Daytime Impact Sleep Study (DAISS)

This study has been terminated.
(Terminated due to lack of eligible patients)
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01779466
First received: January 23, 2013
Last updated: March 6, 2014
Last verified: March 2014

January 23, 2013
March 6, 2014
April 2013
June 2014   (final data collection date for primary outcome measure)
  • Mean number of nocturnal voids [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: No ]
    As measured by voiding diary
  • Wake after sleep onset [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: No ]
    i.e. time in minutes of epochs scored as wake from sleep onset latency until lights on. Measured by Polysomnography
  • Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: No ]
    Daytime performance
  • Mean time to first void [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: No ]
    As measured by voiding diary
  • Sleep efficiency [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: No ]
    Measured by Polysomnography
  • Number of awakenings due to nocturia [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: No ]
    Measured by Polysomnography
  • Latency to slow-wave sleep [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: No ]
    Measured by Polysomnography
  • Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: No ]
    Measured by Actigraphy
  • Percent of sleep [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: No ]
    Measured by Actigraphy
  • Number of awakenings due to nocturia [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: No ]
    Measured by Actigraphy
  • Quality of life score measured by EQ-5D-5L [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: No ]
    Daytime performance
  • Safety - incidence of adverse events [ Time Frame: 1 month and 3 months ] [ Designated as safety issue: Yes ]
  • Safety - clinically significant changes in lab values [ Time Frame: 1 week and 3 months ] [ Designated as safety issue: Yes ]
  • Safety - clinically significant changes in vital signs [ Time Frame: 1 week, 1 month and 3 months ] [ Designated as safety issue: Yes ]
  • Safety - clinically significant changes in physical examination [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01779466 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Nocturia
  • Drug: Desmopressin
  • Drug: Placebo (not active)
  • Experimental: Experimental A
    Intervention: Drug: Desmopressin
  • Experimental: Experimental B
    Intervention: Drug: Desmopressin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo (not active)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
25 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01779466
000088, 2012-004388-34
No
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP