Heart Rate Variability and Nocturnal Blood Oxygen Saturation in Patients With Idiopathic Pulmonary Fibrosis
Differences in Heart Rate Variability and Nocturnal Blood Oxygen Saturation of Patients With Idiopathic Pulmonary Fibrosis Between at Baseline and During Acute Exacerbation
1 other identifier
observational
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2023
CompletedFirst Submitted
Initial submission to the registry
August 31, 2023
CompletedFirst Posted
Study publicly available on registry
September 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedSeptember 7, 2023
August 1, 2023
3.3 years
August 31, 2023
September 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The correlations between measures of pulmonary function test and heart rate variability
1 day test duration
Study Arms (2)
IPF patients with acute exacerbation during test period
IPF patients completing pulmonary function, overnight SpO2 monitor and "LARGAN" ECG Holter reqire hospitalization during test period.
IPF patients without acute exacerbation during test period
IPF patients completing pulmonary function, overnight SpO2 monitor and "LARGAN" ECG Holter remain stable during test period.
Interventions
wear "LARGAN" ECG Holter during sleep once after completion of pulmonary function test
Eligibility Criteria
individuals meet the diagnosis of idiopathic pulmonary fibrosis
You may qualify if:
- 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
You may not qualify if:
- age less than 50 years old
- individuals refuse to participate this study and sign the informed consent
- individuals of unclear consciousness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Veterans General Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Diahn-Warng Perng, PhD
Taipei Veterans General Hospital, Taiwan
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2023
First Posted
September 7, 2023
Study Start
May 21, 2020
Primary Completion
August 27, 2023
Study Completion
June 30, 2024
Last Updated
September 7, 2023
Record last verified: 2023-08