Daytime Impact Sleep Study

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

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.

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