Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients

Phase 3TerminatedNCT01530451

Chinese University of Hong Kong9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Nocturia Obstructive Sleep Apnoea

Interventions

DesmopressinDRUG

120mg OD

PlaceboDRUG

one tab OD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Prince of Wales Hospital

Shatin, Hong Kong

Outcomes

Primary Outcomes

Change in no. of nocturia

Time frame: Week 4 and Week 13

Secondary Outcomes

Side effects related to desmopressin

Time frame: up to Week 13

Change in quality of Life - NQOL

Time frame: Week 4 and Week 13

Change of quality of Sleep - PSQI

Time frame: Week 4 and Week 13

Change in lower urinary tract symptoms - OABSS

Time frame: Week 4 and Week 13

Data from ClinicalTrials.gov

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