The Academic Research Project Studies the Relationship Between Obstructive Sleep Apnoea and the Occurrence of Nocturia.
| Registry | NCT06239883 |
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 100 (Estimated) |
| Sponsor | University Hospital Ostrava (Other) |
| Conditions | Obstructive Sleep Apnea |
| Interventions | Voiding diary (Other) |
| Dates | start 2019-06-01, primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2024-02-02, last updated 2025-05-28 |
| Locations | 1 site in Czechia |
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-Summary
The main goal of the study is to explore the relationship between obstructive sleep apnoea and nocturia.
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+Detailed description
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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Patients with OSA | | Other: Voiding diary | Patients with diagnosed OSA will be included in this study group. |
- Voiding diary (Other): The patients with diagnosed OSA will be asked to fill in the voiding diary.
+Outcome measures
Primary outcomes
- Change in the parameters of sleep apnoea - (apnea-hypopnea index - AHI) [3 months]: 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) [3 months]: 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) [3 months]: 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 [3 months]: 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 [3 months]: 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 [3 months]: 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.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* patients diagnosed obstructive sleep apnoea (OSA )
* Apnea-Hypopnea Index (AHI) > 15
* ability to fill in the voiding diaries
* signed informed consent
Exclusion Criteria:
* patients using diuretics
* patients with malignancies
* pregnancy
+Locations (1)
| Facility | City | Country | Status |
|---|
| University Hospital Ostrava | Ostrava, Moravian-Silesian Region | Czechia | Recruiting |
+Publications
- Berry RB, Brooks R, Gamaldo C, Harding SM, Lloyd RM, Quan SF, Troester MT, Vaughn BV. AASM Scoring Manual Updates for 2017 (Version 2.4). J Clin Sleep Med. 2017 May 15;13(5):665-666. doi: 10.5664/jcsm.6576. No abstract available. PMID 28416048
- Lowenstein L, Kenton K, Brubaker L, Pillar G, Undevia N, Mueller ER, FitzGerald MP. The relationship between obstructive sleep apnea, nocturia, and daytime overactive bladder syndrome in women. Am J Obstet Gynecol. 2008 May;198(5):598.e1-5. doi: 10.1016/j.ajog.2008.02.024. PMID 18455544
- Oztura I, Kaynak D, Kaynak HC. Nocturia in sleep-disordered breathing. Sleep Med. 2006 Jun;7(4):362-7. doi: 10.1016/j.sleep.2005.10.004. Epub 2006 Mar 24. PMID 16564213
- Umlauf MG, Chasens ER, Greevy RA, Arnold J, Burgio KL, Pillion DJ. Obstructive sleep apnea, nocturia and polyuria in older adults. Sleep. 2004 Feb 1;27(1):139-44. doi: 10.1093/sleep/27.1.139. PMID 14998251
- Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704. PMID 8464434
+Investigators
- Radek Paus Sýkora, MD, Principal investigator, University Hospital Ostrava