Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-27 @ 10:53 PM
Study NCT ID:
NCT01322334
Status:
COMPLETED
Last Update Posted:
2011-03-24
First Post:
2011-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Singing Exercises to Improve Symptoms of Snoring and Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012913', 'term': 'Snoring'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-23', 'studyFirstSubmitDate': '2011-03-23', 'studyFirstSubmitQcDate': '2011-03-23', 'lastUpdatePostDateStruct': {'date': '2011-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epworth sleepiness scale', 'timeFrame': 'Entry to study (day one), and after 3 months of intervention'}], 'secondaryOutcomes': [{'measure': 'Loudness of snoring', 'timeFrame': 'Entry to study (day one), and 3 months after intervention', 'description': 'Visual analogue scale rating'}, {'measure': 'Frequency of snoring', 'timeFrame': 'Entry to study (day one), and 3 months after intervention', 'description': 'Visual analogue scale rating'}, {'measure': 'SF-36 quality of life assessment tool', 'timeFrame': 'Entry to study (day one), and 3 months after intervention'}, {'measure': 'Compliance with exercises', 'timeFrame': 'After 3 months of intervention', 'description': "Applied only to intervention group. Rated on visual analogue scale of 100mm from 'never' to 'every day'"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Snoring', 'Sleep apnea', 'Pharyngeal muscle tone'], 'conditions': ['Snoring', 'Upper Airway Resistance Syndrome', 'Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Upper airway resistance during sleep can present with a range of symptoms from simple snoring (SS) through to severe obstructive sleep apnea (OSA). Pharyngeal narrowing or collapse leads to reduction or cessation in airflow during sleep, and is associated with loud snoring.\n\nThe investigators hypothesized that regular singing exercises could strengthen pharyngeal muscles and/or increase their resting tone, and lead to an improvement of symptoms and thus quality of life in patients with all forms of snoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years old or over\n* history of simple snoring or sleep apnoea with RDI 10-40\n\nExclusion Criteria:\n\n* severe sleep apnoea RDI \\>40\n* morbid obesity BMI \\> 40\n* unable to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT01322334', 'briefTitle': 'Singing Exercises to Improve Symptoms of Snoring and Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Royal Devon and Exeter NHS Foundation Trust'}, 'officialTitle': 'A Single Blinded Prospective Randomized Controlled Trial to Investigate Whether Singing Exercises Can Improve Symptoms of Snoring and Sleep Apnea', 'orgStudyIdInfo': {'id': 'Hil2003/SE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Singing exercises', 'interventionNames': ['Behavioral: Singing exercises']}], 'interventions': [{'name': 'Singing exercises', 'type': 'BEHAVIORAL', 'description': "A 3 month self-guided treatment based on a specially designed 3CD box set, which patient performed every day ('Singing for Snorers': UK)", 'armGroupLabels': ['Singing exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EX2 5DW', 'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'Royal Devon & Exeter NHS Foundation Trust', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}], 'overallOfficials': [{'name': 'Malcolm P Hilton, BMBCh FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Devon and Exeter NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Devon and Exeter NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Malcolm Hilton', 'oldOrganization': 'Consultant Otolaryngologist and Clinical Lecturer, Royal Devon & Exeter hospital'}}}}