Could HRV be a Valuable Predictor for CPAP Adherence?

OSA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03721445
• Other study ID #: 07-XD-093
• Status: Recruiting
• Start date: October 2, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: October 2018
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: Mei-Chen Yang, MD
• Phone: 886-66289779
• Email: mimimai3461[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: March 31, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adherence, Patient
• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• OSA
• PAP
• Primary Dysautonomias

Intervention

Device:
• continuous positive airway pressure
Could the changes of HRV between PSG night and CPAP titration night predict the CPAP adherence?

Locations

Country	Name	City	State
Taiwan	Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation	New Taipei
Taiwan	Mei-Chen Yang	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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