Belépés

NCT07147153Befejeződött

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

Investigation of the Relationship Between Functional Capacity, Sleep Quality, and Cognitive Functions in Individuals With Obesity Hypoventilation Syndrome

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 10.

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Megfigyeléses
Résztvevők száma
36 (tényleges)
Első benyújtás
2025. aug. 19.
Kezdés
2025. jan. 1.
Elsődleges befejezés
2025. szept. 30.
Fő szponzor
Bezmialem Vakif University
Betegségek
Elhízás
NCT-szám
NCT07147153

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Bevont résztvevők: 36
  • 2025. jan. 1. és az elsődleges befejezés (2025. szept. 30.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Más betegség

  • Presence of any additional severe respiratory disease
  • Presence of orthopedic, neurological, cardiovascular, or respiratory conditions preventing exercise testing
  • Presence of any psychological or psychiatric disorder that could affect cognitive functions

Egyéb

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

Kiket keres a vizsgálat

  • 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

Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
Istanbul University, Istanbul Faculty of Medicine
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IstanbulTurkey (Türkiye)Ismeretlen állapot

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