Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Eddie SY Chan, MD, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01530451
First received: February 2, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Nocturia
Obstructive Sleep Apnoea
Drug: Desmopressin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Double-blind Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Change in no. of nocturia [ Time Frame: Week 4 and Week 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects related to desmopressin [ Time Frame: up to Week 13 ] [ Designated as safety issue: Yes ]
  • Change in quality of Life - NQOL [ Time Frame: Week 4 and Week 13 ] [ Designated as safety issue: No ]
  • Change of quality of Sleep - PSQI [ Time Frame: Week 4 and Week 13 ] [ Designated as safety issue: No ]
  • Change in lower urinary tract symptoms - OABSS [ Time Frame: Week 4 and Week 13 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Drug/ Placebo
Initial phase on Desmopressin and then cross over to placebo on the second phase
Drug: Desmopressin
120mg OD
Other Name: 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 Name: Minirin
Drug: Placebo
one tab OD

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530451

Contacts
Contact: Eddie SY Chan (852) 2632 2625 eddie@surgery.cuhk.edu.hk

Locations
Hong Kong
Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Contact: Eddie SY Chan    (852) 2632 2625    eddie@surgery.cuhk.edu.hk   
Principal Investigator: Eddie SY Chan, MD         
Sub-Investigator: Wai Yeung Wong         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Eddie SY Chan Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Eddie SY Chan, MD, Honorary Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01530451     History of Changes
Other Study ID Numbers: NOCOSA-001
Study First Received: February 2, 2012
Last Updated: July 21, 2014
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Nocturia
Obstructive sleep Apnoea
Desmopressin

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Nocturia
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Lower Urinary Tract Symptoms
Urological Manifestations
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 16, 2014