Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients

What Was Tested

This registered phase 3 trial tested Desmopressin.

It had two arms (groups): A: Drug/ Placebo (experimental) and B: Placebo/ Drug (experimental).

Initial phase on Desmopressin and then cross over to placebo on the second phase.

Initial phase on Placebo and then cross over to Desmopressin on the second phase.

The registry classes the interventions as drug.

More on the Plan

Nocturia is one of the commonest urinary symptoms in elderly and in patients with obstructive sleep apnoea (OSA).

According to the International Continence Society (ICS) definition, nocturia is defined as "the complaint that the individual has to wake at night one or more times to void" .

It implies a continuum beginning from what might be considered normal, to a bothersome state.

Bothersome nocturia is a common and age-dependent condition.

Who Took Part

Enrollment: 9 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult male or female patient (aged\</=65 years old). Obstructive sleep apnoea diagnosed by sleep study. Stable treatment on obstructive sleep apnoea and / or LUTS. Nocturia on average more than once per night. Having the ability to communicate and comply with the requirements of the study.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: presence of urethral strictures and neurogenic bladder dysfunction; clinical evidence of bladder stones, bladder tumor or an active urinary tract infection; patient on intermittent self-catheterisation.

How the Study Was Run

Design: randomized, crossover and triple-blind.

Because people in this Desmopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Desmopressin and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Desmopressin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2012-03 with completion listed for 2015-02.

It ran at 1 site in Hong Kong.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in no. of nocturia (time frame: Week 4 and Week 13).

It also tracked 4 secondary outcomes, for example Side effects related to desmopressin, Change in quality of Life - NQOL, Change of quality of Sleep - PSQI and Change in lower urinary tract symptoms - OABSS.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Desmopressin in 9 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.