Could HRV be a Valuable Predictor for CPAP Adherence?

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03721445

Enrollment

192

Registered

2018-10-26

Start date

2018-10-02

Completion date

2021-03-31

Last updated

2018-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence, Patient, Autonomic Dysfunction, OSA, PAP

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.

Interventions

DEVICEcontinuous positive airway pressure

Could the changes of HRV between PSG night and CPAP titration night predict the CPAP adherence?

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 ).

Countries

Taiwan

Contacts

Primary ContactMei-Chen Yang, MD

mimimai3461@gmail.com886-66289779

Backup ContactMei-Chen Yang Yang, MD