Sleep Breathing Disorders
Conditions
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.
Interventions
DIAGNOSTIC_TESTSleep Respiratory Monitoring System
Millimeter-Wave radar-based Sleep Respiratory Monitoring System to be used on each participant undergoing PSG
Sponsors
Changsha Tsingray Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
During this study, results of the radar-based Sleep Respiratory Monitoring System are not known by the investigator and outcomes assessor, including the personnel who scores PSG.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Sensitivity (AHI≥5) of Sleep Respiratory Monitoring System (SRMS) Compared with Polysomnography (PSG) | 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) | 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) | 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) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-Class Correlation Coefficient (ICC) of Apnea Hypopnea Index (AHI) | Day 1 | ICC between AHI according to Sleep Respiratory Monitoring System (SRMS) and AHI according to Polysomnography (PSG), using one-way random effects model. |
| Intra-Class Correlation Coefficient (ICC) of Total Sleep Time (TST) | Day 1 | ICC between TST according to Sleep Respiratory Monitoring System (SRMS) and TST according to Polysomnography (PSG), using one-way random effects model. |
| Intra-Class Correlation Coefficient (ICC) of Deep Sleep Proportion | Day 1 | 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. |
| Intra-Class Correlation Coefficient (ICC) of Light Sleep Proportion | Day 1 | 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. |
| Intra-Class Correlation Coefficient (ICC) of Rapid Eye Movement (REM) Sleep Proportion | Day 1 | 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. |
Countries
China
Contacts
Primary ContactJian Guan
Outcome results
None listed