A Study of Breathing Sound-based Classification of Patients With Breathing Disorders

NCT05868694 | Unknown DMC

• 1 other identifier: YX-2021-061-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep-disordered breathing can damage the cardiovascular system, and may also lead to dysregulation of the autonomic nervous system, endocrine disorders, and hemodynamic changes, causing multi-system and multi-organ damage. Screening for potential central-type patients among patients with respiratory disorders can help provide scientific diagnosis and treatment decisions, thus achieving precise treatment. Currently, research on the identification of sleep-disordered breathing phenotypes is in its infancy. Sleep-disordered breathing phenotypes, such as obstructive and central respiratory events, vary widely among individuals. Compared to indirect methods such as RIP and SpO2, changes in breathing sounds and snoring during sleep can more directly reflect airway obstruction. Different types of sleep-disordered breathing exhibit different characteristics in terms of snoring. Patients with obstructive sleep apnea experience narrowing or blockage of the airway due to relaxation of the throat muscles during sleep, which leads to breathing pauses and hypopnea events, resulting in decreased blood oxygen levels, arousal, and snoring. Central sleep apnea is caused by problems with the brainstem or respiratory control center, leading to breathing pauses. Snoring is usually not very prominent in patients with central sleep apnea. This study aims to screen for potential central-type patients by analyzing upper airway sounds of patients with sleep-disordered breathing, in order to achieve precise treatment.

Conditions

Apnea

Keywords

snoring sounds; respiratory sounds; obstructive apnea; central apnea; heart failure

Outcome Measures

Primary Outcomes (2)

• The accuracy of the binary classification of obstructive apnea and central apnea

  Based on the binary classification of events, obstructive apnea is the negative class and central apnea is the positive class. Accuracy is the ratio of the predicted correct positive plus negative class to the total event.

  3 days

• The recall of the binary classification of obstructive apnea and central apnea

  According to the binary classification of events, obstructive apnea is negative and central apnea is positive. Recall represents the proportion of all positive events in the dataset that the model correctly classifies as positive.

  3 days

Secondary Outcomes (2)

• The accuracy of the patient's apnea detection

  3 days

• The recall of the patient's apnea detection.

  3 days

Other Outcomes (3)

• The patient's sleep efficiency

  3 days

• The accuracy of hypoventilation detection in patients

  3 days

• The recall of hypoventilation detection in patients

  3 days

Study Arms (1)

Group 1

Patients suspected of having obstructive apnea

Diagnostic Test: polysomnography

Interventions

polysomnography DIAGNOSTIC_TEST

Polysomnography is mainly used to diagnose sleep breathing disorders, including sleep apnea syndrome, snoring, upper airway resistance syndrome, and also used for the auxiliary diagnosis of other sleep disorders, such as: narcolepsy, restless legs syndrome, insomnia classification, etc.

Group 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. age between 18 to 75 yrs; 2. Patients diagnosed with apnea syndrome;

You may qualify if:

• the age of the patient is 18-75 years old;
• patients with confirmed PSG with AHI ≥ 5 times/hour, with or without daytime sleepiness, hypertension, and diabetes;
• sleep-disordered breathing has not been treated;
• informed consent of patients

You may not qualify if:

• pregnancy;
• have other diseases that are not suitable for participation in this study

Sponsors & Collaborators

• Huai'an No.1 People's Hospital: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Nanjing University of Science and Technology: collaborator

Study Sites (1)

Department Of Respiratory Medicine,Huai'an First People's Hospital,Nanjing Medical University

Huai'an, Jiangsu, 223300, China

RECRUITING

MeSH Terms

Conditions

Apnea; Respiratory Sounds; Sleep Apnea, Obstructive; Sleep Apnea, Central; Heart Failure

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Biao Xue, Doctor

CONTACT

15850573313; bxue0909@njust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of respiratory Medicine in Huai'an No.1 People's Hospital

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 22, 2023
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)