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Study Title and Description

Effect of CPAP therapy on C-reactive protein and cognitive impairment in patients with obstructive sleep apnea hypopnea syndrome.



Key Questions Addressed
1 KQ 1: What is the efficacy, effectiveness, comparative effectiveness, and harms of CPAP devices to improve long-term health outcomes?
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Primary Publication Information
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TitleData
Title Effect of CPAP therapy on C-reactive protein and cognitive impairment in patients with obstructive sleep apnea hypopnea syndrome.
Author Wu SQ., Liao QC., Xu XX., Sun L., Wang J., Chen R.
Country Department of Respiratory Medicine, Northern Jiangsu People's Hospital, Clinical Medical School, Yangzhou University, Yangzhou, 225001, Jiangsu, China.
Year 2016
Numbers Pubmed ID: 26993342

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: KQ 2
Arms
Number Title Description Comments
1 CPAP
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2 No CPAP conservative treatment (CT) consisting of a home weight loss program following a diet and exercise plan if BMI was> 27 kg/m2; avoidance of sedatives and alcohol consumption; avoidance of fatigue; and avoidance of the supine position during sleep
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Design Details
Question... Follow Up Answer Follow-up Answer
Specific KQ KQ 2a: CPAP vs. no intervention
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KQ 2a: CPAP vs. no intervention
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KQ 2a: CPAP vs. no intervention
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Study Design RCT
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RCT
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RCT
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Country ... Specify Other ... China
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Funder Non-industry (fully)
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Study name
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Start and end years of the Study 2011
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2014
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Inclusion criteria age 30–65 years; resident in an urban area; and >8 years of education.
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Exclusion criteria diagnosis of other sleep disorder complications including central sleep apnea (CSA), restless leg syndrome, rapid eye movement (REM) sleep behavior disorders, periodic limb movement disorders, and narcoleptic spectral disorders, among others; previous treatment for sleep apnea including medical or CPAP intervention; diagnosis incompatible with wearing a CPAP facemask; history of head injury, psychiatric disorder including alcohol or drug abuse, or use of drugs that could interfere with cognitive function; previous or current medical treatment for hypertension, diabetes mellitus, or hyperlipidemia; 6) a history of stroke, chronic heart failure, coronary heart disease, or other severe visceral diseases, which could affect cognitive function and serum C-reactive protein concentration; BMI >35 kg/m2
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Specific population? No (all comers or not specified) Severe OSA
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If NRCS, where (eg, page number) in the record is the analytic method to account for differences between study arms described?
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Note/Comment about Design (or overall study) NRCS with an embedded RCT of treatment.
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If NRCS, what confounders were evaluated (from the Methods section)?
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Mutlicenter (Y/N) No
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Definition of OSA AHI >= 15
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Where (eg, page #) in text is the description of how AHI was measured? third page, left column, "Polysomnographic studies"
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Sleep study setting/monitor type AT BASELINE Sleep lab
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Sleep lab
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Sleep lab
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Eligibility: Minimum AHI (threshold) >=15
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Follow-up AHI measurement ... Define No followup measurement ...
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Power calculation reported (y/n) No
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Location of power calculation description
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Was primary outcome adequately powered (N≥ calculated N) No
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Source of records ... Article(s) PubMed ... 26993342
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Language English
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Was AHI or other measure of OSA severity (or diagnosis) explicitly described as having been validated? ... Citation Yes ... Iber C, Ancoli-Israel S, Chesson AL, Quan SF (2007) The AASM manual for the scoring of sleep and associated events: rules, terminology and technical specifications. American Academy of Sleep Medicine, Westchester, IL
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Baseline Characteristics
Question CPAP No CPAP Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant Age - Continuous data (in years) Mean 49.62
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SD 11.48
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Participant Age - Categorical data No data entered.
≥65 years (%) No data entered.
Comorbidities No data entered.
Time since diagnosis of OSA No data entered.
Note/Comment about baseline characteristics No data entered.
% in an excludable category (must be <10%, except mild cognitive impairment) 33.8 36.8
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Exclusion category (type in the exclusion category below) Scores <26 illustrate mild neurocognitive impairment Scores <26 illustrate mild neurocognitive impairment
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BMI Mean 28.19 Mean 27.88 Mean 28.02
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SD 3.72 SD 3.34 SD 3.49
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P<0.10 btw gps? no P<0.10 btw gps? no P<0.10 btw gps? no
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Neck circumference Mean 41.80 Mean 40.48 Mean 41.05 cm
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SD 3.64 SD 3.00 SD 3.35 cm
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P<0.10 btw gps? P=0.068 P<0.10 btw gps? P=0.068 P<0.10 btw gps? P=0.068
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New diagnosis of OSA (% or NR) 100 100 100
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Prior Non-PAP OSA treatment (% or NR) % 0 % 0 % 0
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Define treatment: No pervious treatment per eligibilty criteria Define treatment: No pervious treatment per eligibilty criteria Define treatment: No pervious treatment per eligibilty criteria
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Prior PAP treatment (% or NR) 0 0 0
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Failed prior treatment (% or NR) 0 0 0
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Disabled (%) No data entered.
Demographics 90.1
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Were the significant (or important) differences at baseline accounted for? No data entered.
Baseline sleep measures 11.82 10.96 60.96
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5.17 5.05 11.35
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36.80
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22.19
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5.37
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22.21
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RERI
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Results & Comparisons


Results Data
P-Value Note
Outcome: Epworth (ESS)      Population: All Participants Between-Arm Comparisons
Time Point Measure CPAP No CPAP Comparison Measure CPAP vs. No CPAP


0 months

N Analyzed 68 68
Mean 11.82 10.96
SD 5.17 5.05
SE


6 months

N Analyzed 68 68 <0.01
Mean 4.81 11.31 Net change
SD 4.15 4.97
SE
P-Value Note P-Value Note
Outcome: Cogn: Executive function measure      Population: All Participants Between-Arm Comparisons
Time Point Measure CPAP No CPAP Comparison Measure CPAP vs. No CPAP


0 months

N Analyzed 68 68
Mean 28.33 28.13
SD 3.21 4.01
SE


6 months

N Analyzed 68 68 0.236
Mean 28.7 28.41 Net difference
SD 1.26 1.91
SE
P-Value Note P-Value Note
Outcome: Cogn: Executive function measure      Population: All Participants Between-Arm Comparisons
Time Point Measure CPAP No CPAP Comparison Measure CPAP vs. No CPAP


0 months

N Analyzed 68 68
Mean 26.18 26.46
SD 2.14 1.95
SE


6 months

N Analyzed 68 68 <0.01
Mean 27.37 26.07 net difference
SD 2.32 1.97
SE


Quality Dimensions
Dimension Value Notes Comments
Random sequence generation (Cochrane) Unsure NR
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Allocation concealment (Cochrane) No Data Unsure
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Participant blinding (Cochrane) Unsure NR
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Personnel/Provider blinding (Cochrane) Unsure NR
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Outcome Assessor blinding (Cochrane) Unsure NR
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Complete outcome data/No loss to follow-up (Cochrane) Yes
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No Selective Reporting (Cochrane) Yes
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No Other Bias (Cochrane) Yes
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No confounding risk (ROBINS-I) Unsure Arm-specific baselines not given
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OSA Defn: AHI Yes
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No Inappropriate (post-intervention) adjustment (ROBINS-I) Yes
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OSA Defn: OSA Yes
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Participant selection (ROBINS-I) Yes
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No Follow-up biases (ROBINS-I) Yes
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Population well-defined (NHLBI) Yes
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Intervention well-defined (NHLBI) Yes
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Outcomes well-defined (NHLBI) Yes
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Comparator well-defined (NHLBI) Yes
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Quality Rating
No quality rating data was found.