Clinical trial NCT06239883: This Research Project Studies the Relationship Between OSA and Nocturia.
Official title: The Academic Research Project Studies the Relationship Between Obstructive Sleep Apnoea and the Occurrence of Nocturia.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Nocturia
Lower urinary tract symptoms
Voiding diary
Nocturnal polyuria
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with diagnosed moderate or severe obstructive sleep apnoea (AHI \> 15).

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the parameters of sleep apnoea - (apnea-hypopnea index - AHI)
timeFrame: 3 months
measure: Change in the parameters of sleep apnoea - oxygen desaturation index (ODI)
timeFrame: 3 months
measure: Change in the parameters of sleep apnoea - time under 90% saturation (T90)
timeFrame: 3 months
Secondary outcomes:
measure: Change in the data from the voiding diary - functional capacity of the bladder
timeFrame: 3 months
measure: Change in the data from the voiding diary - daily diuresis
timeFrame: 3 months
measure: Change in the data from the voiding diary - number of voiding episodes
timeFrame: 3 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Radek Paus Sýkora, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.