NCT05019911|Unknown
Loading search results
Sponsor study identifier
observational
922
1 country
1
Study Start
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Millimeter wave radar will be used to conduct non-contact monitoring continuously for patients' vital signs (eg. respiratory rate, heart rate, and chest/abdominal movement). The monitoring information will be transmitted to the central system through network and displayed in real time. Comparison with polysomnography will be done to examine the consistency between the two devices in diagnosing sleep breathing disorders. The predictive model of acute exacerbations of COPD will be established with the baseline indicators considered.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 29, 2021
Actual (reported)August 25, 2021
Actual (reported)October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Apnea Hypopnea Index in times per hour
AHI will be calculated by dividing times of apnea and hypopnea by hours of evaluation period during sleep. AHI will be monitored by millimeter wave radar devices and polysomnography.
At baseline and millimeter wave radar monitoring continues during one month's or one year's follow-up
Oxygen saturation in percent
Oxygen saturation will be monitored by millimeter wave radar devices, polysomnography or pulse oximeter.
At baseline and millimeter wave radar monitoring and pulse oximeter continues during one month's or one year's follow-up
Respiratory rate in breaths per minute
Respiratory rate will be monitored by millimeter wave radar devices and polysomnography.
At baseline and millimeter wave radar monitoring continues during one month's or one year's follow-up
Heart rate in beats per minute
Heart rate will be monitored by millimeter wave radar devices and polysomnography.
At baseline and millimeter wave radar monitoring continues during one month's or one year's follow-up
Chest/abdominal movement and others
The occurrence of acute exacerbation in patients with COPD combined with sleep apnea hypopnea syndrome
During one month's or one year's follow-up
The time of occurrence of acute exacerbation in patients with COPD combined with sleep apnea hypopnea syndrome
During one month's or one year's follow-up
In the cross-sectional part, the group of patients with COPD alone will be monitored by traditional sleep monitoring equipment (polysomnography) and millimeter wave radar equipment. In the cohort part, this group of patients will be continuously monitored by millimeter wave radar equipment for vital signs combined with pulse oxygen saturation, end expiratory CO2 and other indicators continuously monitored.
In the cross-sectional part, the group of patients with COPD combined with sleep apnea hypopnea syndrome will be monitored by traditional sleep monitoring equipment (polysomnography) and millimeter wave radar equipment. In the cohort part, this group of patients will be continuously monitored by millimeter wave radar equipment for vital signs combined with pulse oxygen saturation, end expiratory CO2 and other indicators continuously monitored.
In the cross-sectional part, the group of patients with COPD alone and the group of patients with COPD combined with sleep apnea hypopnea syndrome will be monitored by traditional sleep monitoring equipment (polysomnography) for vital signs in order to diagnose COPD combined with sleep apnea hypopnea syndrome.
Patients with COPD alone and patients with COPD combined with sleep apnea hypopnea syndrome aged 40 years or older
Tsinghua University
Beijing, China
Yahong Chen
Peking University Third Hospital
First Submitted
June 29, 2021
First Posted
August 25, 2021
Study Start
October 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2021
Estimated (date passed)Predictors of OSA in Patients With COPD
Changes in chest/abdominal movement based on charts or indices and other non-specific measures will be monitored by millimeter wave radar devices or other devices.
At baseline and millimeter wave radar monitoring or other devices continues during one month's or one year's follow-up
Diagnosis of COPD according to lung function
The diagnosis of COPD is made according to the lung function criteria: post-bronchodilator FEV1 (forced expiratory volume at one second): FVC (forced vital capacity) less than 70%.
At baseline
Diagnosis of sleep apnea hypopnea syndrome according to the times of apnea and hypopnea or AHI (RDI) with certain symptoms
The diagnosis of sleep apnea hypopnea syndrome is made according to the times of apnea and hypopnea more than 30 during 7-hour's sleep per night, or AHI is 5 times per hour or more (or using respiratory disturbance index if possible), with primarily obstructive apnea, snore, sleep apnea, and daytime sleepiness.
At baseline
In the cross-sectional part, the group of patients with COPD alone and the group of patients with COPD combined with sleep apnea hypopnea syndrome will be monitored by millimeter wave radar equipment for vital signs in order to diagnose COPD combined with sleep apnea hypopnea syndrome. In the cohort part, both groups of patients will be continuously monitored by millimeter wave radar equipment for vital signs for months in order to establish a model to predict acute exacerbations of COPD combined with sleep apnea hypopnea syndrome.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 25, 2021
Record last verified: 2021-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: