Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients

NCT ID: NCT01530451

Last Updated: 2015-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-02-28

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.

Conditions

Nocturia; Obstructive Sleep Apnoea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A: Drug/ Placebo

Initial phase on Desmopressin and then cross over to placebo on the second phase

Group Type: EXPERIMENTAL

Desmopressin

Intervention Type: DRUG

120mg OD

Placebo

Intervention Type: DRUG

one tab OD

B: Placebo/ Drug

Initial phase on Placebo and then cross over to Desmopressin on the second phase

Group Type: EXPERIMENTAL

Desmopressin

Intervention Type: DRUG

120mg OD

Placebo

Intervention Type: DRUG

one tab OD

Interventions

Desmopressin

120mg OD

Intervention Type: DRUG

Placebo

one tab OD

Intervention Type: DRUG

Other Intervention Names

Minirin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Eddie SY Chan, MD

Honorary Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eddie SY Chan

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Shatin, , Hong Kong

Countries

Hong Kong

Other Identifiers

NOCOSA-001

Identifier Type: -

Identifier Source: org_study_id