Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT04609618
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2020-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluatation of Appscent Device Safety and Effectiveness for Relief of Obstructive Sleep Apnea (OSA) Syndrome in Adults.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, self-controlled, feasibility study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-02', 'studyFirstSubmitDate': '2020-10-26', 'studyFirstSubmitQcDate': '2020-10-26', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety event frequency', 'timeFrame': '3 weeks', 'description': 'Device or treatment-related adverse events.'}], 'secondaryOutcomes': [{'measure': 'Sleepiness effect', 'timeFrame': '2 weeks', 'description': 'Overall sleepiness change measured by ESS'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep.\n\nThe standard treatment for apnea remains a device consisting of a pump and nasal mask that provide continuous positive airway pressure (CPAP). The major disadvantage of CPAP is the relatively low compliance.\n\nAppscent developed a non-contact effortless bedside solution based on the following: odors modify respiratory patterns during wake . Mildly trigeminal and pure olfactory odorants do not arouse or wake.', 'detailedDescription': 'Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep. OSA lead to desaturation and often lead to an arousal.\n\nAssociated features include loud snoring and fragmented non-refreshing sleep and have profound impact on quality of life, on safety on the roads and at work, and on the cardiovascular and metabolic systems.\n\nThe standard treatment for apnea remains a device consisting of a pump and nasal mask that provide continuous positive airway pressure (CPAP). CPAP acts as a pneumatic splint that elevates and maintains a constant pressure along the upper airway during inspiration and expiration that prevents airway collapse. The major disadvantage of CPAP is the relatively low compliance.\n\nAppscent developed a non-contact effortless bedside solution based on the following: odors modify respiratory patterns during wake . Mildly trigeminal and pure olfactory odorants do not arouse or wake. Odorants transiently presented during sleep induced a respiratory rejection type response, this suggests that manipulating the respiratory system without waking is viable .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. OSA diagnosed; AHIā„20\n2. Male and Female Aged 40 to 70 years old\n3. Patients of childbearing potential must agree to use methods of contraception and have negative pregnancy test at screening. Effective methods of contraception must be used throughout the study\n4. BMI\\< 35\n5. Patient is willing and able to give his/her written informed consent\n\nExclusion Criteria:\n\n1. Chronic lung disease (including Asthma and COPD)\n2. Congestive Heart Failure\n3. Exhibiting any flu-like or upper respiratory illness symptoms at time of assessment\n4. History of severe nasal allergies or sinusitis or difficulty breathing through the nose\n5. Persistent blockage of one or both nostrils\n6. Any previous operation or trauma to the nose\n7. Previous diagnosis of insomnia, narcolepsy, periodic limb movement disorder, respiratory failure\n8. Any use of antipsychotic, Hypnotic drugs\n9. Major neurological diagnosis\n10. Active malignant disease including chemotherapy or radiotherapy treatment\n11. Pregnant or lactating women\n12. Drug abuse\n13. Medical history of epilepsy'}, 'identificationModule': {'nctId': 'NCT04609618', 'briefTitle': 'Evaluatation of Appscent Device Safety and Effectiveness for Relief of Obstructive Sleep Apnea (OSA) Syndrome in Adults.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Y.A. Appscent Ltd.'}, 'officialTitle': 'A Prospective, Self-controlled, Feasibility Study to Evaluate Appscent Device Safety and Effectiveness for Relief of Obstructive Sleep Apnea (OSA) Syndrome in Adults.', 'orgStudyIdInfo': {'id': 'CLN001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obstructive Sleep Apnea patients', 'description': 'Appscent device will discharge odor during the in lab night sleep', 'interventionNames': ['Device: Appscent Device']}], 'interventions': [{'name': 'Appscent Device', 'type': 'DEVICE', 'description': 'computer-controlled, low pressure compressed air based, with disposable odorant capsules solution provided an odor environment at the nose,', 'armGroupLabels': ['Obstructive Sleep Apnea patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sleep Lab', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Y.A. Appscent Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}