Screening and Early Warning of Chronic Obstructive Pulmonary Disease Combined With Sleep Respiratory Disease Based on Medical Internet of Things

NCT ID: NCT04833725

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 680 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-12-31

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a common disease that endangers people's health, causing severe economic and treatment burdens. Sleep breathing disease, as a complication of COPD, increases the hospitalization rate and mortality of COPD. At present, community doctors have insufficient knowledge of COPD and its complications, and they also lack standardized screening and related disease management capabilities. This trail intends to use IoT medical technology to screen for COPD combined with sleep breathing diseases. It can establish a two-way referral channel between primary community hospitals and higher-level hospitals, which provides early warning services for COPD combined with sleep breathing diseases. This trial explores the impact of sleep breathing disease on COPD's acute exacerbation, which improves the understanding of COPD patients combined with sleep breathing diseases. It also improves COPD management and its complications control at the community-level and reduces COPD patients' potential risks and treatment burdens. It also explores tiered diagnosis and treatment models for COPD, promotes the construction of intelligent IoT infrastructure, and enhances standardized diagnosis and treatment of COPD at the grassroots level in China.

Detailed Description

This study is a multi-center joint study, which mainly consists of two parts. First, a cross-sectional observational study was adopted to recruit patients with stable COPD in multiple centers. The COPD's diagnostic criteria follow diagnostic guidelines in China, and the patients were selected among 40-80 years old. Note that we excluded patients who cannot use IoT's mobile applications and cannot complete sleep monitoring and follow-up visits. All patients collect sleep monitoring information through wearable devices, together with demographic characteristics, pulmonary function tests, blood routines, biochemistry, electrocardiogram, chest radiograph, COPD assessment scale, modified British Medical Research Association dyspnea index, St. George's Quality of Life Questionnaire, Sleep Apnea Clinical Score, Berlin Questionnaire, Epworth Sleepiness Scale, Etc. This study estimates patient health status from the collected information, then diagnoses sleep apnea and calculates sleep apnea prevalence. Specifically, we build standards from the analysis of sleep monitoring information, and we form an OSA screening model by applying machine learning algorithms. Second, we establish a COPD cohort joined with sleep breathing disease, where we select COPD patients meeting the diagnostic criteria for sleep breathing disease. All patients use wearable devices and IoT technology for information collection and data management. We also build the early warning platform, and it allows flexible adjustment on the COPD plan according to individual differences and community differences. This tudy requires followed up visit once a month. By observing the number of hospitalizations, the incidence of acute exacerbations, and other secondary observation indicators of COPD patients, the early warning platform can analyze COPD's acute exacerbations combined with sleep respiratory disease. We develop the disease and prognosis model for COPD patients with SAO by applying machine learning algorithms on the previous platform.

Conditions

COPD; Osa Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD combined with OSA

All patients collect sleep monitoring information through wearable devices, together with demographic characteristics, pulmonary function tests, blood routines, biochemistry, electrocardiogram, chest radiograph, COPD assessment scale, modified British Medical Research Association dyspnea index, St. George's Quality of Life Questionnaire, Sleep Apnea Clinical Score, Berlin Questionnaire, Epworth Sleepiness Scale, Etc. This study estimates patient health status from the collected information, then diagnoses sleep apnea and calculates sleep apnea prevalence.

wearable devices

Intervention Type: DEVICE

All patients use wearable devices and IoT technology for information collection and data management. Specifically, we build standards from the analysis of sleep monitoring information, and we form an OSA screening model by applying machine learning algorithms.

Interventions

wearable devices

All patients use wearable devices and IoT technology for information collection and data management. Specifically, we build standards from the analysis of sleep monitoring information, and we form an OSA screening model by applying machine learning algorithms.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

The diagnostic criteria for COPD are in line with the diagnostic guidelines for COPD in China from 40 to 80 years old.

Exclusion Criteria

Patients who cannot use IoT's mobile applications and cannot complete sleep monitoring and follow-up visits.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Municipal Health Commission

OTHER_GOV

Sponsor Role: collaborator

BOE Technology Group Co. Ltd.

UNKNOWN

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Third Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yahong Chen

Role: primary

chenyahong@vip.sina.com

+8601082266699

References

Pan Z, Liao S, Sun W, Zhou H, Lin S, Chen D, Jiang S, Long H, Fan J, Deng F, Zhang W, Chen B, Wang J, Huang Y, Li J, Chen Y. Screening and early warning system for chronic obstructive pulmonary disease with obstructive sleep apnoea based on the medical Internet of Things in three levels of healthcare: protocol for a prospective, multicentre, observational cohort study. BMJ Open. 2024 Feb 28;14(2):e075257. doi: 10.1136/bmjopen-2023-075257.

Reference Type: DERIVED

PMID: 38418236 (View on PubMed)

Other Identifiers

2020-2Z40917

Identifier Type: -

Identifier Source: org_study_id