Actively Recruiting
Functional Capacity, Sleep Quality, and Cognitive Function in Obesity Hypoventilation Syndrome
Led by Bezmialem Vakif University · Updated on 2025-08-28
36
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
Sponsors
B
Bezmialem Vakif University
Lead Sponsor
I
Istanbul University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Functional Capacity, Sleep Quality, and Cognitive Function in Obesity Hypoventilation Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosed with Obesity Hypoventilation Syndrome (OHS) by a pulmonologist
- For simple obesity group: BMI between 30 and 40 kg/m8, Apnea-Hypopnea Index less than 5 on polysomnography, or STOP-Bang score less than 3
- Able to communicate in written and spoken Turkish
You will not qualify if you...
- Having any other severe respiratory disease
- Having orthopedic, neurological, cardiovascular, or respiratory conditions that prevent exercise testing
- For simple obesity group: presence of obstructive sleep apnea syndrome risk factors such as severe snoring or witnessed apnea
- Having any psychological or psychiatric disorder that could affect cognitive functions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Istanbul University, Istanbul Faculty of Medicine
Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
A
Ayca Arslanturk-Yildirim, Msc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here