This Research Project Studies the Relationship Between OSA and Nocturia.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Ostrava

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients diagnosed obstructive sleep apnoea (OSA )

Apnea-Hypopnea Index (AHI) > 15

ability to fill in the voiding diaries

signed informed consent

Disqualifiers

patients using diuretics

patients with malignancies

pregnancy

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Voiding diary

    Other intervention

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Patients with OSA1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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