Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients
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|ClinicalTrials.gov Identifier: NCT01530451|
Recruitment Status : Terminated (Insufficient funding)
First Posted : February 10, 2012
Last Update Posted : February 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Nocturia Obstructive Sleep Apnoea||Drug: Desmopressin Drug: Placebo||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
Experimental: A: Drug/ Placebo
Initial phase on Desmopressin and then cross over to placebo on the second phase
Other Name: Minirin
one tab OD
Experimental: B: Placebo/ Drug
Initial phase on Placebo and then cross over to Desmopressin on the second phase
Other Name: Minirin
one tab OD
- Change in no. of nocturia [ Time Frame: Week 4 and Week 13 ]
- Side effects related to desmopressin [ Time Frame: up to Week 13 ]
- Change in quality of Life - NQOL [ Time Frame: Week 4 and Week 13 ]
- Change of quality of Sleep - PSQI [ Time Frame: Week 4 and Week 13 ]
- Change in lower urinary tract symptoms - OABSS [ Time Frame: Week 4 and Week 13 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530451
|Prince of Wales Hospital|
|Shatin, Hong Kong|
|Principal Investigator:||Eddie SY Chan||Chinese University of Hong Kong|