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NCT06027372 Clinical Trial

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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:
Differences in Heart Rate Variability and Nocturnal Blood Oxygen Saturation of Patients With Idiopathic Pulmonary Fibrosis Between at Baseline and During Acute Exacerbation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06027372
Other study ID # 2020-04-016BC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 21, 2020
Est. completion date June 30, 2024

Study information
Verified date August 2023
Source Taipei Veterans General Hospital, Taiwan
Contact Fang-Chi Lin, PhD
Phone +886-937-021-807
Email fclin3@vghtpe.gov.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date June 30, 2024
Est. primary completion date August 27, 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• "LARGAN" ECG Holter
wear "LARGAN" ECG Holter during sleep once after completion of pulmonary function test

Locations
Country Name City State
Taiwan Taipei Veterans General Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The correlations between measures of pulmonary function test and heart rate variability 1 day test duration
See also
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