Could HRV be a Valuable Predictor for CPAP Adherence?

• Conditions: Autonomic Dysfunction; OSA; Adherence, Patient; PAP

• Registration Number: NCT03721445
• Lead Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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.

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-02
• Study First Submitted: 2018-10-15
• Study First Submitted QC: 2018-10-24
• Last Update Submitted: 2018-10-24
• Study First Posted: 2018-10-26
• Last Update Posted: 2018-10-26
• Primary Completion: 2020-09-30
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Name	Time	Method
If CPAP treatment could improve LF/HF ratio after 6 months of treatment in moderate to severe OSA patients?	6 months	After CPAP treatments 6 months, PSG examination will be followed-up again. The changes of LF/HF ratio between baseline PSG and 6-months PSG will be measured and be evaluated it's differences between different CPAP usage pattern (no any use in CPAP opponents, suboptimal use in CPAP acceptors and optimal use in CPAP acceptors ).

Trial Locations

Locations (2)

Mei-Chen Yang; 🇨🇳 New Taipei City, Taiwan

Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation; 🇨🇳 New Taipei, Taiwan