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RecruitingNCT06239883Updated May 28, 2025

This Research Project Studies the Relationship Between OSA and Nocturia.

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

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • Obstructive Sleep Apnea
  • Nocturia
  • Lower urinary tract symptoms
  • Voiding diary
  • Nocturnal polyuria
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • patients using diuretics
  • patients with malignancies
  • pregnancy
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with OSA

    Patients with diagnosed OSA will be included in this study group.

    Other: Voiding diary

Interventions

  • OtherVoiding diary

    The patients with diagnosed OSA will be asked to fill in the voiding diary.

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What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

06

Study locations

1 of 1 sites recruiting
  • University Hospital Ostrava
    Ostrava, Moravian-Silesian Region 70852, Czechia
    • Jiří Hynčica · Contact · jiri.hyncica@fno.cz · 0042059737
    • Radek Paus Sýkora, MD · Principal investigator
    • Jan Krhut, prof.,MD,PhD · Sub investigator
    Recruiting
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References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 8464434 ↗

Individual participant data

Plan to share: No — There is no plan to share the individual participant data with other researchers.

08

Registry details

Key details

Study ID
NCT06239883
Lead sponsor
University Hospital Ostrava
Responsible party
Sponsor
First posted
Feb 2, 2024
Start date
Jun 1, 2019
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 28, 2025

Study contacts

Jiří Hynčica
Contact
jiri.hyncica@fno.cz
0042059737 ext. 2587
Radek Paus Sýkora, MD
principal investigator · University Hospital Ostrava

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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