Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2025-12-28 @ 5:26 PM
Study NCT ID:
NCT01779466
Status:
TERMINATED
Last Update Posted:
2015-04-27
First Post:
2013-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daytime Impact Sleep Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053158', 'term': 'Nocturia'}], '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'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Terminated due to lack of eligible patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-24', 'studyFirstSubmitDate': '2013-01-23', 'studyFirstSubmitQcDate': '2013-01-28', 'lastUpdatePostDateStruct': {'date': '2015-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean number of nocturnal voids', 'timeFrame': '1 month and 3 months', 'description': 'As measured by voiding diary'}, {'measure': 'Wake after sleep onset', 'timeFrame': '1 month and 3 months', 'description': 'i.e. time in minutes of epochs scored as wake from sleep onset latency until lights on. Measured by Polysomnography'}, {'measure': 'Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale', 'timeFrame': '1 month and 3 months', 'description': 'Daytime performance'}, {'measure': 'Mean time to first void', 'timeFrame': '1 month and 3 months', 'description': 'As measured by voiding diary'}, {'measure': 'Sleep efficiency', 'timeFrame': '1 month and 3 months', 'description': 'Sleep efficiency equals total sleep time divided by total recording time multiplied by 100. Measured by Polysomnography'}, {'measure': 'Sleep stage N1, N2, N3, (sleep stages in NREM (non-rapid eye movement) and REM (rapid eye movement) as a percentage of total sleep time', 'timeFrame': '1 month and 3 months', 'description': 'Measured by Polysomnography'}, {'measure': 'Number of awakenings due to nocturia', 'timeFrame': '1 month and 3 months', 'description': 'Measured by Polysomnography'}, {'measure': 'Latency to slow-wave sleep', 'timeFrame': '1 month and 3 months', 'description': 'Measured by Polysomnography'}, {'measure': 'Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset', 'timeFrame': '1 month and 3 months', 'description': 'Measured by Actigraphy'}, {'measure': 'Percent of sleep', 'timeFrame': '1 month and 3 months', 'description': 'Measured by Actigraphy'}, {'measure': 'Number of awakenings due to nocturia', 'timeFrame': '1 month and 3 months', 'description': 'Measured by Actigraphy'}, {'measure': 'Quality of life score measured by EQ-5D-5L', 'timeFrame': '1 month and 3 months', 'description': 'Daytime performance'}, {'measure': 'Safety - incidence of adverse events', 'timeFrame': '1 month and 3 months'}, {'measure': 'Safety - clinically significant changes in lab values', 'timeFrame': '1 week and 3 months'}, {'measure': 'Safety - clinically significant changes in vital signs', 'timeFrame': '1 week, 1 month and 3 months'}, {'measure': 'Safety - clinically significant changes in physical examination', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nocturia']}, 'descriptionModule': {'briefSummary': 'This trial will investigate the relationship of sleep, daytime performance and nocturia in patients treated with Desmopressin or placebo. Male and Female patients will be administered Desmopressin or Placebo every day for 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 2 night time voids per night\n* Habitual sleep of 6-9.5 hours per night\n* Experiencing symptoms of Nocturia greater than 6 months\n\nExclusion Criteria:\n\n* Greater than 10 night time voids\n* History of sleep apnoea and PLMS (Periodic Limb Movements of Sleep)\n* Other sleep disorders\n* Signs or symptoms of: Bladder outlet obstruction, severe lower urinary tract symptoms (LUTS), interstitial cystitis, moderate to severe overactive bladder (OAB), moderate to severe as judged by the investigator stress urinary incontinence\n* Urological malignancies\n* Neurogenic detrusor over activity (e.g. Parkinson, spinal cord damage, etc.)\n* Central or nephrogenic diabetes insipidus\n* Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40ml/Kg/24hrs)\n* Syndrome of inappropriate antidiuretic hormone (SIADH)\n* Cardiac failure evidence based on physical examination, cardiac medical history and electrocardiogram (ECG) output\n* Uncontrolled hypertension\n* Uncontrolled diabetes mellitus\n* Hyponatraemia with sodium \\<135 mmol/L\n* Renal insufficiency\n* Known or suspected clinically significant hepatic and/or biliary diseases'}, 'identificationModule': {'nctId': 'NCT01779466', 'acronym': 'DAISS', 'briefTitle': 'Daytime Impact Sleep Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Double-blind, Randomised, Parallel-group Trial Investigating Sleep Behaviour and Daytime Performance in Nocturia Patients Treated With Desmopressin Orally Disintegrating Tablets as Compared to Placebo', 'orgStudyIdInfo': {'id': '000088'}, 'secondaryIdInfos': [{'id': '2012-004388-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental A', 'interventionNames': ['Drug: Desmopressin']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental B', 'interventionNames': ['Drug: Desmopressin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo (not active)']}], 'interventions': [{'name': 'Desmopressin', 'type': 'DRUG', 'armGroupLabels': ['Experimental A', 'Experimental B']}, {'name': 'Placebo (not active)', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Surrey', 'country': 'United Kingdom', 'facility': 'Surrey Clinical Research Centre'}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}