This Research Project Studies the Relationship Between OSA and Nocturia.

NCT06239883 | Recruiting

• 1 other identifier: 468/2021
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Sleep Apnea

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in the data from the voiding diary - functional capacity of the bladder

  3 months

• Change in the data from the voiding diary - daily diuresis

  3 months

• Change in the data from the voiding diary - number of voiding episodes

  3 months

Study Arms (1)

Patients with OSA

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

Other: Voiding diary

Interventions

Voiding diary OTHER

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

Patients with OSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• patients diagnosed obstructive sleep apnoea (OSA )
• Apnea-Hypopnea Index (AHI) \> 15
• ability to fill in the voiding diaries
• signed informed consent

You may not qualify if:

• patients using diuretics
• patients with malignancies
• pregnancy

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

Related 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.

  PMID: 28416048 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Nocturia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Radek Paus Sýkora, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 2, 2024
• Study Start: June 1, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)