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 ?

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.

Study Overview

• Status: Unknown
• Conditions: OSA; Adherence, Patient; Autonomic Dysfunction; PAP
• Intervention / Treatment: Device: continuous positive airway pressure

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 Type: Observational
• Enrollment (Anticipated): 192

Contacts and Locations

• Study Contact: Name: Mei-Chen Yang, MD; Phone Number: 5709 886-66289779; Email: mimimai3461@gmail.com
• Study Contact Backup: Name: Mei-Chen Yang Yang, MD; Phone Number: 5709 886-66289779; Email: mimimai3461@gmail.com

Study Locations

• Taiwan
  • New Taipei, Taiwan, 23143
    • Recruiting
    • Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation
  • New Taipei City, Taiwan, 23142
    • Recruiting
    • Mei-Chen Yang
    • Contact: Mei-Chen Yang, MD; Phone Number: 5709 886066289779; Email: mimimai3461@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

moderate to severe OSA patients proved by PSG study and had been received CPAP titration test and had been prescribed CPAP therapy at home.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CPAP opponent; CPAP opponent: moderate to severe OSA patients who refused CPAP therapy after PSG study and CPAP titration test.
CPAP acceptor; 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.	Device: continuous positive airway pressure; Could the changes of HRV between PSG night and CPAP titration night predict the CPAP adherence?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
If changes in LF/HF ratio (Low frequency/High frequency ratio) could be a valuable predictor for CPAP acceptance in OSA patients?	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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
If CPAP treatment could improve LF/HF ratio after 6 months of treatment in moderate to severe OSA patients?	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 ).	6 months

Collaborators and Investigators

• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Investigators: Principal Investigator: Mei-Chen Yang, MD, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Publications and helpful links

General Publications

• Noda A, Yasuma F, Okada T, Yokota M. Circadian rhythm of autonomic activity in patients with obstructive sleep apnea syndrome. Clin Cardiol. 1998 Apr;21(4):271-6. doi: 10.1002/clc.4960210408.
• Palma JA, Iriarte J, Fernandez S, Alegre M, Valencia M, Artieda J, Urrestarazu E. Long-term continuous positive airway pressure therapy improves cardiac autonomic tone during sleep in patients with obstructive sleep apnea. Clin Auton Res. 2015 Aug;25(4):225-32. doi: 10.1007/s10286-015-0297-7. Epub 2015 May 23.
• Walter LM, Biggs SN, Nisbet LC, Weichard AJ, Hollis SL, Davey MJ, Anderson V, Nixon GM, Horne RS. Improved long-term autonomic function following resolution of sleep-disordered breathing in preschool-aged children. Sleep Breath. 2016 Mar;20(1):309-19. doi: 10.1007/s11325-015-1268-x. Epub 2015 Oct 2.
• Gong X, Huang L, Liu X, Li C, Mao X, Liu W, Huang X, Chu H, Wang Y, Wu W, Lu J. Correlation Analysis between Polysomnography Diagnostic Indices and Heart Rate Variability Parameters among Patients with Obstructive Sleep Apnea Hypopnea Syndrome. PLoS One. 2016 Jun 2;11(6):e0156628. doi: 10.1371/journal.pone.0156628. eCollection 2016.
• Terziyski KV, Draganova AI, Taralov ZZ, Ilchev IS, Kostianev SS. The effect of continuous positive airway pressure on heart rate variability during the night in patients with chronic heart failure and central sleep apnoea. Clin Exp Pharmacol Physiol. 2016 Dec;43(12):1185-1190. doi: 10.1111/1440-1681.12662.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2018
• Primary Completion (ANTICIPATED): September 30, 2020
• Study Completion (ANTICIPATED): March 31, 2021

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (ACTUAL): October 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: 07-XD-093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No