Daytime Impact Sleep Study (DAISS)

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.

Study Overview

• Status: Terminated
• Conditions: Nocturia
• Intervention / Treatment: Drug: Desmopressin; Drug: Placebo (not active)

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey, United Kingdom
    • Surrey Clinical Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo (not active)
Experimental: Experimental B	Drug: Desmopressin
Experimental: Experimental A	Drug: Desmopressin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: January 28, 2013
• First Posted (Estimate): January 30, 2013

Study Record Updates

• Last Update Posted (Estimate): April 27, 2015
• Last Update Submitted That Met QC Criteria: April 24, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lower Urinary Tract Symptoms; Urological Manifestations; Nocturia; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Antidiuretic Agents; Deamino Arginine Vasopressin
• Other Study ID Numbers: 000088 (FSRG #1 IRB); 2012-004388-34 (EudraCT Number)