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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-13

Study Completion Date

2023-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Sleep Breathing Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

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Participants

The only arm containing participants of this study.

Group Type EXPERIMENTAL

Sleep Respiratory Monitoring System

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Sleep Respiratory Monitoring System

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes