Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-02-24 @ 5:51 AM
Study NCT ID:
NCT05116657
Status:
UNKNOWN
Last Update Posted:
2021-11-11
First Post:
2021-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obstructive Sleep Apnoea Post Covid 19: Role of the Upper Airway Microbiome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077260', 'term': 'Sleepiness'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}, {'id': 'D012913', 'term': 'Snoring'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Nasal Lavage: The nasal lavage will be performed using a spray technique. Using a disposable metered-dose inhaler (100 µl per spray), room temperature saline will be sprayed in one nostril while the other nostril is closed. After 5 sprays, the subject will gently exhale through the lavaged nostril and the fluid will be collected in a specimen cup. The procedure will be repeated a minimum of 8 times and a maximum of 15 times in each nostril. After collection, the sample will be placed on ice and processed within 2 hours.\n* Oral Rinse: Oral samples will be collected using a standardized procedure in accordance with the Manual of Procedures for Human Microbiome Project. Study participants will rinse their mouth (swish/gargle) with 15 mL sterile normal saline for 1 min, and will expectorate the contents of the mouth into a 50 mL centrifuge tube. Sample should be kept cold on ice until processing.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-10', 'studyFirstSubmitDate': '2021-11-10', 'studyFirstSubmitQcDate': '2021-11-10', 'lastUpdatePostDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Examine the incidence of post SARS-CoV-2 infection obstructive sleep apnoea (OSA) and its relationships with the upper airway/nasal microenvironment', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Determine the relationship between post- SARS-CoV-2 Infection OSA, Positive Airway Pressure (PAP) treatment adherence and change in the upper airway/nasal microenvironment.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sars-CoV2', 'microbiome', 'obstructive sleep apnea'], 'conditions': ['Sleepiness', 'SARS-CoV2 Infection', 'Fatigue Syndrome, Chronic', 'Snoring']}, 'descriptionModule': {'briefSummary': "Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) causing coronavirus disease, Covid-19, has spread rapidly across the globe since its emergence in January 2020. As of January 2021, there are 87.6 million confirmed cases worldwide, with 1.9milion deaths. In conjunction with this high disease incidence, there have also been reports of Covid-19 related sleep disordered breathing, with up 18% in a Chinese study and 57% in an Italian study of individuals with Covid-19 reporting sleep disturbance.\n\nObstructive Sleep Apnea (OSA) is a common, chronic condition due to partial or complete upper airway collapse during sleep. OSA is more common in males \\& obese individuals, both of which are more adversely affected by SARS-CoV-2 infection. Furthermore, inflammation of the upper airway, or nasal passages leading to congestion could lead to a compromised upper airway during sleep and subsequently, obstructive sleep apnea.\n\nWe believe that's SARS -CoV-2 infection, and subsequent Covid-19 will lead to an altered microbiome in the upper airway. This is turn will lead to worsening nasal inflammation and congestion, which could predispose individual with previous Covid-19 disease to OSA.\n\nAdditionally, OSA is treated with Continuous Positive Airway Pressure (CPAP) a machine which delivers pressurized air into the upper airway via a face mask. This keeps the upper airway open during sleep. When CPAP is well tolerated by individuals, it works well to reduce the symptoms of OSA. Unfortunately, many patients find it difficult to tolerate CPAP. One reason often reported for poor tolerance is nasal congestion. We believe that an altered upper airway microbiome, due to previous SARS-CoV-2 infection, will affect treatment adherence to CPAP therapy. Secondly, we will investigate if treatment with CPAP therapy causes any change in the upper airway microbiome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be selected from the Sleep Clinic and Post-Covid Clinic in Beaumont Hospital. Participants with snoring and daytime somnolence requiring sleep assessment as part of routine clinical care will be selected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms of sleepiness, fatigue, loud snoring\n\nExclusion Criteria:\n\n1. Gross skeletal alterations affecting the upper airway (eg.micrognathia)\n2. Unstable chronic medical conditions known to affect OSA (CHF, stroke) 3.\n3. Pregnancy or intent to become pregnant within the period of the protocol\n4. Inability to sign informed consent form\n5. Habitual snorer or previous diagnosis of OSA.\n6. Less than 18 years of age.'}, 'identificationModule': {'nctId': 'NCT05116657', 'briefTitle': 'Obstructive Sleep Apnoea Post Covid 19: Role of the Upper Airway Microbiome', 'organization': {'class': 'OTHER', 'fullName': 'Royal College of Surgeons, Ireland'}, 'officialTitle': 'Obstructive Sleep Apnoea Post Covid 19: Role of the Upper Airway Microbiome', 'orgStudyIdInfo': {'id': '21-031'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SARS-CoV2 OSA', 'description': 'Patients will be recruited from both Post-COVID19 and Sleep Clinics run through Beaumont Hospital, Beaumont, Dublin, Ireland. This will allow for the recruitment of patients with and without a history of SARS-CoV-2 infection.', 'interventionNames': ['Diagnostic Test: Nasal Lavage and Oral Wash']}, {'label': 'Non-SARS-CoV2 OSA', 'description': 'Patients will be recruited from both Post-COVID19 and Sleep Clinics run through Beaumont Hospital, Beaumont, Dublin, Ireland. This will allow for the recruitment of patients with and without a history of SARS-CoV-2 infection.', 'interventionNames': ['Diagnostic Test: Nasal Lavage and Oral Wash']}], 'interventions': [{'name': 'Nasal Lavage and Oral Wash', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Home Sleep Study', 'Positive Airway Pressure if diagnosed with Sleep Apnea'], 'description': '* Nasal Lavage: The nasal lavage will be performed using a spray technique. Using a disposable metered-dose inhaler (100 µl per spray), room temperature saline will be sprayed in one nostril while the other nostril is closed. After 5 sprays, the subject will gently exhale through the lavaged nostril and the fluid will be collected in a specimen cup. The procedure will be repeated a minimum of 8 times and a maximum of 15 times in each nostril. After collection, the sample will be placed on ice and processed within 2 hours.\n* Oral Rinse: Oral samples will be collected using a standardized procedure in accordance with the Manual of Procedures for Human Microbiome Project.Study participants will rinse their mouth (swish/gargle) with 15 mL sterile normal saline for 1 min, and will expectorate the contents of the mouth into a 50 mL centrifuge tube. Sample should be kept cold on ice until processing.', 'armGroupLabels': ['Non-SARS-CoV2 OSA', 'SARS-CoV2 OSA']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal College of Surgeons, Ireland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}