Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-25 @ 2:15 PM
Study NCT ID:
NCT01228695
Status:
COMPLETED
Last Update Posted:
2010-10-26
First Post:
2010-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study of the Impact of Systemic Corticosteroid Use on Measures of Sleep Disordered Breathing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-25', 'studyFirstSubmitDate': '2010-10-21', 'studyFirstSubmitQcDate': '2010-10-25', 'lastUpdatePostDateStruct': {'date': '2010-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'apnea-hypopnea index', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'sleep study variables', 'timeFrame': '3 months', 'description': 'apnea-hypopnea interval desaturation at the end of apnea interval snoring intensity'}]}, 'conditionsModule': {'keywords': ['steroids', 'patients treated with systemic steroids'], 'conditions': ['Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '14736085', 'type': 'BACKGROUND', 'citation': 'Yigla M, Tov N, Solomonov A, Rubin AH, Harlev D. Difficult-to-control asthma and obstructive sleep apnea. J Asthma. 2003 Dec;40(8):865-71. doi: 10.1081/jas-120023577.'}]}, 'descriptionModule': {'briefSummary': 'Weight gain is both a significant risk factor for obstructive sleep apnea and a side-effect of long-term systemic steroids therapy.\n\nThis study aimed to investigate the impact of long-term systemic steroid treatment on sleep apnea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients scheduled for long-term treatment with oral prednisone (\\> 10 mg/d for 3 months or more)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For inclusion, a scheduled therapy with a minimum daily dose of 10 mg prednisone (or equivalent) for at least 3 months was required\n\nExclusion Criteria:\n\n* Patients younger than 18 years and those with known sleep apnea or other forms of sleep-disordered breathing were excluded'}, 'identificationModule': {'nctId': 'NCT01228695', 'briefTitle': 'Prospective Study of the Impact of Systemic Corticosteroid Use on Measures of Sleep Disordered Breathing', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'orgStudyIdInfo': {'id': 'IRB2421CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'steroid treatment', 'interventionNames': ['Other: sleep study']}], 'interventions': [{'name': 'sleep study', 'type': 'OTHER', 'otherNames': ['no other names'], 'description': 'The polysomnography (PSG) (Alice 3 System; Healthdyne, Atlanta, GA) consisted of continuous polygraphic recording from surface leads for electroencephalography, electrooculography, electromyography, electrocardiography, thermistors for nasal and oral airflow, thoracic and abdominal impedance belts for respiratory effort, pulse oximeter for oxyhemoglobin level, tracheal microphone for snoring, and sensors for leg and sleep position', 'armGroupLabels': ['steroid treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam health care campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Israeli association for lung disease', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Israeli association for lung disease'}}}}