Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients

Phase 3

Terminated

• Conditions: Nocturia; Obstructive Sleep Apnoea
• Interventions: Drug: Desmopressin; Drug: Placebo

• Registration Number: NCT01530451
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-10
• Study Start: 2012-03
• Status Verified: 2015-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A: Drug/ Placebo	Placebo	Initial phase on Desmopressin and then cross over to placebo on the second phase
B: Placebo/ Drug	Placebo	Initial phase on Placebo and then cross over to Desmopressin on the second phase
B: Placebo/ Drug	Desmopressin	Initial phase on Placebo and then cross over to Desmopressin on the second phase
A: Drug/ Placebo	Desmopressin	Initial phase on Desmopressin and then cross over to placebo on the second phase

Primary Outcome Measures

Name	Time	Method
Change in no. of nocturia	Week 4 and Week 13

Secondary Outcome Measures

Name	Time	Method
Change of quality of Sleep - PSQI	Week 4 and Week 13
Change in lower urinary tract symptoms - OABSS	Week 4 and Week 13
Side effects related to desmopressin	up to Week 13
Change in quality of Life - NQOL	Week 4 and Week 13

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong