Prediction of Exacerbations and Management of COPD Patients With SAH Based on Millimeter Wave Radar Monitoring

NCT05019911 | Unknown

• 1 other identifier: M2021074
• Study Type: observational
• Target: 922
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD; Sleep Apnea Hypopnea Syndrome; Acute Exacerbation of COPD

Outcome Measures

Primary Outcomes (7)

• 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

  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

Secondary Outcomes (2)

• 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

Study Arms (2)

Patients with COPD alone

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.

Device: Polysomnography; Device: Millimeter wave radar equipment

Patients with COPD combined with sleep apnea hypopnea syndrome

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.

Device: Polysomnography; Device: Millimeter wave radar equipment

Interventions

Polysomnography DEVICE

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; Patients with COPD combined with sleep apnea hypopnea syndrome

Millimeter wave radar equipment DEVICE

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.

Patients with COPD alone; Patients with COPD combined with sleep apnea hypopnea syndrome

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD alone and patients with COPD combined with sleep apnea hypopnea syndrome aged 40 years or older

You may qualify if:

• Clinical diagnosis of COPD in line with Group on Chronic Obstructive Pulmonary disease, Chinese Thoracic Society. Guidelines for the diagnosis and treatment of chronic obstructive pulmonary disease (2013 revised).
• Or with Clinical diagnosis of sleep apnea hypopnea in line with Group on sleep breathing disorders, Chinese Thoracic Society. Guidelines for the diagnosis and treatment of obstructive sleep apnea hypopnea syndrome (2011 revised).
• Aged 40 years or older.
• Must provide informed consent.

You may not qualify if:

• Cognitive disorders.
• Unable to join in the study and so on.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Tsinghua University: collaborator

Study Sites (1)

Tsinghua University

Beijing, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Yahong Chen

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yahong Chen

CONTACT

861082266699; chenyahong@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: August 25, 2021
• Study Start: October 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: October 1, 2022
• Last Updated: August 25, 2021

Record last verified: 2021-06

Locations

CN (1)