G47.3 J44.9
Conditions
Interventions
Group 1: Consecutive patients examined in a sleep unit of a pulmonary clinic and diagnosed with overlap syndrome i.e. obstructive sleep apnea-hypopnea syndrome (OSAHS) and chronic obstructive pulmonar
Sponsors
Democritus University of Thrace, Medical School, Greece
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: Consecutive patients diagnosed with both OSAHS (obstructive sleep apnea hypopnea syndrome) and COPD (chronic obstructive pulmonary disease), as assessed by full-overnight polysomnography (PSG) and pulmonary function tests (PFTs), respectively, will be included in the study. Included patients will receive the standard medical care with optimal bronchodilation, according to GOLD 2017 guidelines, and optimal non invasive positive airway pressure treatment (NIV).
Exclusion criteria
Exclusion criteria: 1. Age < 40 years 2. Refusal to participate in the study 3. Inability to understand and cooperate with treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of specific clinical and laboratory findings in patients with sleep apnea hypopnea syndrome (OSAHS) and chronic obstructive pulmonary disease (COPD), (overlap syndrome), one year before and one year after optimal treatment with bronchodilation and non-invasive positive airway pressure ventilation (NIV). Patients will receive the standard medical care, according to GOLD 2017 guidelines, and the optimal non-invasive positive airway pressure (NIV) treatment. The following data will be recorded before and after treatment: a. Number of annual COPD exacerbations and hospitalizations due to all causes, and assessment of symptoms with specific questionnaires, namely the COPD Assessment Test (CAT) and Modified Medical Research Council Dyspnea Scale (mMRC) b. Laboratory findings I. Evaluation of complete blood count (CBC) II. Evaluation of lipid profile (Total cholesterol, HDL-C, LDL-C, Triglycerides) III. Evaluation of diabetic status (fasting glucose and insulin levels, HbA1C) and assessment of Insulin Resistance by Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) and Insulin sensitivity by Quantitative Insulin sensitivity Check Index (QUICKI) IV. Evaluation of renal function with measurement of eGFR, serum Cystatin levels and albuminuria V. Measurement of serum inflammatory biomarkers: levels of high sensitivity CRP (hs-CRP) and fibrinogen VI. Measurement of serum cardiovascular biomarkers: levels of high-sensitivity Troponin levels (hs-Trop), N-terminal pro-brain natriuretic peptide (NT-proBNP), uric acid, d-dimers, and lactate c. Pulmonary Function testing I. Measurement of the following parameters (post-bronchodilation): F?V1, FVC, F?V1/FVC, MMEF25-75%, maximal voluntary ventilation (MVV), lung volumes, single-breath diffusing capacity for carbon monoxide (DLCO), maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP) II. Assessment of arterial blood gases (ABGs) III. 6-minute walking test (6-MWT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigation before and after treatment with non-invasive positive airway pressure (NIV) of: a.comorbidities b.evaluation of quality of life (EQ-5D, Well-being Index, WHO-5), and mental health (Hospital Anxiety and Depression Scale, HADS) c.sleep characteristics with different questionnaires, namely the Epworth Severity Scale (ESS) for excessive daytime sleepiness, the Athens Insomnia Scale (AIS) and the Insomnia Severity Scale (ISI) for insomnia, and the Pittsburgh Sleep Quality Index (PSQI) for sleep quality d.Survival after NIV treatment | — |
Countries
Greece
Contacts
Public ContactAthanasios Voulgaris
Democritus University of Thrace, Medical School, Greece
Outcome results
None listed