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Daytime Impact Sleep Study (DAISS)

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ClinicalTrials.gov Identifier: NCT01779466
Recruitment Status : Terminated (Terminated due to lack of eligible patients)
First Posted : January 30, 2013
Last Update Posted : April 27, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Nocturia Drug: Desmopressin Drug: Placebo (not active) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental A Drug: Desmopressin
Experimental: Experimental B Drug: Desmopressin
Placebo Comparator: Placebo Drug: Placebo (not active)



Primary Outcome Measures :
  1. Mean number of nocturnal voids [ Time Frame: 1 month and 3 months ]
    As measured by voiding diary

  2. Wake after sleep onset [ Time Frame: 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

  3. Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale [ Time Frame: 1 month and 3 months ]
    Daytime performance

  4. Mean time to first void [ Time Frame: 1 month and 3 months ]
    As measured by voiding diary

  5. Sleep efficiency [ Time Frame: 1 month and 3 months ]
    Sleep efficiency equals total sleep time divided by total recording time multiplied by 100. Measured by Polysomnography

  6. 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 ]
    Measured by Polysomnography

  7. Number of awakenings due to nocturia [ Time Frame: 1 month and 3 months ]
    Measured by Polysomnography

  8. Latency to slow-wave sleep [ Time Frame: 1 month and 3 months ]
    Measured by Polysomnography

  9. Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset [ Time Frame: 1 month and 3 months ]
    Measured by Actigraphy

  10. Percent of sleep [ Time Frame: 1 month and 3 months ]
    Measured by Actigraphy

  11. Number of awakenings due to nocturia [ Time Frame: 1 month and 3 months ]
    Measured by Actigraphy

  12. Quality of life score measured by EQ-5D-5L [ Time Frame: 1 month and 3 months ]
    Daytime performance

  13. Safety - incidence of adverse events [ Time Frame: 1 month and 3 months ]
  14. Safety - clinically significant changes in lab values [ Time Frame: 1 week and 3 months ]
  15. Safety - clinically significant changes in vital signs [ Time Frame: 1 week, 1 month and 3 months ]
  16. Safety - clinically significant changes in physical examination [ Time Frame: 3 months ]


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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779466


Locations
United Kingdom
Surrey Clinical Research Centre
Surrey, United Kingdom
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01779466     History of Changes
Other Study ID Numbers: 000088
2012-004388-34 ( EudraCT Number )
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: April 27, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs