This Research Project Studies the Relationship Between OSA and Nocturia.

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

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

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: Voiding diary

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jiří Hynčica; Phone Number: 2587 0042059737; Email: jiri.hyncica@fno.cz

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 70852
      • Recruiting
      • University Hospital Ostrava
      • Contact: Jiří Hynčica; Phone Number: 2587 0042059737; Email: jiri.hyncica@fno.cz
      • Principal Investigator: Radek Paus Sýkora, MD
      • Sub-Investigator: Jan Krhut, prof.,MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with diagnosed moderate or severe obstructive sleep apnoea (AHI > 15).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with OSA; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Investigators: Principal Investigator: Radek Paus Sýkora, MD, University Hospital Ostrava

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; Lower urinary tract symptoms; Nocturia; Nocturnal polyuria; Voiding diary
• Additional Relevant MeSH Terms: Nervous System Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Nocturia
• Other Study ID Numbers: 468/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share the individual participant data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No