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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorBezmialem Vakif University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 65 years

Diagnosed with OHS by a pulmonologist

For individuals with simple obesity: BMI between 30 and 40 kg/m², Apnea-Hypopnea Index (AHI) < 5 on polysomnography, or STOP-Bang score < 3

Ability to communicate in written and spoken Turkish

Disqualifiers

Presence of any additional severe respiratory disease

Presence of orthopedic, neurological, cardiovascular, or respiratory conditions preventing exercise testing

For individuals with simple obesity: presence of OSAS risk factors such as severe snoring or witnessed apnea

Presence of any psychological or psychiatric disorder that could affect cognitive functions

Trial population

Individuals with Obesity Hypoventilation Syndrome who applied to the Department of Pulmonary Diseases at Istanbul University Istanbul Faculty of Medicine, met the inclusion criteria for the study, and were diagnosed through polysomnographic evaluation by a Pulmonary Disease specialist.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

36 Participants
are grouped into 2 trial groups
Group A: Group ı
Group B: Group II

Trial outcomes

Primary outcomes

1

Incremental Shuttle Walk Test (ISWT)

The ISWT is a field test consisting of 12 levels in which walking speed increases progressively. Participants are required to walk back and forth between two cones placed 10 meters apart, performing at their maximal capacity until symptom limitation. The test will be terminated if the patient is unable to maintain the required pace due to dyspnea, upon reaching maximal heart rate, or if the participant is more than 0.5 m behind the cone at the designated signal. The number of completed shuttles will be recorded, along with pre- and post-test measurements of blood pressure, heart rate, oxygen saturation, and dyspnea and leg fatigue scores using the Modified Borg Scale.

Time frame
At baseline (immediately after informed consent)
2

Montreal Cognitive Assessment (MoCA)

Cognitive functions including selective and sustained attention, information processing speed, short-term memory, and reaction time will be evaluated using standardized tests. To minimize environmental influences, all assessments will be conducted under identical conditions-in a quiet room with consistent physical settings-at the same time of day and by the same researchers for each participant. The MoCA will be used as a cognitive screening tool. It evaluates executive functions, attention and concentration, memory, language, abstract thinking, visuospatial skills, orientation, and calculation. The test takes approximately 10 minutes, and scores are calculated out of 30. A cutoff score of 26 is used; scores below this threshold indicate mild cognitive impairment.

Time frame
At baseline (immediately after informed consent)

Secondary outcomes

1

Six-Minute Walk Test (6MWT)

Submaximal functional exercise capacity will be assessed with the 6MWT following ATS guidelines (86). Participants will be instructed to walk at their own pace along a 30-meter flat corridor for six minutes, covering as much distance as possible. Before the test, participants will rest in a seated position for 10 minutes, after which baseline SpO₂, heart rate, blood pressure, and Modified Borg Scale scores for dyspnea and fatigue will be obtained. The same measurements will be repeated after the test. The six-minute walking distance (6MWD) will be recorded in meters.

Time frame
At baseline (immediately after informed consent)
2

Visual Reaction Time

Reaction time will be assessed using the Simple Visual Reaction Time Task implemented via Inquisit version 6.0, a computer-based software platform that also includes cognitive tests and games. In this test, participants are instructed to press the space bar as quickly as possible when a red circle appears at random intervals (2000-8000 ms) on a white screen. Two sets of 20 trials will be performed, and the average will be calculated. The fastest, slowest, and mean reaction times will be recorded as outcomes.

Time frame
At baseline (immediately after informed consent)
3

Epworth Sleepiness Scale (ESS)

The ESS consists of 8 items assessing the likelihood of dozing off during daily activities. Each item is scored from 0 (never) to 3 (always). A total score ≥10 indicates excessive daytime sleepiness. The Turkish validity and reliability of the scale have been established, with high internal consistency across the eight items (Cronbach's α = 0.80).

Time frame
At baseline (immediately after informed consent)
4

Pittsburgh Sleep Quality Index (PSQI)

The PSQI is a 24-item self-reported questionnaire that evaluates sleep quality and disturbances over the past month (25). Its Turkish version has demonstrated validity and reliability (26). The index consists of seven components-subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction-scored on a scale of 0-3. The sum of these component scores yields a global PSQI score ranging from 0 to 21, with scores \>5 indicating poor sleep quality.

Time frame
At baseline (immediately after informed consent)

Other outcomes

Sponsors and contacts

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Bezmialem Vakif University

Lead sponsor

Istanbul University

Collaborator