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Clinical Trials/NCT03721445
NCT03721445
Unknown
Not Applicable

If Heart Rate Variability Can Predict Continuous Positive Airway Pressure Acceptance and Compliance for Patients With Obstructive Sleep Apnea ?

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation2 sites in 1 country192 target enrollmentOctober 2, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
OSA
Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Enrollment
192
Locations
2
Primary Endpoint
If changes in LF/HF ratio (Low frequency/High frequency ratio) could be a valuable predictor for CPAP acceptance in OSA patients?
Last Updated
7 years ago

Overview

Brief Summary

This study aim to evaluate if the improvement of heart rate variability for the continuous positive airway pressure titration night can predict the short and long term continuous positive airway pressure adherence for patients with moderate to severe OSA.

Detailed Description

Heart rate variability (HRV) represents autonomic regulation and had been used in varies situation, especially the associated with cardiovascular outcomes and psychological diseases. HRV was also well known associated with the severity of obstructive sleep apnea (OSA) and could be improved after adequate treatments for OSA. Continuous positive airway pressure (CPAP) is the first choice of treatment for OSA and had been proved to able to improve HRV in OSA patients. However, the CPAP adherence is always problematic. Many CPAP predictors had been well documented but the HRV is never evaluated to be a potential predictor of CPAP adherence. Therefore, this study will evaluate the changes of HRV for polysomnography (PSG) night, for CPAP titration night to see if the changes of HRV in the CPAP titration night could predict CPAP adherence for OSA patients in Taiwan.

Registry
clinicaltrials.gov
Start Date
October 2, 2018
End Date
March 31, 2021
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mei-Chen Yang

Attending physician

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Eligibility Criteria

Inclusion Criteria

  • aged:20\~75y/o
  • PSG revealed moderate to severe OSA (apnea hypopnea index \[AHI\] ≧15/hour)
  • had been completed CPAP titration test

Exclusion Criteria

  • aged\<20y/o or \>75 y/o
  • mild OSA, (AHI \<15/hour), or no OSA (AHI\<5/hour)
  • unstable cardiopulmonary disease, psychological diseases, using sleep pills.

Outcomes

Primary Outcomes

If changes in LF/HF ratio (Low frequency/High frequency ratio) could be a valuable predictor for CPAP acceptance in OSA patients?

Time Frame: 1 month

Changes of LF/HF ratio between PSG study night and CPAP titration night will be measured and evaluated its association with CPAP acceptance of one month CPAP trial at home in moderate to severe OSA patients.

Secondary Outcomes

  • If CPAP treatment could improve LF/HF ratio after 6 months of treatment in moderate to severe OSA patients?(6 months)

Study Sites (2)

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