Daytime Impact Sleep Study - DAISS

• Research type

  Research Study

• Full title

  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

• IRAS ID

  122725

• Contact name

  Aldona Greenwood

• Sponsor organisation

  Ferring Pharmaceuticals A/S

• Eudract number

  2012-004388-34

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  Nocturia is a medical condition that results in individuals having to wake one or more times each night to void. The consequences of these disturbed sleep episodes include daytime drowsiness, a decrease in daytime performance, lower energy levels and a reduction in general well-being due to sleep deprivation. The incidence of nocturia increases with age and has been estimated at occurring in 60 ?? 90% of individuals aged between 70 and 80 years old. To date, there have been very few studies that have assessed the impact of nocturia on sleep. Desmopressin is an anti-diuretic drug very similar to the natural substance vasopressin, made by the body to control the amount of urine your kidneys produce. Desmopressin lowers urine production and has been shown to significantly reduce the number of nocturnal voids in male and female patients with nocturia and at the same time increase the first undisturbed sleep period which leads to an increase in quality of life. A new formulation of desmopressin (melt) has recently been developed which is a tablet placed under the tongue where it instantly dissolves without requiring water. The aim of this study is to assess the relationship between getting up at night to void, objective and subjective sleep quality, and daytime performance, and the impact of desmopressin on these parameters. 48 patients (35 ?? 65 years old) with nocturia (24 males, 24 females) will be studied in a placebo-controlled randomised trial where 24 patients (12M: 12F) will receive desmopressin (melt) and 24 patients (12M: 12F) will receive placebo (melt) daily for three months at one hour before bedtime. During this time the patients will complete four residential visits at the Surrey Clinical Research Centre where their sleep and daytime performance will be assessed. In addition, sleep at home will be recorded by actigraphy on five occasions.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  13/LO/0088

• Date of REC Opinion

  6 Mar 2013

• REC opinion

  Further Information Favourable Opinion