Clinical trial NCT03721445: Could HRV be a Valuable Predictor for CPAP Adherence?
Official title: If Heart Rate Variability Can Predict Continuous Positive Airway Pressure Acceptance and Compliance for Patients With Obstructive Sleep Apnea ?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: OSA
Autonomic Dysfunction
PAP
Adherence, Patient
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 192
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: If changes in LF/HF ratio (Low frequency/High frequency ratio) could be a valuable predictor for CPAP acceptance in OSA patients?
timeFrame: 1 month
Secondary outcomes:
measure: If CPAP treatment could improve LF/HF ratio after 6 months of treatment in moderate to severe OSA patients?
timeFrame: 6 months
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Mei-Chen Yang
city: New Taipei
country: Taiwan
facility: Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation
Study officials:
affiliation: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
name: Mei-Chen Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1002/clc.4960210408.
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.
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.
citation: 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.
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.