Efficacy and Safety of Newly Developed Korean Continuous Positive Airway Pressure Treatment in Patients with Obstructive Sleep Apnea Syndrome

Jong In Jeong; Jung Joo Lee; Seonwoo Kim; Su Jin Kim; Sang Duk Hong; Seung Kyu Chung; Hun-Jong Dhong; Hojoong Kim; Hyo Yeol Kim

doi:10.18787/jr.2016.23.1.6

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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

Original Article

J Rhinol 2016;23(1):6-16.

Published online: 10 January 2016

DOI: https://doi.org/10.18787/jr.2016.23.1.6

Efficacy and Safety of Newly Developed Korean Continuous Positive Airway Pressure Treatment in Patients with Obstructive Sleep Apnea Syndrome

Jong In Jeong, MD¹, Jung Joo Lee, MD², Seonwoo Kim, PhD³, Su Jin Kim, MD², Sang Duk Hong, MD², Seung Kyu Chung, MD², Hun-Jong Dhong, MD², Hojoong Kim, MD⁴, Hyo Yeol Kim, MD^2,

¹Department of Otorhinolaryngology, School of Medicine, Keimyung University, Daegu;

²Department of Otorhinolaryngology-Head and Neck Surgery, Seoul;

³Biostatistics Unit, Samsung Biomedical Reserch Institute, Seoul;

⁴Division of Pulmonary and Critical Care Medicine, Department of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea

교신저자：김효열, 06351 서울 강남구 일원로 81 성균관대학교 의과대학 삼성서울병원 이비인후과학교실 Tel: +82-2-3410-1785, Fax: +82-2-3410-3879, E-mail: hysiam.kim@samsung.com

Received 24 August 2015 Revised 18 October 2015 Accepted 4 January 2016

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

Keywords: OSAS, AHI, Efficacy, Safety, Newly developed Korean CPAP.

References

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Fig. 1.

Flow chart of study.

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)
Variable	Participating (n=26)	Participating (n=23)	Full analysis set (n=20)
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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