Evaluating a new radar-based system for monitoring sleep breathing disorders
A Clinical Trial Evaluating the Effectiveness and Safety of a Millimeter-Wave Radar Based Sleep Respiratory Monitoring System
NA · Beijing Tsingray Technology Co., Ltd. · NCT06038006
This study is testing a new radar system that monitors breathing during sleep without any contact to see if it works as well as the traditional sleep tests for diagnosing breathing disorders.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tsingray Technology Co., Ltd. (industry) |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06038006 on ClinicalTrials.gov |
What this trial studies
This study compares a novel millimeter-wave radar-based Sleep Respiratory Monitoring System with the traditional polysomnography (PSG) for diagnosing sleep breathing disorders. The radar system is designed to be contactless, allowing for more comfortable and accessible monitoring of patients. It collects and analyzes data on breathing, heartbeat, and body movements, while also measuring oxygen saturation and pulse. The effectiveness of this system will be validated by comparing its results with those obtained from PSG.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are willing to undergo both PSG and radar-based monitoring.
Not a fit: Patients with severe cardiovascular, cerebrovascular, liver, kidney, or lung dysfunction, as well as those with unstable respiratory diseases or other acute conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this system could provide a more comfortable and accessible method for diagnosing sleep breathing disorders.
How similar studies have performed: While traditional PSG has been the gold standard, the use of radar-based systems for sleep monitoring is a novel approach that has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants is 18 years of age or older. * Participants is willing to undergo overnight polysomnography and Sleep Respiratory Monitoring System testing. Exclusion Criteria: * 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. * Participants that refuse to sign informed consents. * Participants unable to cooperate with medical examination. * Participants excluded in the opinion of the investigator.
Where this trial is running
Shanghai, Shanghai
- Shanghai Sixth People's Hospital — Shanghai, Shanghai, China (RECRUITING)
Study contacts
- Principal investigator: Shankai Yin — Shanghai 6th People's Hospital
- Study coordinator: Jian Guan
- Email: guanjian0606@sina.com
- Phone: 18930172210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Breathing Disorders