Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2026-01-07 @ 3:17 PM
Study NCT ID:
NCT06520358
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2024-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Intermittent Hypoxia to Improve Airway Protection in Chronic Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and assessors will be blinded to group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The pilot study will utilize a double-blind, placebo-controlled, randomized-order, repeated-measures, cross-over experimental design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2024-07-19', 'studyFirstSubmitQcDate': '2024-07-24', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of laryngeal vestibule closure (dLVC)', 'timeFrame': 'Pre-intervention, 1 day after intervention block and 1-week post intervention', 'description': 'Time in (msec) the laryngeal vestibule stays closed during a swallow'}, {'measure': 'Time to laryngeal vestibule closure (Time-to-LVC)', 'timeFrame': 'Pre-intervention, 1 day after intervention block and 1-week post intervention', 'description': 'Time in (msec) it takes to close the laryngeal vestibule after swallow initiation'}], 'secondaryOutcomes': [{'measure': 'Penetration-Aspiration Scale Scores', 'timeFrame': 'Pre-intervention, 1 day after intervention block and 1-week post intervention', 'description': 'The penetration-aspiration scale (PAS) will be used to assess penetration or aspiration; the PAS is an 8-point scale that ranges from 1 (no penetration/aspiration) to 8 (aspiration with no cough response).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute intermittent hypoxia', 'rehabilitation', 'airway protection', 'dysphagia'], 'conditions': ['Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '34637802', 'type': 'BACKGROUND', 'citation': 'Vose AK, Welch JF, Nair J, Dale EA, Fox EJ, Muir GD, Trumbower RD, Mitchell GS. Therapeutic acute intermittent hypoxia: A translational roadmap for spinal cord injury and neuromuscular disease. Exp Neurol. 2022 Jan;347:113891. doi: 10.1016/j.expneurol.2021.113891. Epub 2021 Oct 9.'}, {'pmid': '32412926', 'type': 'BACKGROUND', 'citation': 'Welch JF, Sutor TW, Vose AK, Perim RR, Fox EJ, Mitchell GS. Synergy between Acute Intermittent Hypoxia and Task-Specific Training. Exerc Sport Sci Rev. 2020 Jul;48(3):125-132. doi: 10.1249/JES.0000000000000222.'}, {'pmid': '30062547', 'type': 'BACKGROUND', 'citation': 'Vose A, Humbert I. "Hidden in Plain Sight": A Descriptive Review of Laryngeal Vestibule Closure. Dysphagia. 2019 Jun;34(3):281-289. doi: 10.1007/s00455-018-9928-1. Epub 2018 Jul 30.'}]}, 'descriptionModule': {'briefSummary': 'Acute intermittent hypoxia (AIH) involves 1-2min of breathing low oxygen air to stimulate neuroplasticity. Animal and human studies show that AIH improves motor function after neural injury, particularly when paired with task-specific training. Using a double blind cross-over study we will test whether AIH and task-specific airway protection training improves airway protection more than training alone in individuals with chronic mild-moderate traumatic brain injury (TBI).', 'detailedDescription': 'Recent studies have found that acute intermittent hypoxia (AIH)-or repetitive exposure to brief episodes of low inspired oxygen--is a promising new strategy that can help restore motor function by promoting neuroplasticity throughout the central nervous system (CNS). Both rodent and human studies show that motor function is further enhanced when AIH is paired with task-specific training/rehabilitation (TST). Therefore, this study will investigate the therapeutic potential of combining AIH with a task-specific airway protection training. We propose that the combined use of AIH + TST will enhance the magnitude and duration of TST training alone in individuals with chronic traumatic brain injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 21-80 years\n* A mild to moderate traumatic brain injury (TBI) confirmed by medical records\n* A Glasgow Coma Scale score between 9-15\n* Able to consent independently\n* Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study\n\nExclusion Criteria:\n\n* Other neurological diagnoses or a diagnosis of a severe psychiatric disorder\n* Severe aphasia preventing a participant from understanding the protocol and consent form\n* Pre-existing hypoxic pulmonary disease\n* History of obstructive lung diseases such as chronic obstructive pulmonary disease (COPD) or significant asthma)\n* Severe hypertension (\\>160/100)\n* History of head and neck cancer\n* Allergy to barium sulfate\n* Ischemic cardiac disease'}, 'identificationModule': {'nctId': 'NCT06520358', 'briefTitle': 'Acute Intermittent Hypoxia to Improve Airway Protection in Chronic Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Acute Intermittent Hypoxia to Improve Airway Protection in Chronic Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'IRB202301156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AIH + TST', 'description': 'Participants will complete a 5-day intervention blocks where they receive daily AIH followed by task specific airway protection training 60 minutes after the AIH exposure. Each exposure involves a 1-minute delivery of low oxygen (9-11% inspired O2), followed by a 1.5-min interval of room air breathing (21% O2). This method of waiting 45-60 minutes after the delivery of AIH and prior to engaging in task-specific training/rehabilitation enables sufficient time to increase brain derived neurotrophic factor (BDNF) following AIH, thereby augmenting the impact of task-specific training.', 'interventionNames': ['Other: Acute Intermittent Hypoxia (AIH)', 'Behavioral: Task specific Airway Protection Training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham AIH + TST', 'description': 'Participants will complete a 5-day intervention blocks where they receive sham AIH followed by task specific airway protection training 60 minutes after the AIH sham exposure. Sham AIH will be delivered using methods identical to AIH, except a normoxic gas mixture (\\~21% O2) will be delivered. The gas mixture with normoxic air will effectively serve as a sham.', 'interventionNames': ['Behavioral: Task specific Airway Protection Training', 'Other: Sham AIH']}], 'interventions': [{'name': 'Acute Intermittent Hypoxia (AIH)', 'type': 'OTHER', 'description': 'Acute intermittent hypoxia refers to brief (acute), repetitive (intermittent) episodes of breathing oxygen-deprived air (hypoxia) alternating with breathing ambient room air.', 'armGroupLabels': ['AIH + TST']}, {'name': 'Task specific Airway Protection Training', 'type': 'BEHAVIORAL', 'otherNames': ['volitional laryngeal vestibule closure (vLVC) training'], 'description': 'The vLVC maneuver involves training participants to volitionally prolong closure of the laryngeal vestibule during swallowing, beginning with swallow onset and sustaining closure for at least 2 seconds.', 'armGroupLabels': ['AIH + TST', 'Sham AIH + TST']}, {'name': 'Sham AIH', 'type': 'OTHER', 'description': 'Sham AIH will be delivered using methods identical to AIH, except a normoxic gas mixture (\\~21% O2) will be delivered. The gas mixture with normoxic air will effectively serve as a sham.', 'armGroupLabels': ['Sham AIH + TST']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alicia Vose, PhD', 'role': 'CONTACT', 'email': 'alicia.vose@jax.ufl.edu', 'phone': '904-244-9440'}, {'name': 'Maribel Ciampitti, MS', 'role': 'CONTACT'}], 'facility': 'University of Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'centralContacts': [{'name': 'Alicia Vose, Ph.D.', 'role': 'CONTACT', 'email': 'Alicia.Vose@jax.ufl.edu', 'phone': '904-244-9092'}, {'name': 'Maribel Z Ciampitti, M.S.', 'role': 'CONTACT', 'email': 'maribel.ciampitti@jax.ufl.edu', 'phone': '904-244-4674'}], 'overallOfficials': [{'name': 'Alicia Z Vose, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}