Primary Objectives: To evaluate the effectiveness in the obesity hypoventilation syndrome (OHS) treatment with non-invasive ventilation (NIV) set manually by polysomnography compared to the same treatment with a respirator with automatic NIV adjustment, analyzing as primary variable PaCO2 and as operational variables dropout rate for medical reasons and mortality. Secondary objectives: cost-effectiveness, clinical and functional improvement in wakefulness and during sleep, quality of life, blood pressure monitoring for 24 hours, incidence and evolution of cardiovascular events and use of health resources. Other objectives: 1) effectiveness of treatments in the following subgroups of patients: gender, age, socioeconomic status, severity of sleep apnea, VNI compliance, quality of life and comorbidities; 2) To evaluate the profile of patients with poor adherence to NIV based on clinical severity, gender, age and socioeconomic status in the whole sample and in both intervention groups.
Method: Prospective, blind researchers, randomized, controlled non-inferiority and cost-effectiveness relationship, with two parallel open groups. 200 OHS patients will be divided into two groups by simple randomization 1:1 and followed for one year. The premise of non-inferiority is -2 at the lower limit of the confidence interval 95% for the change in PCO2 between the arms being assessed by analysis of covariance, adjusted for 2-sided, age, sex, body mass index in intention-to-treat and per-protocol analysis. The cost-effectiveness will be performed by Bayesian techniques with sensitivity analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Manual Group: during a complete polysomnography, adding transcutaneous capnography and the basic ventilators curves, the ventilators setting will be adjusted in order to correct respiratory events and patient-ventilator asyncrony. A 10 hours face-to-face investigator training meeting is programmed before opening the inclusion period.
Automatic Group: the A40 ventilator in the automatic AVAPS mode will be adjusted in order to achieve 8-10 ml/kg of ideal weight.
Juan F. Masa
Cáceres, Spain
Change in PaCO2 between arms
Arterial blood gases while room air breathing expressed in mmHg
Time frame: 1 year
Cost-effectiveness analysis by primary outcome
Cost-effectiveness analysis based on the primary outcome in mmHg Differences in within trial costs will be related with the differences in effectiveness (primary outcome) between arms using a probabilistic Bayesian approach to calculate the cost-effectiveness plane.
Time frame: 1 year
Cost-effectiveness analysis by QALY
Cost-effectiveness analysis based on the quality adjusted life year (QALY) Differences in within trial costs will be related with the differences in effectiveness (QALY) between arms using a probabilistic Bayesian approach to calculate the cost-effectiveness plane.
Time frame: 1 year
Change in subjective daytime sleepiness
Sleepiness evaluated by Epworth sleepiness scale, range from 0 to 24, being 0 the best result and 24 the worst.
Time frame: 1 year
Change in Quality of life measured by Functional Sleep Outcomes of Sleep Questionnaire (FOSQ)
Quality of life measured by Functional Sleep Outcomes of Sleep Questionnaire (FOSQ), range from 0 to 120, being 0 the worst result and 120 the best result .
Time frame: 1 year
Change in Quality of life measured by visual analogical wellbeing scale (VAWS)
Quality of life measured by visual analogical well-being scale (VAWS), range from 0 to 100, being 0 the worst result and 120 the best result .
Time frame: 1 year
Change in Quality of life measured by Euroqol 5D.
Quality of life measured by Euroqol 5D, range from 0 to 1, being 0 the worst result and 1 the best result .
Time frame: 1 year
Change in Quality of life measured by Short Form-36 (SF36), Mental component
Quality of life measured by Short Form-36 (SF36) Mental component,range from 0 to 100, being 0 the worst result and 100 the best result.
Time frame: 1 year
Change in Quality of life measured by Short Form-36 (SF36), Physical component
Quality of life measured by Short Form-36 (SF36) Physical component,range from 0 to 100, being 0 the worst result and 100 the best result.
Time frame: 1 year
Change in Bicarbonate arterial blood concentration
Arterial blood gases while breathing room air expressed in mmol/L
Time frame: 1 year
Change in PaO2
Arterial blood gases while breathing room air expressed PaO2 in mmHg
Time frame: 1 year
Change in pH
Arterial blood gases while breathing room air
Time frame: 1 year
Change in polysomnographic Sleep periods
Standard polysomnography. time of sleep periods (Stage 1,2,3,4 and REM) in minutes.
Time frame: 1 year
Change in Arousal Index
Standard polysomnography, number of arousals per sleep hour
Time frame: 1 year
Change in Apnea-Hypopnea index
Standard polysomnography, number of apneas and hypoapneas per sleep hour
Time frame: 1 year
Change in Oxygen desaturation index
Standard polysomnography, number of 3% or more Oxygen desaturations per sleep hour
Time frame: 1 year
Change in Sleep time with Oxygen saturation below 90%
Standard polysomnography, percentage of sleep time with oxygen saturation below 90%
Time frame: 1 year
Change in polysomnographic parameters: Total Sleep time (TTS)
Standard polysomnography, time in minutes
Time frame: 1 year
Change in the blood pressure monitoring
The blood pressure will be monitored during 24 hours with a Blood Pressure Monitoring device before (baseline) and after intervention (1 year) in both arms measured in mmHg. Change in the mean blood pressure will be compared between arms
Time frame: at baseline and after a year
Incidental cardiovascular events
New hypertension diagnosis or anti-hypertensive treatment, atrial fibrillation, hospitalization for nonfatal myocardial infarction or instable angina, nonfatal stroke or transient ischemic attack or for heart failure episode, and cardiovascular death. Data obtained from official electronic health care databases
Time frame: 1 year
Health care resources utilization: Hospital admission
Hospital admission measured in number of events
Time frame: 1 year
Health care resources utilization: Hospital duration
Hospital duration measured in days of hospitalization
Time frame: 1 year
Health care resources utilization: ICU admission
ICU admission measured in numbers of events
Time frame: 1 year
Health care resources utilization: ICU duration
ICU duration measured in days of UCI admissions
Time frame: 1 year
Health care resources utilization: emergency visits
Emergency visits measured in number of events
Time frame: 1 year
Health care resources utilization: primary care visits
Primary care visits measured in number of events
Time frame: 1 year
Health care resources utilization: specialist visits
Specialist visits measured in number of events
Time frame: 1 year
Incidence of new adverse event
Number of adverse events based in CTCAE v4.0
Time frame: 1 year
Side effects
Incidence or side effects of NIV in follow-up visits: excessive noise, headache, claustrophobia, difficulty in sleep conciliation or maintenance, expiration discomfort.
Time frame: 1 year
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