Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT05346705
Status:
UNKNOWN
Last Update Posted:
2022-04-26
First Post:
2022-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Newly-created Individualized Upper Airway Muscle Functional Training on Patients With OSA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D009135', 'term': 'Muscular Diseases'}], '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': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep Parameters Changes : Apnea Hypopnea Index (AHI)', 'timeFrame': 'Baseline and 1 Week', 'description': 'Overnight polysomnography with Alice5 (Philips); AHI measured according to American Association of Sleep Medicine (AASM) criteria'}, {'measure': 'Sleep Parameters Changes : Oxygen desaturation index (ODI)', 'timeFrame': 'Baseline and 1 Week', 'description': 'Overnight polysomnography with Alice5 (Philips); ODI measured according to American Association of Sleep Medicine (AASM) criteria'}, {'measure': 'Sleep Parameters Changes : Snoring index', 'timeFrame': 'Baseline and 1 Week', 'description': 'Overnight polysomnography with Alice5 (Philips); Snoring index measured according to American Association of Sleep Medicine (AASM) criteria'}], 'secondaryOutcomes': [{'measure': 'Upper Airway Muscle Strength (genioglossus)', 'timeFrame': 'Baseline and 1 Week', 'description': 'Measurement of Genioglossus Strength Using the New Individualized Upper Airway Muscle Training Machine: Measuring Tongue Extension Strength (N)'}, {'measure': 'Upper Airway Muscle Strength (Soft palate muscles)', 'timeFrame': 'Baseline and 1 Week', 'description': 'Measuring Soft Palate Muscle Strength Using the New Personalized Upper Airway Muscle Training Machine: Measuring Soft Palate Muscle Resistant Pressure (kPa)'}, {'measure': 'Quality of Life (as measured by Berlin Questionnaire)', 'timeFrame': 'Baseline and 1 Week', 'description': 'The Berlin scale was used to assess the degree of risk of obstructive sleep apnea-hypopnea syndrome. The questionnaire consisted of 10 questions divided into 3 categories: snoring and apnea (5 questions); excessive daytime sleepiness or fatigue (3 questions); BMI\\>30 and history of hypertension. 2 or more positive results indicate a high risk of obstructive sleep apnea-hypopnea syndrome, which should be checked by the subjects, and then scored by the medical staff.'}, {'measure': 'Cortical motor center excitability of upper airway muscle', 'timeFrame': 'Baseline and 1 Week', 'description': 'Measured byTranscranial Magnetic Stimulation Machine (Nihon Nkohdencorp) : amplitude (mV)'}, {'measure': 'Daytime sleepiness (as measured by Epworth Sleepiness Scale)', 'timeFrame': 'Baseline and 1 Week', 'description': 'Scores on Epworth Sleepiness Scale range from range from 0 to 24, with higher scores indicating higher average sleep propensity in daily life (daytime sleepiness).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea', 'Muscle Disorder']}, 'descriptionModule': {'briefSummary': 'Objectives: To observe the effect of newly-created individualized upper airway muscle functional training on the condition and intraday symptoms of OSA patients; to study the effect of this training method on the excitability of the genioglossus muscle cortex; to analyze the factors affecting the efficacy of upper airway training in the treatment of OSA and screening suitable population for upper airway training: Design: A randomized double-blind controlled trial. SAS 9.3 statistical software (SAS Institute, Cary, North Carolina, USA) was used to generate a random number table, and the selected patients were randomly divided into experimental group 1, experimental group 2, and control group according to the ratio of 1:1:1 with 100 cases each.\n\nUnit: Shenyang, China Participants: Consecutive specific OSA patients, who are potential candidates for the treatment of upper airway training (n=300), will be recruited from a sleep center or respirologists, psychiatrists, otolaryngologists and dentists practicing with broad inclusion criteria (age: 20-75 years, AHI:15-50/h; BMI\\<40 kg/m2).\n\nInterventions: The three groups of subjects completed 7-day functional training and control training of upper airway muscles in different modes, respectively completed polysomnography, neck circumference, Berlin questionnaire and Epworth sleepiness scale before and after training, The genioglossus myoelectric activity was measured after transcranial magnetic stimulation and the excitability of the genioglossus cortex motor center was used to determine the efficacy of different training. After regression analysis, the factors affecting the efficacy of upper airway muscle group training were analyzed to screen the OSA patient population suitable for upper airway muscle group training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recent diagnosis of OSA (AHI\\>15 events/h) announced by a sleep recording\n* Mean oxygen saturation \\>90%\n* Must be able to complete the training\n\nExclusion Criteria:\n\n* Inability to tolerate overnight polysomnography in sleep lab\n* \\>50% of observed sleep apneas being central\n* Other sleep disorders such as insomnia, narcolepsy, chronic sleep deficiency, periodic limb movement disorder or restless legs syndrome'}, 'identificationModule': {'nctId': 'NCT05346705', 'briefTitle': 'Effects of Newly-created Individualized Upper Airway Muscle Functional Training on Patients With OSA', 'organization': {'class': 'OTHER', 'fullName': 'First Hospital of China Medical University'}, 'officialTitle': 'Effects of Newly-created Individualized Upper Airway Muscle Functional Training on Patients With OSA', 'orgStudyIdInfo': {'id': 'AF-SOP-07-1.1-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tongue/soft palate muscle control function training group', 'description': 'In the sleep center, patients undergo a week of upper airway muscle training for 2 hours a day under the guidance of a doctor', 'interventionNames': ['Behavioral: New individualized upper airway muscle functional training']}, {'type': 'EXPERIMENTAL', 'label': 'Soft palate muscle group vocal resistance training group', 'description': 'In the sleep center, patients undergo a week of upper airway muscle training for 2 hours a day under the guidance of a doctor', 'interventionNames': ['Behavioral: New individualized upper airway muscle functional training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Simple tongue extension, cheek drumming/voice training group', 'description': 'In the sleep center, patients undergo a week of upper airway muscle training for 2 hours a day under the guidance of a doctor', 'interventionNames': ['Behavioral: New individualized upper airway muscle functional training']}], 'interventions': [{'name': 'New individualized upper airway muscle functional training', 'type': 'BEHAVIORAL', 'description': 'The two groups of experimental groups were respectively performed tongue/soft palate muscle group control function training and soft palate muscle group vocal resistance training for 7 days.', 'armGroupLabels': ['Simple tongue extension, cheek drumming/voice training group', 'Soft palate muscle group vocal resistance training group', 'Tongue/soft palate muscle control function training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110000', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenyang Li, PhD', 'role': 'CONTACT', 'email': 'sisy_@126.com', 'phone': '15009882216'}, {'name': 'Wei Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Wenyang Li, PhD', 'role': 'CONTACT', 'email': 'sisy_@126.com', 'phone': '15009882216'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data can be requested from researchers after the experiment is over and after the paper is published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Wenyang Li', 'investigatorAffiliation': 'First Hospital of China Medical University'}}}}