Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective, Randomized, Double-blind Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients

Conditions
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Nocturia, Obstructive Sleep Apnoea

Intervention / Treatment
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* Drug: Desmopressin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Drug/ Placebo<br>Initial phase on Desmopressin and then cross over to placebo on the second phase | Drug: Desmopressin<br>* 120mg OD<br>* Other names: Minirin;Drug: Placebo<br>* one tab OD<br>|
| Experimental: B: Placebo/ Drug<br>Initial phase on Placebo and then cross over to Desmopressin on the second phase | Drug: Desmopressin<br>* 120mg OD<br>* Other names: Minirin;Drug: Placebo<br>* one tab OD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in no. of nocturia |  | Week 4 and Week 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects related to desmopressin |  | up to Week 13 | 
| Change in quality of Life - NQOL |  | Week 4 and Week 13 | 
| Change of quality of Sleep - PSQI |  | Week 4 and Week 13 | 
| Change in lower urinary tract symptoms - OABSS |  | Week 4 and Week 13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nocturia, Obstructive sleep Apnoea, Desmopressin