Obstructive Sleep ApneaNCT06239883
This Research Project Studies the Relationship Between OSA and Nocturia.
An observational study of Obstructive Sleep Apnea, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
The main goal of the study is to explore the relationship between obstructive sleep apnoea and nocturia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Voiding diary
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2019to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with diagnosed moderate or severe obstructive sleep apnoea (AHI > 15).
Who may be able to join
- patients diagnosed obstructive sleep apnoea (OSA )
- Apnea-Hypopnea Index (AHI) > 15
- ability to fill in the voiding diaries
- signed informed consent
Who cannot join
- patients using diuretics
- patients with malignancies
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Radek Paus Sýkora, MD
About this study
Official title: 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.
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Voiding diary
- Keywords
- Obstructive Sleep Apnea, Nocturia, Lower urinary tract symptoms, Voiding diary, Nocturnal polyuria
- Medical subject headings
- Sleep Apnea, Obstructive, Nocturia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voiding diaryOther
The patients with diagnosed OSA will be asked to fill in the voiding diary.
| Study group | Role | What they receive |
|---|---|---|
| Patients with OSA | Patients with diagnosed OSA will be included in this study group. Receives: Other: Voiding diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Jun 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Radek Paus Sýkora, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239883
- Sponsor's protocol ID
- 468/2021
- Status last verified
- May 2025
- First submitted
- 12 Jan 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the individual participant data with other researchers.
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 28416048Lowenstein 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 18455544Oztura 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 16564213Umlauf 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 14998251Young 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
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Academic Research Project Studies the Relationship Between Obstructive Sleep Apnoea and the Occurrence of Nocturia.
- ClinicalTrials.gov ID
- NCT06239883
- Acronym / sponsor ID
- 468/2021
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Nocturia, Lower urinary tract symptoms, Voiding diary, Nocturnal polyuria
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of the study is to explore the relationship between obstructive sleep apnoea and nocturia.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with OSA | – | Other: Voiding diaryPatients with diagnosed OSA will be included in this study group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with diagnosed moderate or severe obstructive sleep apnoea (AHI > 15).
Key inclusion criteria (4 listed)
- patients diagnosed obstructive sleep apnoea (OSA )
- Apnea-Hypopnea Index (AHI) > 15
- ability to fill in the voiding diaries
- signed informed consent
Key exclusion criteria (3 listed)
- patients using diuretics
- patients with malignancies
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voiding diaryThe patients with diagnosed OSA will be asked to fill in the voiding diary. | Other | Patients with OSA |
Primary outcome
Change in the parameters of sleep apnoea - (apnea-hypopnea index - AHI)
Time frame: 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)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Change in the data from the voiding diary - functional capacity of the bladder
Time frame: 3 months
Change in the data from the voiding diary - daily diuresis
Time frame: 3 months
Change in the data from the voiding diary - number of voiding episodes
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Background: PubMed 28416048Berry 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.
- Background: PubMed 18455544Lowenstein 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.
- Background: PubMed 16564213Oztura 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.
- Background: PubMed 14998251Umlauf 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.
- Background: PubMed 8464434Young 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.
- Individual participant dataSharing planned: No. There is no plan to share the individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Radek Paus Sýkora, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the parameters of sleep apnoea - (apnea-hypopnea index - AHI) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06239883, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.