Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT03725956
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2018-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polysomnographic Findings in Nasal Polyposis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D009298', 'term': 'Nasal Polyps'}], 'ancestors': [{'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'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2018-10-18', 'studyFirstSubmitQcDate': '2018-10-29', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Slow-wave sleep duration', 'timeFrame': '1 month before surgery and 3 months postoperatively', 'description': 'Slow-wave sleep duration is measured one month before surgery and 3 months after surgery'}], 'secondaryOutcomes': [{'measure': 'change in total sleep duration', 'timeFrame': 'At 1 month before surgery and at 3 months postoperatively'}, {'measure': 'Change in the number of brief wakefulness', 'timeFrame': 'At 1 month before surgery and at 3 months postoperatively'}, {'measure': 'change in Apnea-hypopnea index', 'timeFrame': 'At 1 month before surgery and at 3 months postoperatively', 'description': 'This index measures the number of apnea and hypopnea during the total sleep duration.'}, {'measure': 'Change in time with oxygen desaturation below 90%', 'timeFrame': 'At 1 month before surgery and at 3 months postoperatively'}, {'measure': 'change in Epworth sleepiness scale scores', 'timeFrame': 'At 1 month before surgery and at 3 months postoperatively', 'description': 'The Epworth sleepiness scale score is a questionnaire based of 8 questions assessing daytime sleepiness. Each question is graded from 0 to 3. A total score ranging from 0 to 24 is established:\n\n1 to 6 points: Normal sleep 7 to 8 points: Average sleepiness 9 to 24 points: Abnormal (possibly pathologic) sleepiness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasal polyposis', 'sleep', 'sinus surgery', 'polysomnography', 'quality of life'], 'conditions': ['Chronic Rhinosinusitis With Nasal Polyps', 'Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Nasal polyposis (NP) is a chronic inflammatory disease of the nasal and sinus mucosa leading to protrusion of edematous polyps in the nasal cavity. Prevalence of NP among the chronic rhinosinusitis patients is 25-30 %. NP leads to significant limitations in physical, emotional and social aspects of life of the affected patients. Sleep disorder is frequently reported by those patients with impaired nasal breathing. Till now few studies have objectively assessed the impact of NP on sleep quality. the objectives are to figure out sleep disturbances in NP and to analyze the outcomes of sinus surgery on sleep recovering.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent endoscopic sinus surgery for recalcitrant nasal polyposis (failure of a 4-month corticosteroid medical treatment) Social insured patient\n* Patient willing to comply with all procedures of the study and its duration\n* Patient giving consent\n\nExclusion Criteria:\n\n* Patients with previous nasal surgery for nasal polyposis\n* Patients with previous continuous positive airway pressure therapy for obstructive sleep apnea\n* Non-coverage by the social security scheme\n* Patient unable to receive informed information\n* Refusal to sign the consent\n* Person deprived of the liberty\n* Person benefiting from a system of legal protection (guardianship…)'}, 'identificationModule': {'nctId': 'NCT03725956', 'acronym': 'POLYSOMNO', 'briefTitle': 'Polysomnographic Findings in Nasal Polyposis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Effects of Endoscopic Sinus Surgery on Sleep Disorder in Patients With Chronic Rhinosinusitis With Polyps', 'orgStudyIdInfo': {'id': '2018_19'}, 'secondaryIdInfos': [{'id': '2018-A01650-55', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'endoscopic sinus surgery', 'description': 'Single group of patients with nasal polyposis eligible for endoscopic sinus surgery', 'interventionNames': ['Procedure: Endoscopic sinus surgery']}], 'interventions': [{'name': 'Endoscopic sinus surgery', 'type': 'PROCEDURE', 'description': 'Surgical procedure under general anaesthesia:\n\nConsists of the removal of bone boundaries between sinus cavities (ethmoidectomy) with nasal polyps resection in order to retrieve nasal patency and sinus drainage Polysomnographic assessment as routinely applied in clinical practice', 'armGroupLabels': ['endoscopic sinus surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Geoffrey Mortuaire, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Claude Huriez, CHU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Geoffrey Mortuaire, MD', 'role': 'CONTACT', 'email': 'geoffrey.mortuaire@chru-lille.fr', 'phone': '03 20 44 56 72', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Geoffrey Mortuaire, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}