Journal List > J Rhinol > v.23(1) > 1044366

Jeong, Lee, Kim, Kim, Hong, Chung, Dhong, Kim, and Kim: Efficacy and Safety of Newly Developed Korean Continuous Positive Airway Pressure Treatment in Patients with Obstructive Sleep Apnea Syndrome

Abstract

Background and Objectives

Obstructive sleep apnea syndrome(OSAS) is characterized by repeated apnea, hypopnea, and micro-arousals during sleep. Among various treatment modalities of OSAS, continuous positive airway pressure(CPAP) treatment is the most effective and successful. The aim of this study was to compare efficacy and safety of newly developed Korean CPAP with standard CPAP in OSAS patients.

Materials and Method

In total, 20 of 26 recruited OSAS patients completed the study. All subjects first used the standard CPAP for 4 weeks. After an at least 2 week washout period, the subjects used the newly developed CPAP for 4 weeks. Polysomnography, questionnaires associated with sleep, lipid profile, pulmonary function test, cardiac marker, and physical examinations were evaluated at baseline and were followed-up after each treatment.

Results

After treatment with the newly developed CPAP, the apnea-hypopnea index was decreased from 53.2/hr to 2.5/hr and was equivalent to that of the standard CPAP. Most of the changes in questionnaire scores, laboratory findings, and physical examinations after newly developed CPAP treatment were equivalent to those with standard CPAP. No serious adverse events were observed during the study.

Conclusion

The efficacy and safety of a newly developed CPAP are equivalent to those of standard CPAP in OSAS patients.

References

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Fig. 1.
Flow chart of study.
jr-23-6f1.tif
Table 1.
Definitions of equivalence margin for bootstrap method
Variable Equivalence margin
AHI, /hr ±5
PSQI ±3
CSAQLI ±1
SF-36 ±15
ESS ±1
SSS ±3
BSQ ±2
Blood pressure, mm Hg Systolic: ±10
  Diastolic: ±5

AHI: Apnea-hypopnea index, PSQI: Pittsburg sleep quality index, CSAQLI: Calgary Sleep Apnea Quality of Life Index, SF-36: Short form-36, ESS: Epworth sleepiness scale, SSS: Stanford sleepiness scale, BSQ: Berlin snoring questionnaire

Table 2.
Baseline characteristics of subjects
Variable Standard CPAP Newly developed CPAP Full analysis set (n=20)
Participating (n=26) Participating (n=23)
Age, years 47.2±12.7 48.1±12.5 47.4±12.8
Sex, n (%)      
  Male 23 (88.5) 20 (87.0) 18 (90.0)
  Female 3 (11.5) 3 (13.0) 2 (10.0)
Height, cm 169.0±8.0 168.9±8.4 169.2±7.7
Weight, kg 76.3±11.6 76.0±11.9 75.6±11.5
Blood pressure, mm Hg      
  Systolic 123.7±11.3 123.2±9.9 124.0±9.4
  Diastolic 80.7±11.6 79.0±8.1 79.7±8.3
Waist circumference, cm 93.9±7.3 94.0±7.4 93.9±7.2
Neck circumference, cm      
  Supine 41.1±3.1 41.0±3.2 41.3±2.9
  Sitting 39.6±2.8 39.5±2.9 39.8±2.7

CPAP: Continuous positive airway pressure

Table 3.
Analysis of AHI result after 4 weeks CPAP treatment using bootstrap method
Variable AHI, /hr Mean (97.5% CI)* Equivalence margin
Baseline 53.2±24.0    
After 4 weeks standard CPAP 3.0±3.7    
After 4 weeks newly developed CPAP 2.5±2.0 2.5 (1.7∼3.5)  
Changes (After 4 weeks-baseline)      
  Change after standard CPAP –50.2±24.7    
  Change after newly developed CPAP –50.7±24.2    
Difference of change (standard-newly) 0.4±4.0 0.4 (−1.1∼2.5) (−5∼5)

* : The 97.5% confidence interval was estimated from 1000 bootstrapped samples by bootstrap method. CI: confidence interval

Table 4.
Analysis of questionnaires associated with sleep after 4 weeks CPAP treatment using bootstrap method
Variable Result Mean (95% CI)* Equivalence margin
Quality of life      
PSQI      
  Baseline 7.5±2.4    
  After 4 weeks standard CPAP 6.1±3.5    
  After 4 weeks newly developed CPAP 5.1±3.0    
  Changes (after 4 weeks-baseline)      
   Change after standard CPAP –1.4±2.3    
   Change after newly developed CPAP –2.4±2.2    
  Difference of change (standard-newly) 1.0±2.4 1.0 (−0.1∼2.1) (−3∼3)
CSAQLI      
  Baseline 4.51±0.74    
  After 4 weeks standard CPAP 5.29±0.92    
  After 4 weeks newly developed CPAP 5.24±0.79    
  Changes (after 4 weeks-Baseline)      
   Change after Standard CPAP 0.78±0.76    
   Change after newly developed CPAP 0.74±0.63    
  Difference of change (standard-newly) 0.05±0.77 0.05 (−0.35∼0.44) (−1∼1)
SF-36      
  Baseline 48.5±15.5    
  After 4 weeks standard CPAP 54.8±17.2    
  After 4 weeks newly developed CPAP 53.8±16.5    
  Changes (after 4 weeks-baseline)      
   Change after standard CPAP 6.3±10.0    
   Change after newly developed CPAP 5.3±11.1    
  Difference of change (standard-newly) 1.0±13.6 1.0 (−5.4∼7.4) (−15∼15)
Daytime sleepiness      
ESS      
  Baseline 10.5±4.2    
  After 4 weeks standard CPAP 8.1±2.8    
  After 4 weeks newly developed CPAP 8.1±3.9    
  Changes (after 4 weeks-baseline)      
   Change after standard CPAP –2.4±4.8    
   Change after newly developed CPAP –2.4±4.4    
  Difference of change (standard-newly) –0.1±4.1 –0.06 (−2.05∼1.50) (−3∼3)
SSS 2.7±0.8    
wBaseline 2.4±1.0    
  After 4 weeks standard CPAP 2.1±0.7    
  After 4 weeks newly developed CPAP      
  Changes (after 4 weeks-baseline) –0.4±1.3    
   Change after standard CPAP –0.6±1.1    
   Change after newly developed CPAP 0.3±1.3    
  Difference of change (standard-newly)   0.2 (−0.3∼0.8) (−1∼1)
Snoring index      
BSQ      
  Baseline 6.4±2.1    
  After 4 weeks standard CPAP 2.1±2.3    
  After 4 weeks newly developed CPAP 3.9±3.0    
  Changes (after 4 weeks-baseline)      
  Change after standard CPAP –4.3±3.0    
  Change after newly developed CPAP –2.5±2.9    
 Difference of change (standard-newly) –1.8±3.0 –1.8 (−3.5∼-0.1) (−2∼2)

* The 95% confidence interval was estimated from 1000 bootstrapped samples by bootstrap method

Out of lowest equivalence margin. PSQI: Pittsburg sleep quality index, CSAQLI: Calgary sleep apnea quality of life index, SF-36: Short form-36, ESS: Epworth sleepiness scale, SSS: Stanford sleepiness scale, BSQ: Berlin Snoring Questionnaire

Table 5.
Analysis of laboratory results associated with obstructive sleep apnea syndrome after 4 weeks CPAP treatment using bootstrap method
Variable Result Mean (95% CI)* Equivalence margin
Lipid profile, mg/dL      
T-chol      
  Baseline 193.7±37.8    
  After 4 weeks standard CPAP 190.3±29.6    
  After 4 weeks newly developed CPAP 192.55±37.3    
  Changes (after 4 weeks-baseline)      
   Change after standard CPAP –3.4±20.9    
   Change after newly developed CPAP –1.1±20.5    
  Difference of change (standard-newly) –2.3±19.8 –2.3 (−11.6∼7.0) (−38∼38)
LDL-C      
  Baseline 124.3±35.5    
  After 4 weeks standard CPAP 117.95±30.7    
  After 4 weeks newly developed CPAP 119.5±36    
  Changes (after 4 weeks-baseline)      
   Change after standard CPAP –6.35±18.2    
   Change after newly developed CPAP –4.8±20.5    
  Difference of change (standard-newly) –1.55±26.5 –1.6 (−11.5∼10.6) (−52∼52)
TG      
  Baseline 202.2±119    
  After 4 weeks standard CPAP 220.45±123.4    
  After 4 weeks newly developed CPAP 204.05±118.3    
  Changes (after 4 weeks-baseline)      
   Change after standard CPAP 18.25±62.5    
   Change after newly developed CPAP 1.85±105.9    
  Difference of change (standard-newly) 16.4±98.2 16.2 (−20.4∼58.5) (−52∼52)
Pulmonary function test, % of estimated volume      
FVC      
  Baseline 90.05±7.9    
  After 4 weeks standard CPAP 88.85±6.9    
  After 4 weeks newly developed CPAP 87.75±8.5    
  Changes (after 4 weeks-baseline)      
   Change after standard CPAP –1.2±4.3    
   Change after newly developed CPAP –2.3±6    
  Difference of change (standard-newly) 1.1±3.6 1.1 (−0.6∼2.8) (−8∼8)
FEV1      
  Baseline 91.45±12.2    
  After 4 weeks standard CPAP 89.75±10    
  After 4 weeks newly developed CPAP 88.1±12.1    
  Changes (after 4 weeks-baseline)      
   Change after standard CPAP –1.7±6.3    
   Change after newly developed CPAP –3.35±9.9    
  Difference of change (standard-newly) 1.65±5.1 1.6 (−0.8∼3.7) (−10∼10)
Cardiac marker, ng/mL      
NT-proBNP      
  Baseline 20.84±19.28    
  After 4 weeks standard CPAP 19.23±14.36    
  After 4 weeks newly developed CPAP 21.43±45.06    
  Changes (after 4 weeks-baseline)      
   Change after standard CPAP –1.61±14.91    
   Change after newly developed CPAP 0.59±40.22    
  Difference of change (standard-newly) –2.21±40.22 –2.5 (−22.3∼10.1) (−78∼78)

* : The 95% confidence interval was estimated from 1000 bootstrapped samples by bootstrap method

: Out of highest equivalence margin. T-chol: Total cholesterol, LDL-C: Low density lipoprotein cholesterol, TG: Triglyceride, FVC: Forced vital capacity, FEV1: Forced expiratory volume in 1 second, NT-proBNP: N-terminal prohormone of brain natriuretic peptide

Table 6.
Analysis of physical examinations associated with obstructive sleep apnea syndrome after 4 weeks CPAP treatment using bootstrap method
Variable Result Mean (95% CI)* Equivalence margin
Blood pressure, mm Hg      
Systolic      
  Baseline 124.5±11.1    
  After 4 weeks standard CPAP 123.8±9.3    
  After 4 weeks newly developed CPAP 121.6±10.8    
  Changes (after 4 weeks-baseline)      
   Change after standard CPAP –0.8±8.0    
   Change after newly developed CPAP –3.0±10.1    
  Difference of change (standard-newly) 2.2±6.4 2.2 (−0.8∼5.2) (−10.0∼10.0)
Diastolic      
  Baseline 83.2±11.4    
  After 4 weeks standard CPAP 79.3±9.0    
  After 4 weeks newly developed CPAP 76.3±7.2    
  Changes (after 4 weeks-baseline)      
   Change after standard CPAP –3.9±8.5    
   Change after newly developed CPAP –6.9±9.4    
  Difference of change (standard-newly) 3.0±7.7 3.0 (−0.2∼6.2) (−5.0∼5.0)
Body measurement      
Weight, Kg      
  Baseline 76.5±12.3    
  After 4 weeks standard CPAP 76.5±12.0    
  After 4 weeks newly developed CPAP 76.1±12.2    
  Changes (after 4 weeks-baseline)      
   Change after standard CPAP 0.005±1.1    
   Change after newly developed CPAP –0.4±2.1    
  Difference of change (standard-newly) 0.4±1.9 0.4 (−0.5∼1.3) (−4.0∼4.0)
Waist, cm      
  Baseline 94.4±7.7    
  After 4 weeks standard CPAP 94.6±7.5    
  After 4 weeks newly developed CPAP 94.3±7.4    
  Changes (after 4 weeks-baseline)      
   Change after standard CPAP 0.2±2.6    
   Change after newly developed CPAP –0.04±1.2    
  Difference of change (standard-newly) 0.2±2.8 0.3 (−0.7∼1.6) (−6.0∼6.0)
Neck-supine, cm      
  Baseline 41.51±3.11    
  After 4 weeks standard CPAP 41.23±3.19    
  After 4 weeks newly developed CPAP 41.35±3.04    
  Changes (after 4 weeks-baseline)      
   Change after standard CPAP –0.28±0.75    
   Change after newly developed CPAP –0.16±0.89    
  Difference of change (standard-newly) –0.13±0.70 –0.13 (−0.42∼0.19) (−1.38∼1.38)
Neck-sitting, cm      
  Baseline 39.99±2.84    
  After 4 weeks standard CPAP 39.92±3.00    
  After 4 weeks newly developed CPAP 39.75±2.78    
  Changes (after 4 weeks-baseline)      
   Change after standard CPAP –0.07±0.69    
   Change after newly developed CPAP –0.24±0.45    
  Difference of change (standard-newly) 0.17±0.75 0.17 (−0.16∼0.48) (−1.48∼1.48)

* : The 95% confidence interval was estimated from 1,000 bootstrapped samples by bootstrap method

: Out of highest equivalence margin

Table 7.
Adverse events during study
Adverse events ResMed CPAP MEKics CPAP P Total
Severity      
  Mild 3 3 6
  Moderate 1 1 2
  Severe 0 0 0
Related with CPAP      
  No 2 2 4
  Yes 2 2 4
Serious adverse event      
  No 4 4 8
  Yes 0 0 0
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