Daytime Impact Sleep Study

Study Overview
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Brief Summary
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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.

Official Title
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A Double-blind, Randomised, Parallel-group Trial Investigating Sleep Behaviour and Daytime Performance in Nocturia Patients Treated With Desmopressin Orally Disintegrating Tablets as Compared to Placebo

Conditions
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Nocturia

Intervention / Treatment
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* Drug: Desmopressin
* Drug: Placebo (not active)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Greater than 10 night time voids History of sleep apnoea and PLMS (Periodic Limb Movements of Sleep) Other sleep disorders Signs or symptoms of: Bladder outlet obstruction, severe lower urinary tract symptoms (LUTS), interstitial cystitis, moderate to severe overactive bladder (OAB), moderate to severe as judged by the investigator stress urinary incontinence Urological malignancies Neurogenic detrusor over activity (e.g. Parkinson, spinal cord damage, etc.) Central or nephrogenic diabetes insipidus Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40ml/Kg/24hrs) Syndrome of inappropriate antidiuretic hormone (SIADH) Cardiac failure evidence based on physical examination, cardiac medical history and electrocardiogram (ECG) output Uncontrolled hypertension Uncontrolled diabetes mellitus Hyponatraemia with sodium <135 mmol/L Renal insufficiency Known or suspected clinically significant hepatic and/or biliary diseases

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental A<br> | Drug: Desmopressin<br> <br> |
| Experimental: Experimental B<br> | Drug: Desmopressin<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo (not active)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of nocturnal voids | As measured by voiding diary | 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 | 1 month and 3 months | 
| Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale | Daytime performance | 1 month and 3 months | 
| Mean time to first void | As measured by voiding diary | 1 month and 3 months | 
| Sleep efficiency | Sleep efficiency equals total sleep time divided by total recording time multiplied by 100. Measured by Polysomnography | 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 | 1 month and 3 months | 
| Number of awakenings due to nocturia | Measured by Polysomnography | 1 month and 3 months | 
| Latency to slow-wave sleep | Measured by Polysomnography | 1 month and 3 months | 
| Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset | Measured by Actigraphy | 1 month and 3 months | 
| Percent of sleep | Measured by Actigraphy | 1 month and 3 months | 
| Number of awakenings due to nocturia | Measured by Actigraphy | 1 month and 3 months | 
| Quality of life score measured by EQ-5D-5L | Daytime performance | 1 month and 3 months | 
| Safety - incidence of adverse events |  | 1 month and 3 months | 
| Safety - clinically significant changes in lab values |  | 1 week and 3 months | 
| Safety - clinically significant changes in vital signs |  | 1 week, 1 month and 3 months | 
| Safety - clinically significant changes in physical examination |  | 3 months |