Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT01530451
Status:
TERMINATED
Last Update Posted:
2015-02-04
First Post:
2012-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053158', 'term': 'Nocturia'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003894', 'term': 'Deamino Arginine Vasopressin'}], 'ancestors': [{'id': 'D001127', 'term': 'Arginine Vasopressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Insufficient funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-02', 'studyFirstSubmitDate': '2012-02-02', 'studyFirstSubmitQcDate': '2012-02-09', 'lastUpdatePostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in no. of nocturia', 'timeFrame': 'Week 4 and Week 13'}], 'secondaryOutcomes': [{'measure': 'Side effects related to desmopressin', 'timeFrame': 'up to Week 13'}, {'measure': 'Change in quality of Life - NQOL', 'timeFrame': 'Week 4 and Week 13'}, {'measure': 'Change of quality of Sleep - PSQI', 'timeFrame': 'Week 4 and Week 13'}, {'measure': 'Change in lower urinary tract symptoms - OABSS', 'timeFrame': 'Week 4 and Week 13'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nocturia', 'Obstructive sleep Apnoea', 'Desmopressin'], 'conditions': ['Nocturia', 'Obstructive Sleep Apnoea']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMiddle-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.\n\nDesmopressin is an analogue of antidiuretic hormone, it is the pharmacological therapy of choice for patients with nocturia where night-time polyuria is present.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or female patient (aged\\</=65 years old)\n* Obstructive sleep apnoea diagnosed by sleep study\n* Stable treatment on obstructive sleep apnoea and / or LUTS\n* Nocturia on average more than once per night\n* Having the ability to communicate and comply with the requirements of the study\n\nExclusion Criteria:\n\n* Presence of urethral strictures and neurogenic bladder dysfunction\n* Clinical evidence of bladder stones, bladder tumor or an active urinary tract infection\n* 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.\n* Patient on intermittent self-catheterisation\n* Recent start or change of treatment on obstructive sleep apnoea and / or nocturia\n* Uncontrolled medical problems: e.g. Diabetes Mellitus or Diabetes insipidus\n* Hyponatraemia\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01530451', 'briefTitle': 'Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Prospective, Randomized, Double-blind Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients', 'orgStudyIdInfo': {'id': 'NOCOSA-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: Drug/ Placebo', 'description': 'Initial phase on Desmopressin and then cross over to placebo on the second phase', 'interventionNames': ['Drug: Desmopressin', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'B: Placebo/ Drug', 'description': 'Initial phase on Placebo and then cross over to Desmopressin on the second phase', 'interventionNames': ['Drug: Desmopressin', 'Drug: Placebo']}], 'interventions': [{'name': 'Desmopressin', 'type': 'DRUG', 'otherNames': ['Minirin'], 'description': '120mg OD', 'armGroupLabels': ['A: Drug/ Placebo', 'B: Placebo/ Drug']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'one tab OD', 'armGroupLabels': ['A: Drug/ Placebo', 'B: Placebo/ Drug']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'overallOfficials': [{'name': 'Eddie SY Chan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Honorary Associate Professor', 'investigatorFullName': 'Eddie SY Chan, MD', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}