Functional Capacity, Sleep Quality, and Cognitive Function in Obesity Hypoventilation Syndrome

Brief summary (registry, in English)

Introduction: Obesity Hypoventilation Syndrome (OHS) is defined as the coexistence of obesity (BMI ≥ 30 kg/m²), daytime hypercapnia (PaCO₂ \> 45 mmHg) in the absence of other causes of hypoventilation, and sleep-disordered breathing. OHS represents the most severe form of obesity-related respiratory failure and leads to serious consequences such as increased mortality rates, chronic heart failure, pulmonary hypertension, and hospitalisations due to acute or chronic hypercapnic respiratory failure. Aim: The aim of this study is to evaluate cognitive functions in individuals with OHS and to investigate the relationship between cognitive functions, sleep quality, and functional capacity. A review of the literature indicates that cognitive functions in OHS have not been sufficiently examined, and existing studies mainly focus on cognitive impairment in individuals with obstructive sleep apnea syndrome (OSAS). However, OHS may also cause cognitive deficits, and therefore, patients should be assessed from this perspective. Cognitive impairment may negatively affect participation in pulmonary rehabilitation programs and reduce the benefits gained from such programs. Moreover, psychological conditions such as depression and anxiety may also influence the success of pulmonary rehabilitation. Thus, identifying cognitive impairment and its association with parameters such as functional capacity and sleep quality is of great importance. Early detection of cognitive deficits may provide positive outcomes for both patients and the healthcare system. Methods: The study will include 18 individuals with OHS diagnosed by a pulmonologist through polysomnographic evaluation at the Department of Pulmonology, Istanbul University, Istanbul Faculty of Medicine, along with 18 age- and sex-matched individuals with simple obesity (BMI \>30 kg/m²). All participants will be evaluated at the Department of Pulmonology, Istanbul University, Istanbul Faculty of Medicine. Body composition will be assessed using bioelectrical impedance analysis with the "Tanita BC-545N Body Composition Monitor." Functional exercise capacity will be evaluated with the Incremental Shuttle Walk Test (ISWT) and the Six-Minute Walk Test (6MWT). Cognitive functions and attention will be assessed using the Montreal Cognitive Assessment (MoCA) and the Visual Reaction Time Test. Daytime sleepiness will be measured with the Epworth Sleepiness Scale (ESS), while sleep quality will be evaluated with the Pittsburgh Sleep Quality Index (PSQI). Psychological status will be assessed using the Depression Anxiety Stress Scale (DASS-21). Statistical analyses will be conducted using the Statistical Package for Social Sciences (SPSS, version 21.0). Arithmetic mean, standard deviation (SD), and confidence intervals (CI) will be presented in tables and figures. The Shapiro-Wilk test will be applied to assess the normality of data distribution. For comparisons between the OHS and simple obesity groups, the Independent Samples T-Test will be used for normally distributed data, while the Mann-Whitney U test will be used for non-normally distributed data. Pearson or Spearman correlation analyses will be performed to investigate the relationship between functional capacity, sleep quality, and cognitive functions.

What you commit to

• Study type: Observational
• Participants enrolled: 36
• From 1 Jan 2025 to the primary completion date, 30 Sept 2025
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

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Who the study is looking for

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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