This Research Project Studies the Relationship Between OSA and Nocturia.

Obstructive Sleep Apnea Clinical Trial

Official title:

The Academic Research Project Studies the Relationship Between Obstructive Sleep Apnoea and the Occurrence of Nocturia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239883
• Other study ID #: 468/2021
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: University Hospital Ostrava
• Contact: Jirí Hyncica
• Phone: 0042059737
• Email: jiri.hyncica[@]fno.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main goal of the study is to explore the relationship between obstructive sleep apnoea and nocturia.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Nocturia
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Voiding diary
The patients with diagnosed OSA will be asked to fill in the voiding diary.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	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.	3 months
Primary	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.	3 months
Secondary	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).	3 months
Secondary	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).	3 months
Secondary	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.	3 months