study. Receives: Diagnostic Test: Sleep Respiratory Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Sensitivity (AHI≥5) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 5 events per hour according to SRMS 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 SRMS 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≥15) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 15 events per hour according to SRMS 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 SRMS 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 Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 30 events per hour according to SRMS 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 SRMS 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 Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
The proportion of participants with Apnea Hypopnea Index (AHI) < 5 events per hour according to SRMS 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 SRMS 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≥15) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
The proportion of participants with Apnea Hypopnea Index (AHI) < 15 events per hour according to SRMS 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 specificity of SRMS 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 Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
The proportion of participants with Apnea Hypopnea Index (AHI) < 30 events per hour according to SRMS 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 SRMS 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 (5)
Intra-Class Correlation Coefficient (ICC) of Apnea Hypopnea Index (AHI)
ICC between AHI according to Sleep Respiratory Monitoring System (SRMS) and 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 TST according to Sleep Respiratory Monitoring System (SRMS) and TST according to Polysomnography (PSG), using one-way random effects model.
Measured: Day 1
Intra-Class Correlation Coefficient (ICC) of Deep Sleep Proportion
ICC between the proportion of deep sleep time in total sleep time (TST) according to Sleep Respiratory Monitoring System (SRMS) and the proportion of stage N3 sleep time in TST according to Polysomnography (PSG), using one-way random effects model.
Measured: Day 1
Intra-Class Correlation Coefficient (ICC) of Light Sleep Proportion
ICC between the proportion of light sleep time in total sleep time (TST) according to Sleep Respiratory Monitoring System (SRMS) and the proportion of stage N1 sleep time plus stage N2 sleep time in TST according to Polysomnography (PSG), using one-way random effects model.
Measured: Day 1
Intra-Class Correlation Coefficient (ICC) of Rapid Eye Movement (REM) Sleep Proportion
ICC between the proportion of REM sleep time in total sleep time (TST) according to Sleep Respiratory Monitoring System (SRMS) and the proportion of stage R sleep time in TST according to Polysomnography (PSG), using one-way random effects model.
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 posted14 Sep 2023
- Study start13 Jul 2023
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Breathing DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changsha Tsingray Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shankai Yin, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038006
- Sponsor's protocol ID
- 20221128
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li CY, Wang W, Huang WJ, Xu HH, Yi HL, Guan J, Li G, Yin SK. [Diagnosis of obstructive sleep apnea by a new radar device: a parallel controlled study evaluating agreement with polysomnographic monitoring]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2024 Aug 7;59(8):857-863. doi: 10.3760/cma.j.cn115330-20231204-00267. Chinese.
PubMed 39193596
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Evaluating the Effectiveness and Safety of a Millimeter-Wave Radar Based Sleep Respiratory Monitoring System
- ClinicalTrials.gov ID
- NCT06038006
- Acronym / sponsor ID
- 20221128
- Conditions
- Sleep Breathing Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Changsha Tsingray Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 14 Sep 2023 (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 compares the diagnostic capability of a millimeter-wave radar-based Sleep Respiratory Monitoring System to the gold standard polysomnography.
Detailed description
The gold standard for the diagnosis of sleep breathing disorders is polysomnography (PSG), which requires contact sensors, in-lab monitoring and manual scoring by experts, limiting the comfortability of patients and accessibility of diagnosis. A novel contactless millimeter-wave radar-based Sleep Respiratory Monitoring System is developed, in order to assist sleep staging and the diagnosis of sleep breathing disorders.
The Sleep Respiratory Monitoring System is capable of collecting, recording, storing and analyzing breathing, heartbeat, spatial distribution of full-body movements, etc. via a millimeter-wave radar, and oxygen saturation, pulse, etc. via a pulse oximeter. A dedicated algorithm enables the system to detect respiratory events and estimate sleep stages based on the collected data. The device and algorithms are to be validated in this study by comparison with PSG.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Diagnostic Test: Sleep Respiratory Monitoring SystemThe only arm containing participants of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants is 18 years of age or older.
- Participants is willing to undergo overnight polysomnography and Sleep Respiratory Monitoring System testing.
Key exclusion criteria (9 listed)
- Participants with severe cardiovascular and cerebrovascular diseases, severe liver, kidney, and lung dysfunction.
- Participants with unstable respiratory diseases, or other diseases in acute phase.
- Long-term or current use of barbiturates, benzodiazepines, sedatives and other drugs that may affect sleep.
- Participants that undergo CPAP treatment during the night of the trial.
- Participants with other sleep disorders, e.g. insomnia.
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 |
|---|---|---|
| Sleep Respiratory Monitoring SystemMillimeter-Wave radar-based Sleep Respiratory Monitoring System to be used on each participant undergoing PSG | Diagnostic test | Participants |
Primary outcome
Diagnostic Sensitivity (AHI≥5) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
Time frame: Day 1
The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 5 events per hour according to SRMS 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 SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
Diagnostic Sensitivity (AHI≥15) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
Time frame: Day 1
The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 15 events per hour according to SRMS 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 SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
Diagnostic Sensitivity (AHI≥30) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
Time frame: Day 1
The proportion of participants with Apnea Hypopnea Index (AHI) ≥ 30 events per hour according to SRMS 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 SRMS 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 Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
Time frame: Day 1
The proportion of participants with Apnea Hypopnea Index (AHI) < 5 events per hour according to SRMS 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 SRMS 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≥15) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
Time frame: Day 1
The proportion of participants with Apnea Hypopnea Index (AHI) < 15 events per hour according to SRMS 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 specificity of SRMS 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≥30) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
Time frame: Day 1
The proportion of participants with Apnea Hypopnea Index (AHI) < 30 events per hour according to SRMS 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 SRMS will be compared to the threshold of 0.8, with the half width of 95% confidence interval being no more than 0.1.
5 secondary outcomes
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 Deep Sleep Proportion
Time frame: Day 1
Intra-Class Correlation Coefficient (ICC) of Light Sleep Proportion
Time frame: Day 1
Intra-Class Correlation Coefficient (ICC) of Rapid Eye Movement (REM) Sleep Proportion
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Derived from this study: PubMed 39193596Li CY, Wang W, Huang WJ, Xu HH, Yi HL, Guan J, Li G, Yin SK. [Diagnosis of obstructive sleep apnea by a new radar device: a parallel controlled study evaluating agreement with polysomnographic monitoring]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2024 Aug 7;59(8):857-863. doi: 10.3760/cma.j.cn115330-20231204-00267. Chinese.
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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. This study is not recruiting at the moment.
Shankai Yin principal investigator
Shanghai 6th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Respiratory Monitoring System in people with Sleep Breathing Disorders, run by Changsha Tsingray Technology Co., Ltd. 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: status not confirmed, as of the sponsor's last update on 14 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Guan (18930172210 ext. +86, guanjian0606@sina.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 Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG) (time frame: Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06038006, which also lists 1 linked publication.
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 14 Sep 2023.