Heart Rate Variability and Nocturnal Blood Oxygen Saturation in Patients With Idiopathic Pulmonary Fibrosis

Recruiting

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Device: "LARGAN" ECG Holter

• Registration Number: NCT06027372
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

The goal of this observational study is to compare the overnight heart rate variability (HRV) and nocturnal oxygen saturation (SpO2) in patients with idiopathic pulmonary fibrosis (IPF). The main questions it aims to answer are: (1). if there are correlations between pulmonary function test and HRV and overnight SpO2; (2). if HRV and SpO2 can predict the occurrence of acute exacerbation in patients with IPF. Participants will be asked to examine pulmonary function test (including lung volumes and six-minute walk test) and wear pulse oxygenation recorder and "LARGAN" ECG Holter" ("LARGAN HEALTH TECHNOLOGY" Sleep Apnea And Sleep Quality Examination System) during sleep.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-21
• Status Verified: 2023-08
• Primary Completion: 2023-08-27
• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-09-06
• Last Update Submitted: 2023-09-06
• Study First Posted: 2023-09-07
• Last Update Posted: 2023-09-07
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• individuals meet the diagnosis of idiopathic pulmonary fibrosis
• individuals agree to participate this study and sign the informed consent
• individuals have cognitive and behavioral abilities

Exclusion Criteria

• age less than 50 years old
• individuals refuse to participate this study and sign the informed consent
• individuals of unclear consciousness

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IPF patients without acute exacerbation during test period	"LARGAN" ECG Holter	IPF patients completing pulmonary function, overnight SpO2 monitor and "LARGAN" ECG Holter remain stable during test period.
IPF patients with acute exacerbation during test period	"LARGAN" ECG Holter	IPF patients completing pulmonary function, overnight SpO2 monitor and "LARGAN" ECG Holter reqire hospitalization during test period.

Primary Outcome Measures

Name	Time	Method
The correlations between measures of pulmonary function test and heart rate variability	1 day test duration

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan