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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
5
Surrey Clinical Research Centre
Surrey, United Kingdom
Mean number of nocturnal voids
As measured by voiding diary
Time frame: 1 month and 3 months
Wake after sleep onset
i.e. time in minutes of epochs scored as wake from sleep onset latency until lights on. Measured by Polysomnography
Time frame: 1 month and 3 months
Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale
Daytime performance
Time frame: 1 month and 3 months
Mean time to first void
As measured by voiding diary
Time frame: 1 month and 3 months
Sleep efficiency
Sleep efficiency equals total sleep time divided by total recording time multiplied by 100. Measured by Polysomnography
Time frame: 1 month and 3 months
Sleep stage N1, N2, N3, (sleep stages in NREM (non-rapid eye movement) and REM (rapid eye movement) as a percentage of total sleep time
Measured by Polysomnography
Time frame: 1 month and 3 months
Number of awakenings due to nocturia
Measured by Polysomnography
Time frame: 1 month and 3 months
Latency to slow-wave sleep
Measured by Polysomnography
Time frame: 1 month and 3 months
Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset
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Measured by Actigraphy
Time frame: 1 month and 3 months
Percent of sleep
Measured by Actigraphy
Time frame: 1 month and 3 months
Number of awakenings due to nocturia
Measured by Actigraphy
Time frame: 1 month and 3 months
Quality of life score measured by EQ-5D-5L
Daytime performance
Time frame: 1 month and 3 months
Safety - incidence of adverse events
Time frame: 1 month and 3 months
Safety - clinically significant changes in lab values
Time frame: 1 week and 3 months
Safety - clinically significant changes in vital signs
Time frame: 1 week, 1 month and 3 months
Safety - clinically significant changes in physical examination
Time frame: 3 months