Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-01-03 @ 3:26 AM
Study NCT ID:
NCT00245661
Status:
COMPLETED
Last Update Posted:
2007-11-02
First Post:
2005-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Temazepam in Patients With Chronic Pulmonary Obstructive Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013693', 'term': 'Temazepam'}], 'ancestors': [{'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-31', 'studyFirstSubmitDate': '2005-10-27', 'studyFirstSubmitQcDate': '2005-10-27', 'lastUpdatePostDateStruct': {'date': '2007-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'transcutaneous PCO2'}, {'measure': 'transcutaneous PO2'}, {'measure': 'Oxygen saturation'}], 'secondaryOutcomes': [{'measure': 'Respiratory Disturbance Index'}, {'measure': 'Desaturation Index'}, {'measure': 'MSLT'}, {'measure': 'arterial PO2'}, {'measure': 'arterial PCO2'}, {'measure': 'Hypercapnic Ventilatory Response'}, {'measure': 'total sleeping time'}, {'measure': 'sleep latency'}, {'measure': 'percentage REM- and nREM-sleep of total sleep time'}, {'measure': 'number of arousals'}, {'measure': 'number of apneas during sleep'}, {'measure': 'number of hypopneas during sleep'}, {'measure': 'Epworth Sleeping Score'}, {'measure': 'Dyspnea Visual Analog Score'}]}, 'conditionsModule': {'keywords': ['COPD', 'respiratory', 'sleep quality', 'temazepam', 'dyspnea'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '19910177', 'type': 'DERIVED', 'citation': 'Stege G, Heijdra YF, van den Elshout FJ, van de Ven MJ, de Bruijn PJ, van Sorge AA, Dekhuijzen PN, Vos PJ. Temazepam 10mg does not affect breathing and gas exchange in patients with severe normocapnic COPD. Respir Med. 2010 Apr;104(4):518-24. doi: 10.1016/j.rmed.2009.10.022. Epub 2009 Nov 12.'}], 'seeAlsoLinks': [{'url': 'http://www.alysis.nl/site/index_html', 'label': "sponsor's web site"}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of temazepam during sleep and in daytime on dyspnea, gas exchange and sleep quality in patients with chronic obstructive pulmonary disease.\n\nThe study hypothesis is that temazepam does not produce any adverse respiratory effects during sleep in patients with COPD. In contrast, it may result in an beneficiary effect because it positively affects the sleep quality and sleep structure which may result in more alertness and less daytime sleepiness and less dyspnea during the day.', 'detailedDescription': "Rationale: More than 50% of patients with chronic obstructive pulmonary disease (COPD) have sleep complaints characterised by longer latency to falling asleep, more frequent arousals and awakenings, generalised insomnia and/or excessive daytime sleepiness. Sleep disturbance seems to be more severe with advancing disease and substantially reduces patients' quality of life. The sleep complaints are due to dyspnea, chronic cough, sputum production, hypoxaemia and hypercapnia during the night. One of the available therapies for these patients is the prescription of hypnotics (like benzodiazepines). However, it is thought that in patients with COPD sleep medication may produce adverse respiratory effects due to suppression of the cerebral respiratory drive. In our practice, we never encounter any adverse respiratory effect of an hypnotic in patients with COPD. There have been several trials in COPD patients studying these potentially adverse effects. The results of these studies are inconsistent, relative older hypnotics are used and there are several methodological limitations. Furthermore, in none of these studies transcutaneous PCO2 or PO2 was monitored. Temazepam is nowadays the sedative of first choice in the medical treatment of sleep complaints.\n\nAim: primary: studying the effects of temazepam on the respiratory function during daytime and at night in patients with severe COPD. Secondary: studying the effects of temazepam on the sleep quality and sleep structure and on the objective and subjective sleepiness during daytime and at night in patients with COPD.\n\nStudy design: double blind, placebo-controlled, cross-over randomised clinical trial.\n\nTreatment: 10 mg temazepam or placebo during seven consecutive nights.\n\nEndpoints: Primary: difference in PtcCO2, PtcO2 and oxygen saturation during sleep after 1 week temazepam compared to placebo. Secondary: Respiratory Disturbance Index, Desaturation Index and Hypercapnic Ventilatory Response, percentage REM/nREM-sleep and total effective sleep time, Multiple Sleep Latency Test and the Epworth Sleeping Score."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of COPD, GOLD 3 or 4\n* having subjective sleeping problems\n\n * longer latency to falling asleep\n * frequent arousals\n * excessive daytime sleepiness\n* clinical stable health for minimally 6 weeks\n\nExclusion Criteria:\n\n* usage of some sort of medication that influences sleep in any kind of way (like benzodiazepines, barbiturates, opiates, amfetamines) which can not be discontinued during the study period\n* alcohol abuse\n* hospitalisation 6 weeks or shorter before enrollment in the study\n* hyperreactivity / allergy to benzodiazepines\n* history of benzodiazepine-dependence\n* myasthenia gravis\n* obstructive sleep apnea syndrome (OSAS)\n* severe liver failure\n* age under 18 years\n* participation in another study less than 6 weeks before enrollment\n* COPD exacerbation less than 6 weeks before enrollment\n* usage of oxygen supplementation at home'}, 'identificationModule': {'nctId': 'NCT00245661', 'briefTitle': 'Effects of Temazepam in Patients With Chronic Pulmonary Obstructive Disease', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'Effects of Temazepam on Dyspnea, Gas Exchange and Sleep Quality in Chronic Obstructive Pulmonary Disease.', 'orgStudyIdInfo': {'id': 'LTC-346/050905/Stege'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Temazepam', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6800 TA', 'city': 'Arnhem', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}], 'overallOfficials': [{'name': 'Gerben Stege, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rijnstate Hospital'}, {'name': 'Peter J de Bruijn, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rijnstate Hospital'}, {'name': 'Richard PN Dekhuijzen, Prof. PhD MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UMC St. Radboud'}, {'name': 'Frank JJ van den Elshout, PhD MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rijnstate Hospital'}, {'name': 'Yvonne F Heijdra, PhD MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UMC St. Radboud'}, {'name': 'Marjo JT van de Ven, PhD MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rijnstate Hospital'}, {'name': 'Petra JE Vos, PhD MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rijnstate Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}}}}