A Clinical Trial Evaluating the Effectiveness and Safety of a mmWave Radar Based Sleep Respiratory Monitoring System

Tsingray Technology

Status: Enrolling

Conditions: Sleep Breathing Disorders

Treatments: Diagnostic Test: Sleep Respiratory Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06038006

20221128

Details and patient eligibility

About

This study compares the diagnostic capability of a millimeter-wave radar-based Sleep Respiratory Monitoring System to the gold standard polysomnography.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

150 participants in 1 patient group

Participants

Experimental group

Description:

The only arm containing participants of this study.

Treatment:

Diagnostic Test: Sleep Respiratory Monitoring System