Technology Clinical Resources

Clinical evidence stands behind all of our technologies. The following citations provide clinical validation of efficacy, adherence, patient satisfaction and patient preference.

C-Flex Pressure Relief Technology
Bi-Flex Pressure Relief Technology
A-Flex Pressure Relief Technology
Auto Algorithm

C-FLEX PRESSURE RELIEF TECHNOLOGY

Efficacy
Patients on C-Flex pressure relief technology have shown a 1 hour 42 minute increase in nightly use vs. traditional CPAP after three months.
Aloia, M., et al., Chest 2005. Vol. 1-27, pg. 2085-93.

Patients on C-Flex pressure relief technology were 3.8 times more likely to use their C-Flex device approximately 6 hours a night after 6 months of use.¹

Flexible CPAP with Expiratory Pressure Relief: An In-Laboratory, Polysomnographic Comparison with Conventional CPAP.
- Duntley, S., et al The 2-night study included 15 patients with known OSA and currently receiving CPAP therapy.  Patients were randomized to receive either their traditional CPAP or C-Flex.  On the follow-up night, all patients were placed on the alternate therapy.

Inspiratory Flow Limitation During NREM and REM Sleep Investigated Under CPAP and C-Flex Conditions.
- Penzel, T. Investigated the occurrence of flow limitations during inspiration in different sleep stages using the three pressure relief levels of C-Flex and CPAP.

Comparison of Compliance with Proportional Positive Airway Pressure (C-Flex) to Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea.
- Loube, D., et al Randomized, single-blinded controlled trial study with 4 weeks of C-Flex vs. CPAP.

C-Flex vs. CPAP Comparison Studies
Two independent studies were performed by board-certified sleep clinicians in AASM-accredited sleep centers comparing C-Flex to CPAP.

Automatic Continuous Positive Airway Pressure Delivery with Expiratory Pressure Relief – an In-laboratory Comparison with Conventional Continuous Positive Airway Pressure Therapy.
- Strohl, K., Wylie, P. Evaluated the therapeutic effect of automatic CPAP with early expiratory pressure relief to treat adult obstructive sleep apnea/hypopnea, and the therapeutic efficacy of C-Flex as compared to CPAP

Adherence
Treatment Adherence and Outcomes in Flexible versus Standard Continuous Positive Airway Pressure Therapy
- Aloia, M.S., et al
This study compares adherence, treatment outcomes and attitudes toward the treatment of OSA in patients treated with traditional CPAP versus patients treated on CPAP with C-Flex.

The Efficacy of C-Flex at Improving Treatment Adherence in Obstructive Sleep Apnea (OSA)
- Ruyak, P.S., Aloia, M., et al
This study evaluated newly diagnosed OSA patients’ nightly use of CPAP therapy and C-Flex.

International Multi-Center CPAP Study of Split-Night Titration and Expiratory Pressure Relief – Long Term Effect on Compliance and Subjective Satisfaction*
- Rosenthal, L.R., et al
The study evaluated the impact of C-Flex vs. CPAP on treatment satisfaction and compliance after completion of a split-night titration.

Treatment Adherence and Outcomes in Flexible versus Standard Continuous Positive Airway Pressure
- Aloia, M.S., et al
An independent study funded by the National Institutes of Health and conducted by Brown University compares C-Flex and traditional CPAP on adherence, treatment outcomes and attitudes toward treatment of OSA.

Effect of Expiratory Pressure Relief During Continuous Positive Airway Pressure Therapy on Adherence in a Retrospective Analysis of Recent Clinical Experience.
- Mohan, K.
A retrospective analysis of therapy compliance date was done to determine if C-Flex pressure relived provides a compliance advantage.

Patient Satisfaction
International Multi-Center Long Term Study of Treatment Satisfaction and Compliance in OSA: CPAP with Expiratory Pressure Relief vs. Conventional CPAP*
- Rosenthal, L.R., et al
Six-month randomized single-blind study in which patients received either C-Flex or traditional CPAP therapy. The study evaluated patient satisfaction and compliance to therapy through hours of use per night.

Does Expiratory Pressure Relief Influence Adherence? Multi-Center Trial of C-Flex vs. Conventional CPAP Therapy
- Rosenthal, L.R., et al
Randomized, single blind, controlled study for 180 days of C-Flex vs. traditional CPAP therapy

Patient Preference
Patient Preference Trial
Two patient preference trials using the REMstar Pro with C-Flex were conducted to assess both the patient’s preference for CPAP therapy with C-Flex versus conventional CPAP, and the comfort and ease-of-use of the C-Flex device.

 

Bi-FLEX PRESSURE RELIEF TECHNOLOGY

Adherence
In a study of non-adherent sleep therapy patients, 54% of the patients using Bi-Flex pressure relief technology used their machine > 4 hours per night compared to 32% for traditional CPAP patients.
Gay, P.C., et al., Sleep. Vol. 28. Abstract Supplement 2005, p. A210, #625.

 

A-FLEX PRESSURE RELIEF TECHNOLOGY

Efficacy
A clinical study also shows that the REMstar Auto with A-Flex pressure relief technology maintained effective therapy throughout the night while delivering a mean airway pressure of up to 4cm H20 lower than the mean airway pressure of fixed CPAP titration.¹

Patient Satisfaction
A recent clinical study shows that A-Flex pressure relief technology substantially improves the comfort of positive pressure therapy – patients preferred A-Flex over ordinary CPAP or even CPAP with C-Flex pressure relief technology.^{1, 2}
Advancements to the Event Detection and Control Algorithm in Auto-Adjusting PAP Devices for the Treatment of OSA.

¹ Grover, Sukhdev MD; Sleep Center of Greater Pittsburgh, Pittsburgh, PA
² Wylie, Paul MD; Arkansas Center for Sleep Medicine, Little Rock, AR

 

AUTO ALGORITHM

Efficacy
REMstar Auto with C-Flex is as effective as CPAP at abolishing sleep-related respiratory events
Mulgrew, A., et al.,“Crossover Trial to Determine Efficacy and Patient Satisfaction with AutoCPAP with C-Flex versus Standard CPAP,” Sleep and Breathing 2006. In press.

REMstar Auto significantly improves cognitive function to a level equal to or better than CPAP
Castronovo, V.E., et al., “Cognitive Functioning in Obstructive Sleep Apnea (OSA) Patients: Effect of AutoCPAP and Standard CPAP,” Sleep 2006. Vol. 29, p. A213

In a head-to-head comparison, the REMstar Auto provides better control of the RDI at consistently lower pressure levels throughout the night
Hertegonne, K., et al., “Efficacy of Two Auto-CPAP Devices in
Controlling Sleep Disordered Breathing”, European Respiratory Journal 2005. Vol. 26, p. 111S

REMstar Auto has the lowest effective mean pressure with the most hours of use per night
Nolan, G.M., et al., “Comparison of Three Auto-adjusting Positive Pressure Devices in Patients with Sleep Apnoea”, European Respiratory Journal 2006. Vol. 28, pp. 159-164

REMstar Auto correctly detects and reacts to all types of respiratory events and prevents pressure increases during central events
Abdenbi, F., et al., “Bench Testing of Auto-Adjusting
Positive Airway Pressure Devices”, European Respiratory Journal 2004. Vol. 24, pp. 1-10

Patient Preference
Patients express a preference for the REMstar Auto with C-Flex
Mulgrew, A., et al., “Crossover Trial to Determine Efficacy and Patient Satisfaction with AutoCPAP with C-Flex versus Standard CPAP”, Sleep and Breathing 2006. In press.

The majority of patients prefer treatment with REMstar Auto versus CPAP
Nussbaumer, Y., et al.,“Equivalence of Autoadjusted and Constant Continuous Positive Airway Pressure in Home Treatment of Sleep Apnea”, Chest 2006. Vol. 129, pp. 638-643

REMstar Auto is the easiest to use, the quietest device and the best value for the money. REMstar Auto provides the most restful sleep, the least problems for patients to go to sleep, and the least problems for patients to stay asleep.
Nolan, G.M., et al., “Comparison of Three Auto-adjusting Positive Pressure Devices in Patients with Sleep Apnoea”, European Respiratory Journal 2006. Vol. 28, pp. 159-164