Daytime Impact Sleep Study

What Was Tested

The trial (phase 2) is built around Desmopressin.

This trial will investigate the relationship of sleep, daytime performance and nocturia in patients treated with Desmopressin or placebo.

Male and Female patients will be administered Desmopressin or Placebo every day for 3 months.

It had three arms (groups): Experimental A (experimental), Experimental B (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 5 actual participants took part.

It was open to people of any sex aged from 25 years up to 65 years.

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

Examples of who could join: At least 2 night time voids per night. Habitual sleep of 6-9.5 hours per night. Experiencing symptoms of Nocturia greater than 6 months.

The full record lists 3 inclusion and 15 exclusion criteria; among the exclusions: greater than 10 night time voids; history of sleep apnoea and plms (periodic limb movements of sleep); other sleep disorders.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Desmopressin and who got the comparison, which limits bias.

The Desmopressin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Desmopressin, so expectations could not easily colour the readings.

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

It started in 2013-04 with completion listed for 2014-06.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean number of nocturnal voids (time frame: 1 month and 3 months). Wake after sleep onset (time frame: 1 month and 3 months). Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale (time frame: 1 month and 3 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Desmopressin in 5 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.