Clinical trial NCT06038006: A Clinical Trial Evaluating the Effectiveness and Safety of a mmWave Radar Based Sleep Respiratory Monitoring System
Official title: A Clinical Trial Evaluating the Effectiveness and Safety of a Millimeter-Wave Radar Based Sleep Respiratory Monitoring System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Breathing Disorders
Lead sponsor: Beijing Tsingray Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Eligibility 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.

Primary outcomes:
measure: Diagnostic Sensitivity (AHI≥5) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
timeFrame: Day 1
measure: Diagnostic Sensitivity (AHI≥15) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
timeFrame: Day 1
measure: Diagnostic Sensitivity (AHI≥30) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
timeFrame: Day 1
measure: Diagnostic Specificity (AHI≥5) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
timeFrame: Day 1
measure: Diagnostic Specificity (AHI≥15) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
timeFrame: Day 1
measure: Diagnostic Specificity (AHI≥30) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG)
timeFrame: Day 1
Secondary outcomes:
measure: Intra-Class Correlation Coefficient (ICC) of Apnea Hypopnea Index (AHI)
timeFrame: Day 1
measure: Intra-Class Correlation Coefficient (ICC) of Total Sleep Time (TST)
timeFrame: Day 1
measure: Intra-Class Correlation Coefficient (ICC) of Deep Sleep Proportion
timeFrame: Day 1
measure: Intra-Class Correlation Coefficient (ICC) of Light Sleep Proportion
timeFrame: Day 1
measure: Intra-Class Correlation Coefficient (ICC) of Rapid Eye Movement (REM) Sleep Proportion
timeFrame: Day 1
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Shankai Yin
role: PRINCIPAL_INVESTIGATOR
References: