Daytime Impact Sleep Study
- Registration Number
- NCT01779466
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo (not active) - Experimental B Desmopressin - Experimental A Desmopressin -
- Primary Outcome Measures
Name Time Method Wake after sleep onset 1 month and 3 months i.e. time in minutes of epochs scored as wake from sleep onset latency until lights on. Measured by Polysomnography
Mean number of nocturnal voids 1 month and 3 months As measured by voiding diary
Sleep efficiency 1 month and 3 months Sleep efficiency equals total sleep time divided by total recording time multiplied by 100. Measured by Polysomnography
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 1 month and 3 months Measured by Polysomnography
Number of awakenings due to nocturia 1 month and 3 months Measured by Actigraphy
Latency to slow-wave sleep 1 month and 3 months Measured by Polysomnography
Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale 1 month and 3 months Daytime performance
Mean time to first void 1 month and 3 months As measured by voiding diary
Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset 1 month and 3 months Measured by Actigraphy
Percent of sleep 1 month and 3 months Measured by Actigraphy
Quality of life score measured by EQ-5D-5L 1 month and 3 months Daytime performance
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Surrey Clinical Research Centre
🇬🇧Surrey, United Kingdom