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Could HRV be a Valuable Predictor for CPAP Adherence?

B

Buddhist Tzu Chi Medical Foundation

Status

Unknown

Conditions

PAP
Adherence, Patient
OSA
Autonomic Dysfunction

Treatments

Device: continuous positive airway pressure

Study type

Observational

Funder types

Other

Identifiers

NCT03721445
07-XD-093

Details and patient eligibility

About

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.

Full 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.

Enrollment

192 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No 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.

Trial design

192 participants in 2 patient groups

CPAP opponent
Description:
CPAP opponent: moderate to severe OSA patients who refused CPAP therapy after PSG study and CPAP titration test.
CPAP acceptor
Description:
CPAP acceptor: moderate to severe OSA patients who accepted CPAP therapy after PSG study and CPAP titration test and had purchased a PAP at home for long term use.
Treatment:
Device: continuous positive airway pressure

Trial contacts and locations

2

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Central trial contact

Mei-Chen Yang Yang, MD; Mei-Chen Yang, MD

Data sourced from clinicaltrials.gov

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