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

Sleep Breathing Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06038006
• Other study ID #: 20221128
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2023
• Est. completion date: November 2023

Study information

• Verified date: September 2023
• Source: Beijing Tsingray Technology Co., Ltd.
• Contact: Jian Guan
• Phone: 18930172210
• Email: guanjian0606[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Aspiration
• Sleep Breathing Disorders

Intervention

Diagnostic Test:
• Sleep Respiratory Monitoring System
Millimeter-Wave radar-based Sleep Respiratory Monitoring System to be used on each participant undergoing PSG

Locations

Country	Name	City	State
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changsha Tsingray Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Primary	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.	Day 1
Primary	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.	Day 1
Primary	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.	Day 1
Primary	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.	Day 1
Primary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1