Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-02 @ 12:01 PM
Study NCT ID:
NCT07129668
Status:
COMPLETED
Last Update Posted:
2025-08-19
First Post:
2025-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Finger Kazoo Exercise With and Without Oropharyngeal Enlargement in the Operatic Singing Voice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055154', 'term': 'Dysphonia'}], 'ancestors': [{'id': 'D014832', 'term': 'Voice Disorders'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Fifteen classically trained singers participated in a randomized, single-blind, crossover trial with two experimental sessions separated by 48 hours. Participants were allocated via Sealed Envelope randomization to start in Condition A (without oropharyngeal expansion) or Condition B (with oropharyngeal expansion). In each session, standardised recordings were obtained before and after the intervention, including maximum phonation time for the vowels /a/ and /i/, and an operatic aria excerpt.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2025-08-15', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Jitter between conditions without and with oropharyngeal enlargement.', 'timeFrame': 'Baseline and 48 hours after first session (allowing return to baseline before second session).', 'description': 'Percentage variation in jitter between the initial and final segments of sustained vowel phonation.\n\nData Collection Method: Jitter (%) extracted from Praat software and compared between initial and final segments. ΔJitter calculated as final - initial.\n\nAnalysis Method: Robust Paired Samples T-Test. Results Summary: ΔJitter was significantly reduced in Condition B (-1.3%; p \\< .001; d = 0.54), indicating improved micro-frequency stability.'}, {'measure': 'Change in Shimmer between conditions without and with oropharyngeal enlargement.', 'timeFrame': 'Baseline and 48 hours after first session (allowing return to baseline before second session).', 'description': 'Percentage variation in shimmer between the initial and final segments of sustained vowel phonation.\n\nData Collection Method: Shimmer (%) extracted from Praat software and compared between initial and final segments. ΔShimmer calculated as final - initial.\n\nAnalysis Method: Robust Paired Samples T-Test. Results Summary: ΔShimmer was significantly reduced in Condition B (-2.1%; p \\< .001; d = 0.57), suggesting improved amplitude stability.'}], 'primaryOutcomes': [{'measure': 'Maximum Phonation Time (MPT) variation between conditions without and with oropharyngeal enlargement.', 'timeFrame': 'Baseline and 48 hours after first session (allowing return to baseline before second session).', 'description': "Assessment of the difference in maximum phonation time (in seconds) between two experimental conditions: without oropharyngeal enlargement (Condition A) and with oropharyngeal enlargement (Condition B), during sustained vowel phonation.\n\nData Collection Method: Acoustic recordings obtained using Praat software. The MPT was measured from the onset of phonation to cessation, with participants instructed to sustain the vowel at comfortable pitch and loudness.\n\nAnalysis Method: Robust Paired Samples T-Test comparing MPT between Condition A and Condition B. Effect sizes calculated using Cohen's d. Results Summary: Mean MPT was significantly higher in Condition B (+7.9 s; p \\< .001; d = 0.46), indicating improved phonatory efficiency."}], 'secondaryOutcomes': [{'measure': 'Change in Fundamental Frequency Stability (ΔF0) between conditions without and with oropharyngeal enlargement.', 'timeFrame': 'Baseline and 48 hours after first session (allowing return to baseline before second session).', 'description': 'Evaluation of the mean variation in fundamental frequency (in Hz) from onset to end of sustained vowel phonation, comparing Condition A and Condition B.\n\nData Collection Method: Praat software pitch analysis, extracting F0 mean values for initial and final 3 seconds of the sustained vowel, then calculating the difference (ΔF0).\n\nAnalysis Method: Robust Paired Samples T-Test. Results Summary: ΔF0 was significantly lower in Condition B (-7.6 Hz; p \\< .001; d = 0.39), indicating greater pitch stability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Singing Voice', 'Finger Kazoo', 'SOVTE', 'Operatic Voice'], 'conditions': ['Voice Alteration']}, 'descriptionModule': {'briefSummary': 'This clinical trial aimed to evaluate the effects of the semi-occluded vocal tract exercise Finger Kazoo (FK), with and without oropharyngeal expansion, on the singing voice. Fifteen classically trained singers, screened using the Singing Voice Handicap Index-10 (SVHI-10), participated in a randomized, single-blind, crossover trial with two experimental sessions separated by 48 hours. Participants were randomized via Sealed Envelope to start in Condition A (without oropharyngeal expansion) or Condition B (with oropharyngeal expansion). In each session, standardized recordings were obtained before and after the intervention, including maximum phonation time for the vowels /a/ and /i/, and an operatic aria excerpt. Acoustic analysis (PRAAT) extracted fundamental frequency (F0), jitter, and shimmer. Comparisons between baseline and experimental conditions were performed using paired-samples t-tests, Wilcoxon tests, robust paired t-tests, and Friedman ANOVA with Durbin-Conover, Tukey, Bonferroni, and Holm post hoc corrections, with a 95% confidence interval. Auditory-perceptual evaluation was conducted by 15 blinded experts using the EAI Scale Form, with balanced sample distribution among raters. Self-perceptual evaluation was also performed by participants using the same scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Classically trained singers aged 18 to 45 years.\n* Scoring below the cutoff for vocal handicap on the Singing Voice Handicap Index-10 (SVHI-10 ≤ 6 )\\*.\n* No history of recently vocal fold pathology or laryngeal surgery.\n* Non-smokers and no current upper respiratory infection.\n* Willingness and ability to attend two experimental sessions spaced 48 hours apart.\n\nExclusion Criteria:\n\n* Presence of any current voice disorder or history of chronic laryngeal disease.\n* Recent respiratory infection within 2 weeks prior to enrollment.\n* Use of medications affecting voice or respiratory function.\n* Inability or unwillingness to comply with study protocol.'}, 'identificationModule': {'nctId': 'NCT07129668', 'acronym': 'FIKVOX', 'briefTitle': 'Effects of Finger Kazoo Exercise With and Without Oropharyngeal Enlargement in the Operatic Singing Voice', 'organization': {'class': 'OTHER', 'fullName': 'Aveiro University'}, 'officialTitle': 'Effects of Finger Kazoo Exercise With and Without Oropharyngeal Enlargement in the Operatic Singing Voice: A Randomized, Single-Blind, Crossover Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '10-CE/2025'}, 'secondaryIdInfos': [{'id': 'doi.org/10.54499/2023.0361.BD', 'type': 'OTHER_GRANT', 'domain': 'Fundação para a Ciência e a Tecnologia'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Condition A', 'description': 'Without Oropharyngeal Enlargement', 'interventionNames': ['Behavioral: Condition A', 'Behavioral: Condition B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Condition B', 'description': 'With Oropharyngeal Enlargement', 'interventionNames': ['Behavioral: Condition A', 'Behavioral: Condition B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Condition 0 or Baseline', 'description': 'Condition 0 (Baseline) consists of producing the target vocal tasks without any semi-occlusion or intentional oropharyngeal modification just a pre vocal warmup.', 'interventionNames': ['Behavioral: Condition A', 'Behavioral: Condition B']}], 'interventions': [{'name': 'Condition A', 'type': 'BEHAVIORAL', 'otherNames': ['Whitout Oropharyngeal Enlargement'], 'description': 'Condition A consists of performing the Finger Kazoo exercise without inducing oropharyngeal enlargement. In this condition, participants place the index finger vertically in front of the lips to partially occlude the vocal tract, producing a semi-occluded vocal tract configuration, but without modifying tongue position, soft palate height, or pharyngeal wall expansion to increase the oropharyngeal space.', 'armGroupLabels': ['Condition 0 or Baseline', 'Condition A', 'Condition B']}, {'name': 'Condition B', 'type': 'BEHAVIORAL', 'otherNames': ['With Oropharyngeal Enlargement'], 'description': 'Condition B consists of performing the Finger Kazoo exercise with intentional oropharyngeal enlargement. In this condition, participants place the index finger vertically in front of the lips to partially occlude the vocal tract, producing a semi-occluded vocal tract configuration, while simultaneously modifying tongue position, elevating the soft palate, and expanding the pharyngeal walls to increase the oropharyngeal space.', 'armGroupLabels': ['Condition 0 or Baseline', 'Condition A', 'Condition B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3810-193', 'city': 'Aveiro', 'state': 'Aveiro District', 'country': 'Portugal', 'facility': 'Essua - University of Aveiro', 'geoPoint': {'lat': 40.64575, 'lon': -8.64643}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to institutional and legal restrictions on data privacy and protection as per the data protection agreement signed with the University of Aveiro.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aveiro University', 'class': 'OTHER'}, 'collaborators': [{'name': 'School of Health Sciences, University of Aveiro (ESSUA)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jean Carlos Gorges', 'investigatorAffiliation': 'Aveiro University'}}}}