An observational study in Obstructive Sleep Apnea, sponsored by University Hospital Ostrava. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by University Hospital Ostrava · Observational
The main goal of the study is to explore the relationship between obstructive sleep apnoea and nocturia.
The observation study will be performed on patients diagnosed with obstructive sleep apnoea. Patients will undergo routine examination for sleep apnoea and will be asked to fill in voiding diaries for 48 hours. The main goal of the study is to find whether there are any parameters of sleep apnoea associated with occurrence of the nocturia.
Adult patients with diagnosed moderate or severe obstructive sleep apnoea (AHI > 15).
Exclusion Criteria:
Patients with diagnosed OSA will be included in this study group.
Other: Voiding diary
The patients with diagnosed OSA will be asked to fill in the voiding diary.
Change in the parameters of sleep apnoea - (apnea-hypopnea index - AHI)
The change in parameters of sleep apnoea - apnea-hypopnea index (AHI) will be monitored from the baseline to the end of follow-up, before and after the treatment intervention for correction of obstructive sleep apnoea (OSA). The obtained data will be correlated with the information from the voiding diary. The apnea-hypopnea index (AHI) is the combined average number of apneas and hypopneas that occur per hour of sleep. According to the American Academy of Sleep Medicine (AASM) it is categorized into mild (5-15 events/hour), moderate (15-30 events/hour), and severe (\> 30 events/hour).ollow-up, before and after the treatment intervention for correction of obstructive sleep apnoea (OSA). The obtained data will be correlated with the information from the voiding diary.
Time frame: 3 months
Change in the parameters of sleep apnoea - oxygen desaturation index (ODI)
The change in parameters of sleep apnoea - oxygen desaturation index (ODI) will be monitored from the baseline to the end of follow-up, before and after the treatment intervention for correction of obstructive sleep apnoea (OSA). The obtained data will be correlated with the information from the voiding diary. ODI refers to the average number of desaturation episodes occurring per hour, where desaturation episodes are defined as a decrease in the mean oxygen saturation of ≥3% (over the last 120 seconds) that lasts for at least 10 seconds.
Time frame: 3 months
Change in the parameters of sleep apnoea - time under 90% saturation (T90)
The change in parameters of sleep apnoea - time under 90% saturation (T90) will be monitored from the baseline to the end of follow-up, before and after the treatment intervention for correction of obstructive sleep apnoea (OSA). The obtained data will be correlated with the information from the voiding diary. T90 was defined as the proportion of cumulative sleep time with oxygen saturation below 90% in total sleep time. T90≤5% of the total sleep time was classified as light hypoxia, T90 of 5-10% as mild hypoxia,10-25% as moderate hypoxia, and \>25% as severe hypoxia.
Time frame: 3 months
Change in the data from the voiding diary - functional capacity of the bladder
The change in bladder-derived parameters will be monitored from the baseline to the end of follow-up - functional capacity of the bladder will be measured in milliliters (mL).
Time frame: 3 months
Change in the data from the voiding diary - daily diuresis
The change in bladder-derived parameters will be monitored from the baseline to the end of follow-up - daily diuresis will be measured in milliliters (mL).
Time frame: 3 months
Change in the data from the voiding diary - number of voiding episodes
The change in bladder-derived parameters will be monitored from the baseline to the end of follow-up - the number of voiding episodes during sleep will be counted and monitored.
Time frame: 3 months
Plan to share: No — There is no plan to share the individual participant data with other researchers.
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University Hospital Ostrava