Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients
Primary Purpose
Nocturia, Obstructive Sleep Apnoea
Status
Terminated
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Desmopressin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nocturia focused on measuring Nocturia, Obstructive sleep Apnoea, Desmopressin
Eligibility Criteria
Inclusion Criteria:
- Adult male or female patient (aged</=65 years old)
- Obstructive sleep apnoea diagnosed by sleep study
- Stable treatment on obstructive sleep apnoea and / or LUTS
- Nocturia on average more than once per night
- Having the ability to communicate and comply with the requirements of the study
Exclusion Criteria:
- Presence of urethral strictures and neurogenic bladder dysfunction
- Clinical evidence of bladder stones, bladder tumor or an active urinary tract infection
- History of prostate cancer or prostate specific antigen (PSA) level > 10ng/ml or suspicious of prostate cancer on digital rectal examination (DRE), unless a transrectal biopsy of prostate has been performed and the presence of prostate cancer has been excluded.
- Patient on intermittent self-catheterisation
- Recent start or change of treatment on obstructive sleep apnoea and / or nocturia
- Uncontrolled medical problems: e.g. Diabetes Mellitus or Diabetes insipidus
- Hyponatraemia
- Pregnancy
Sites / Locations
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A: Drug/ Placebo
B: Placebo/ Drug
Arm Description
Initial phase on Desmopressin and then cross over to placebo on the second phase
Initial phase on Placebo and then cross over to Desmopressin on the second phase
Outcomes
Primary Outcome Measures
Change in no. of nocturia
Secondary Outcome Measures
Side effects related to desmopressin
Change in quality of Life - NQOL
Change of quality of Sleep - PSQI
Change in lower urinary tract symptoms - OABSS
Full Information
NCT ID
NCT01530451
First Posted
February 2, 2012
Last Updated
February 2, 2015
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01530451
Brief Title
Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients
Official Title
Prospective, Randomized, Double-blind Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Insufficient funding
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate the efficacy of desmopressin on symptoms of nocturia in patients with Obstructive Sleep Apnoea (OSA). The improvement of sleep quality and the quality of life will be measured.
Detailed Description
Nocturia is one of the commonest urinary symptoms in elderly and in patients with obstructive sleep apnoea (OSA). According to the International Continence Society (ICS) definition, nocturia is defined as "the complaint that the individual has to wake at night one or more times to void" . It implies a continuum beginning from what might be considered normal, to a bothersome state. Bothersome nocturia is a common and age-dependent condition. A prevalence ranging from 48.6% to 77% were reported in the literature. Pathogenesis of nocturia is multi-factorial, and has closely related to OSA. OSA patients generate negative intrathoracic pressure during sleep, this leads to increased venous return and distension of the right atrium. This leads to an increase of hormone secretion, namely Atrial Natriuretic Peptide (ANP). ANP causes increased sodium and water excretion, and inhibits the secretion of antidiuretic hormone. All of the above factors results in an increased nocturnal urine production and nocturia.
Middle-aged men with OSA always present to urology clinic with lower urinary tract symptoms with predominant nocturia. Many a time they were treated as benign prostatic hyperplasia with multiple medications with suboptimal response. The underlying genuine pathology of OSA-related nocturia is overlooked.
Desmopressin is an analogue of antidiuretic hormone, it is the pharmacological therapy of choice for patients with nocturia where night-time polyuria is present.
In this study, the investigators would like to evaluate the efficacy of desmopressin on symptoms of nocturia in patients with Obstructive Sleep Apnoea (OSA). The improvement of sleep quality and the quality of life will be measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia, Obstructive Sleep Apnoea
Keywords
Nocturia, Obstructive sleep Apnoea, Desmopressin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A: Drug/ Placebo
Arm Type
Experimental
Arm Description
Initial phase on Desmopressin and then cross over to placebo on the second phase
Arm Title
B: Placebo/ Drug
Arm Type
Experimental
Arm Description
Initial phase on Placebo and then cross over to Desmopressin on the second phase
Intervention Type
Drug
Intervention Name(s)
Desmopressin
Other Intervention Name(s)
Minirin
Intervention Description
120mg OD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
one tab OD
Primary Outcome Measure Information:
Title
Change in no. of nocturia
Time Frame
Week 4 and Week 13
Secondary Outcome Measure Information:
Title
Side effects related to desmopressin
Time Frame
up to Week 13
Title
Change in quality of Life - NQOL
Time Frame
Week 4 and Week 13
Title
Change of quality of Sleep - PSQI
Time Frame
Week 4 and Week 13
Title
Change in lower urinary tract symptoms - OABSS
Time Frame
Week 4 and Week 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult male or female patient (aged</=65 years old)
Obstructive sleep apnoea diagnosed by sleep study
Stable treatment on obstructive sleep apnoea and / or LUTS
Nocturia on average more than once per night
Having the ability to communicate and comply with the requirements of the study
Exclusion Criteria:
Presence of urethral strictures and neurogenic bladder dysfunction
Clinical evidence of bladder stones, bladder tumor or an active urinary tract infection
History of prostate cancer or prostate specific antigen (PSA) level > 10ng/ml or suspicious of prostate cancer on digital rectal examination (DRE), unless a transrectal biopsy of prostate has been performed and the presence of prostate cancer has been excluded.
Patient on intermittent self-catheterisation
Recent start or change of treatment on obstructive sleep apnoea and / or nocturia
Uncontrolled medical problems: e.g. Diabetes Mellitus or Diabetes insipidus
Hyponatraemia
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eddie SY Chan
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
12. IPD Sharing Statement
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Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients
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