Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients

• ClinicalTrials.gov Identifier: NCT01530451
• Recruitment Status: Terminated
• First Posted: February 10, 2012
• Last Update Posted: February 4, 2015
• Sponsor: Chinese University of Hong Kong
• Information provided by (Responsible Party): Eddie SY Chan, MD, Chinese University of Hong Kong

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Nocturia; Obstructive Sleep Apnoea	Drug: Desmopressin; Drug: Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prospective, Randomized, Double-blind Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients
• Study Start Date: March 2012
• Actual Primary Completion Date: February 2015
• Actual Study Completion Date: February 2015

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :

1. Change in no. of nocturia [ Time Frame: Week 4 and Week 13 ]

Secondary Outcome Measures :

1. Side effects related to desmopressin [ Time Frame: up to Week 13 ]
2. Change in quality of Life - NQOL [ Time Frame: Week 4 and Week 13 ]
3. Change of quality of Sleep - PSQI [ Time Frame: Week 4 and Week 13 ]
4. Change in lower urinary tract symptoms - OABSS [ Time Frame: Week 4 and Week 13 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Hong Kong

Prince of Wales Hospital

Shatin, Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

• Principal Investigator: Eddie SY Chan; Chinese University of Hong Kong

More Information

• Responsible Party: Eddie SY Chan, MD, Honorary Associate Professor, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT01530451
• Other Study ID Numbers: NOCOSA-001
• First Posted: February 10, 2012
• Last Update Posted: February 4, 2015
• Last Verified: February 2015

Keywords provided by Eddie SY Chan, MD, Chinese University of Hong Kong:

Nocturia; Obstructive sleep Apnoea; Desmopressin

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Nocturia; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Deamino Arginine Vasopressin; Hemostatics; Coagulants; Antidiuretic Agents; Natriuretic Agents; Physiological Effects of Drugs