About this trial
The main goal of the study is to explore the relationship between obstructive sleep apnoea and nocturia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients diagnosed obstructive sleep apnoea (OSA )
Apnea-Hypopnea Index (AHI) > 15
ability to fill in the voiding diaries
signed informed consent
Disqualifiers
patients using diuretics
patients with malignancies
pregnancy
Trial population
Adult patients with diagnosed moderate or severe obstructive sleep apnoea (AHI \> 15).
Trial design
Case-only
Prospective
Treatments tested in this trial
Voiding diary
Other interventionThe patients with diagnosed OSA will be asked to fill in the voiding diary.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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).
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).
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.
Sponsors and contacts
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