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Status unknownNCT03721445Updated Oct 26, 2018

Could HRV be a Valuable Predictor for CPAP Adherence?

An observational study in OSA, Autonomic Dysfunction and PAP, sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation. Status unknown at 2 sites in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-26.

Sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Observational

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
192
Ages
20 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • OSA
  • Autonomic Dysfunction
  • PAP
  • Adherence, Patient
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In context

Autonomic Nervous System Diseases

166 studies on the registry are indexed under Autonomic Nervous System Diseases; 36 are open to participants now.

This study's planned enrollment of 192 is above the median of 90 across 51 observational studies indexed under Autonomic Nervous System Diseases.

Browse Autonomic Nervous System Diseases studies →

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation is the lead sponsor of 55 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
192 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • Devicecontinuous positive airway pressure

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month

Secondary outcomes

  1. 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 ).

    Time frame: 6 months

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Study locations

2 of 2 sites recruiting
  • Mei-Chen Yang
    New Taipei City, 23142, Taiwan
    Recruiting
  • Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation
    New Taipei, 23143, Taiwan
    Recruiting
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References and documents

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. PubMed 9562937 ↗
  • 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. PubMed 26001693 ↗
  • 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. PubMed 26432070 ↗
  • 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. PubMed 27253187 ↗
  • 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. PubMed 27560005 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03721445
Lead sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Responsible party
Mei-Chen Yang (Attending physician, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation) — Principal investigator
First posted
Oct 26, 2018
Start date
Oct 2, 2018
Primary completion
Sep 30, 2020 (estimated)
Completion
Mar 31, 2021 (estimated)
Last update
Oct 26, 2018

Study contacts

Mei-Chen Yang, MD
Contact
mimimai3461@gmail.com
886-66289779 ext. 5709
Mei-Chen Yang Yang, MD
Contact
mimimai3461@gmail.com
886-66289779 ext. 5709
Mei-Chen Yang, MD
principal investigator · Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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