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Daytime Impact Sleep Study (DAISS)

Primary Purpose

Nocturia

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Desmopressin
Placebo (not active)
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturia

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Surrey Clinical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Experimental A

Experimental B

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Mean number of nocturnal voids
As measured by voiding diary
Wake after sleep onset
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
Daytime performance
Mean time to first void
As measured by voiding diary
Sleep efficiency
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
Measured by Polysomnography
Number of awakenings due to nocturia
Measured by Polysomnography
Latency to slow-wave sleep
Measured by Polysomnography
Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset
Measured by Actigraphy
Percent of sleep
Measured by Actigraphy
Number of awakenings due to nocturia
Measured by Actigraphy
Quality of life score measured by EQ-5D-5L
Daytime performance
Safety - incidence of adverse events
Safety - clinically significant changes in lab values
Safety - clinically significant changes in vital signs
Safety - clinically significant changes in physical examination

Secondary Outcome Measures

Full Information

First Posted
January 23, 2013
Last Updated
April 24, 2015
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01779466
Brief Title
Daytime Impact Sleep Study
Acronym
DAISS
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to lack of eligible patients
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental A
Arm Type
Experimental
Arm Title
Experimental B
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Desmopressin
Intervention Type
Drug
Intervention Name(s)
Placebo (not active)
Primary Outcome Measure Information:
Title
Mean number of nocturnal voids
Description
As measured by voiding diary
Time Frame
1 month and 3 months
Title
Wake after sleep onset
Description
i.e. time in minutes of epochs scored as wake from sleep onset latency until lights on. Measured by Polysomnography
Time Frame
1 month and 3 months
Title
Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale
Description
Daytime performance
Time Frame
1 month and 3 months
Title
Mean time to first void
Description
As measured by voiding diary
Time Frame
1 month and 3 months
Title
Sleep efficiency
Description
Sleep efficiency equals total sleep time divided by total recording time multiplied by 100. Measured by Polysomnography
Time Frame
1 month and 3 months
Title
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
Description
Measured by Polysomnography
Time Frame
1 month and 3 months
Title
Number of awakenings due to nocturia
Description
Measured by Polysomnography
Time Frame
1 month and 3 months
Title
Latency to slow-wave sleep
Description
Measured by Polysomnography
Time Frame
1 month and 3 months
Title
Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset
Description
Measured by Actigraphy
Time Frame
1 month and 3 months
Title
Percent of sleep
Description
Measured by Actigraphy
Time Frame
1 month and 3 months
Title
Number of awakenings due to nocturia
Description
Measured by Actigraphy
Time Frame
1 month and 3 months
Title
Quality of life score measured by EQ-5D-5L
Description
Daytime performance
Time Frame
1 month and 3 months
Title
Safety - incidence of adverse events
Time Frame
1 month and 3 months
Title
Safety - clinically significant changes in lab values
Time Frame
1 week and 3 months
Title
Safety - clinically significant changes in vital signs
Time Frame
1 week, 1 month and 3 months
Title
Safety - clinically significant changes in physical examination
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Surrey Clinical Research Centre
City
Surrey
Country
United Kingdom

12. IPD Sharing Statement

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Daytime Impact Sleep Study

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