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

NCT ID: NCT06027372

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-21

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

"LARGAN" ECG Holter

Intervention Type DEVICE

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

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.

"LARGAN" ECG Holter

Intervention Type DEVICE

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

Interventions

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"LARGAN" ECG Holter

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diahn-Warng Perng, PhD

Role: STUDY_DIRECTOR

Taipei Veterans General Hospital, Taiwan

Locations

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Fang-Chi Lin, PhD

Role: CONTACT

+886-937-021-807

Facility Contacts

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Fang-Chi Lin

Role: primary

+886-937-021-807

Other Identifiers

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2020-04-016BC

Identifier Type: -

Identifier Source: org_study_id

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