Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients

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

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.

Study Overview

• Status: Terminated
• Conditions: Nocturia; Obstructive Sleep Apnoea
• Intervention / Treatment: Drug: Desmopressin; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 3

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A: Drug/ Placebo; Initial phase on Desmopressin and then cross over to placebo on the second phase	Drug: Desmopressin; 120mg OD; Other Names: Minirin; Drug: Placebo; one tab OD
EXPERIMENTAL: B: Placebo/ Drug; Initial phase on Placebo and then cross over to Desmopressin on the second phase	Drug: Desmopressin; 120mg OD; Other Names: Minirin; Drug: Placebo; one tab OD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Eddie SY Chan, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2015

Study Registration Dates

• First Submitted: February 2, 2012
• First Submitted That Met QC Criteria: February 9, 2012
• First Posted (ESTIMATE): February 10, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 4, 2015
• Last Update Submitted That Met QC Criteria: February 2, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Desmopressin; Nocturia; Obstructive sleep Apnoea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Nocturia; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Antidiuretic Agents; Deamino Arginine Vasopressin
• Other Study ID Numbers: NOCOSA-001