Could HRV be a Valuable Predictor for CPAP Adherence?

NCT03721445 | Unknown

• 1 other identifier: 07-XD-093
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 2

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.

Conditions

OSA; Autonomic Dysfunction; PAP; Adherence, Patient

Outcome Measures

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.

  1 month

Secondary Outcomes (1)

• If CPAP treatment could improve LF/HF ratio after 6 months of treatment in moderate to severe OSA patients?

  6 months

Study Arms (2)

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

continuous positive airway pressure DEVICE

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

CPAP acceptor

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• aged:20\~75y/o
• PSG revealed moderate to severe OSA (apnea hypopnea index \[AHI\] ≧15/hour)
• had been completed CPAP titration test

You may not qualify if:

• aged\<20y/o or \>75 y/o
• mild OSA, (AHI \<15/hour), or no OSA (AHI\<5/hour)
• unstable cardiopulmonary disease, psychological diseases, using sleep pills.

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (2)

Mei-Chen Yang

New Taipei City, 23142, Taiwan

RECRUITING

Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation

New Taipei City, 23143, Taiwan

RECRUITING

Related Publications (5)

• 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.

  PMID: 9562937 BACKGROUND

• 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.

  PMID: 26001693 BACKGROUND

• 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.

  PMID: 26432070 BACKGROUND

• 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.

  PMID: 27253187 BACKGROUND

• 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.

  PMID: 27560005 BACKGROUND

MeSH Terms

Conditions

Primary Dysautonomias; Patient Compliance

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Mei-Chen Yang, MD

  Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei-Chen Yang, MD

CONTACT

886-66289779; mimimai3461@gmail.com

Mei-Chen Yang Yang, MD

CONTACT

886-66289779; mimimai3461@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 26, 2018
• Study Start: October 2, 2018
• Primary Completion: September 30, 2020
• Study Completion: March 31, 2021
• Last Updated: October 26, 2018

Record last verified: 2018-10

Locations

TW (2)