Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441136
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-28
Brief Title:
Characterizing the Impact of Presbyphonia on Social Interaction
Sponsor:
Matthew R Hoffman
Organization:
University of Iowa
Study Overview
Official Title:
Characterizing the Impact of Presbyphonia on Social Interaction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if presbyphonia or voice disorder caused by age-related change in the larynx is associated with change in social interaction This proposal investigates the impact of voice impairment in older adults on social interaction loneliness social disconnectedness and depression A series of questionnaires voice assessments and interviews will be performed to improve our understanding of how voice disorders affect older adults and how treatment of voice impairment with voice therapy may improve quality of life
Detailed Description:
During the study visit all subjects including the control group will be given ten questionnaires asking them to rate their loneliness and quality of life in relation to the changes in their voice All participants will undergo audiometry to assess hearing with hearing aids if used at home If they do not pass the hearing test they will be screened out of the study
Participants will then provide a required voice sample using sustained vowels for 3-5 seconds 5 times each repeating six standard sentences and 20 seconds of natural conversational speech Using this voice recording the following assessments and measurements will be obtained CAPE-V rating Consensus auditory perceptual evaluation of voice Cepstral peak prominence measurement of dysphonia fundamental frequency signal-to-noise ratio and voice type components captures breathiness
Subjects will then be asked to produce a train of pi pi pi at a comfortable pitch and loudness into a mask with an intra-oral mouthpiece to record both pressure and airflow Five trials will be performed The following measurements will be obtained mean flow rate subglottal pressure and vocal efficiency
Subjects will then undergo an awake videostroboscopy using a small flexible camera passed through the nose to view the vocal folds During this procedure the nose is anesthetized and the subject is asked to produce sustained vowels for 3-5 seconds This part of the study takes about 2 minutes to complete The parameters to be measured for this are bowing index of the vocal folds and normalized glottal gap
For the second part of this study subjects from the presbyphonia population only will be recruited to participate in the phonation resistance training exercises or PhoRTE voice therapy Prior to therapy for two weeks participants will take pictures when their voice disorder may be affecting them or ability to socialize Brief journal entry will be completed Photos will be collected printed and used as memory recall tool for a pre-treatment semi-structured interview Interviews will be conducted approximately 45-60 minutes induration Both online and in-person options will be available to facilitate participation An interview guide will include questions designed to assess participants perception of voice and how voice affects social participation
Subjects will then complete PhoRTE therapy Participants perform 5 vocal exercises at individualized target vocal intensity Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks
Following therapy participants will participate in 60-75-minute semi-structured small group interviews approximately 3 months after voice therapy Interviews will address experience with voice therapy and any changes after voice therapy
Participants will then provide a required voice sample using sustained vowels for 3-5 seconds 5 times each repeating six standard sentences and 20 seconds of natural conversational speech Using this voice recording the following assessments and measurements will be obtained CAPE-V rating Consensus auditory perceptual evaluation of voice Cepstral peak prominence measurement of dysphonia fundamental frequency signal-to-noise ratio and voice type components captures breathiness
Subjects will then be asked to produce a train of pi pi pi at a comfortable pitch and loudness into a mask with an intra-oral mouthpiece to record both pressure and airflow Five trials will be performed The following measurements will be obtained mean flow rate subglottal pressure and vocal efficiency
Subjects will then undergo an awake videostroboscopy using a small flexible camera passed through the nose to view the vocal folds During this procedure the nose is anesthetized and the subject is asked to produce sustained vowels for 3-5 seconds This part of the study takes about 2 minutes to complete The parameters to be measured for this are bowing index of the vocal folds and normalized glottal gap
For the second part of this study subjects from the presbyphonia population only will be recruited to participate in the phonation resistance training exercises or PhoRTE voice therapy Prior to therapy for two weeks participants will take pictures when their voice disorder may be affecting them or ability to socialize Brief journal entry will be completed Photos will be collected printed and used as memory recall tool for a pre-treatment semi-structured interview Interviews will be conducted approximately 45-60 minutes induration Both online and in-person options will be available to facilitate participation An interview guide will include questions designed to assess participants perception of voice and how voice affects social participation
Subjects will then complete PhoRTE therapy Participants perform 5 vocal exercises at individualized target vocal intensity Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks
Following therapy participants will participate in 60-75-minute semi-structured small group interviews approximately 3 months after voice therapy Interviews will address experience with voice therapy and any changes after voice therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None