Clinical trial NCT01779466: Daytime Impact Sleep Study
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nocturia
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-01-30
Enrollment: 5
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean number of nocturnal voids
timeFrame: 1 month and 3 months
measure: Wake after sleep onset
timeFrame: 1 month and 3 months
measure: Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale
timeFrame: 1 month and 3 months
measure: Mean time to first void
timeFrame: 1 month and 3 months
measure: Sleep efficiency
timeFrame: 1 month and 3 months
measure: 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
timeFrame: 1 month and 3 months
measure: Number of awakenings due to nocturia
timeFrame: 1 month and 3 months
measure: Latency to slow-wave sleep
timeFrame: 1 month and 3 months
measure: Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset
timeFrame: 1 month and 3 months
measure: Percent of sleep
timeFrame: 1 month and 3 months
measure: Number of awakenings due to nocturia
timeFrame: 1 month and 3 months
measure: Quality of life score measured by EQ-5D-5L
timeFrame: 1 month and 3 months
measure: Safety - incidence of adverse events
timeFrame: 1 month and 3 months
measure: Safety - clinically significant changes in lab values
timeFrame: 1 week and 3 months
measure: Safety - clinically significant changes in vital signs
timeFrame: 1 week, 1 month and 3 months
measure: Safety - clinically significant changes in physical examination
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Surrey
country: United Kingdom
facility: Surrey Clinical Research Centre
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: