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Evaluation of auto bi-level algorithm to treat pressure intolerance in obstructive sleep apnea

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Abstract

Purpose

The objective of this study was to evaluate whether a new auto-adjusting bi-level algorithm was comparable to a standard method for prescribing bi-level therapy.

Methods

This study was a prospective randomized, double-blinded crossover evaluation of the equivalency of the auto-adjusting bi-level mode (VAuto™) compared to standard bi-level mode, using a pre-determined difference in Apnea–Hypopnea Index (AHI) of five events per hour. Data were obtained during sleep studies performed on two separate nights. Twenty-two subjects met the entry criteria and were enrolled in the study at four investigational sites in the USA.

Results

Mean AHI for the auto-adjusting bi-level mode was 6.2 ± 5.4 events per hour and for the standard bi-level mode 8.3 ± 5.8 events per hour. The AHI for the two modes were clinically equivalent. The difference in median pressure between these two modes was −3.8 cm H2O ± 3.6 (p = 0.0008) in favor of the auto-adjusting bi-level mode. In addition, the maximum pressure was significantly higher in the auto-adjusting bi-level mode (16.0 cm H2O vs. 14.1 cm H2O, p = 0.02).

Conclusions

Our results demonstrated that the auto-adjusting bi-level mode normalized AHI comparable to the standard bi-level mode. The results of this study have several significant implications for the clinical management of sleep apnea. Obstructive sleep apnea (OSA) is a common condition and is associated with untoward complications. Non-compliance with positive airway pressure (PAP) limits the efficacy of the PAP therapy. The auto-adjusting bi-level mode provides a potentially reliable alternative for sleep clinicians faced with prescribing bi-level PAP for non-compliant patients. This study documents that this type of auto-adjusting device provides effective treatment of OSA.

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Acknowledgments

All work was supported by a grant from ResMed Corp. The authors gratefully acknowledge the contributions of all the investigators in the sleep centers who contributed to this study (Swedish Medical Center, Darius Rhodes-Zoroufy, MD; Tristate Sleep Disorder Center, David Berkowitz, MD, Martin B Sharf PhD; St John’s Plaza Sleep Disorders Center, Paul Haberman, MD).

Author information

Authors and Affiliations

  1. Swedish Medical Center, 550 17th Avenue, Suite A20, Seattle, WA, 98122, USA

    Nigel Ball

  2. Gordon and Associates, 1400 Shattuck Ave Ste 5, Berkeley, CA, 94709, USA

    Nancy Gordon

  3. ResMed Corp, 9001 Spectrum Center Blvd., San Diego, CA, 92123, USA

    Eileen Casal

  4. Mayo Clinic, 13400 Shea Boulevard, Scottsdale, AZ, 85259, USA

    James Parish

Authors
  1. Nigel Ball
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  2. Nancy Gordon
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  3. Eileen Casal
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  4. James Parish
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Corresponding author

Correspondence to James Parish.

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Ball, N., Gordon, N., Casal, E. et al. Evaluation of auto bi-level algorithm to treat pressure intolerance in obstructive sleep apnea. Sleep Breath 15, 301–309 (2011). https://doi.org/10.1007/s11325-010-0381-0

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  • DOI: https://doi.org/10.1007/s11325-010-0381-0

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