Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients

Nocturia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01530451
• Other study ID #: NOCOSA-001
• Status: Terminated
• Phase: Phase 3
• First received: February 2, 2012
• Last updated: February 2, 2015
• Start date: March 2012
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Nocturia
• Obstructive Sleep Apnoea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Desmopressin
120mg OD
• Placebo
one tab OD

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in no. of nocturia		Week 4 and Week 13	No
Secondary	Side effects related to desmopressin		up to Week 13	Yes
Secondary	Change in quality of Life - NQOL		Week 4 and Week 13	No
Secondary	Change of quality of Sleep - PSQI		Week 4 and Week 13	No
Secondary	Change in lower urinary tract symptoms - OABSS		Week 4 and Week 13	No