Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249685
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2024-01-31
Brief Title:
Does Wearing Hearing Aids Impact the Affective State of Older Adults With Hearing Loss in Their Daily Lives
Sponsor:
University of Memphis
Organization:
University of Memphis
Study Overview
Official Title:
Does Wearing Hearing Aids Impact the Affective State of Older Adults With Hearing Loss in Their Daily Lives
Status:
COMPLETED
Status Verified Date:
2024-01
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 proposed field trial will clarify the real-world effectiveness of HAs in remediating deficits in emotion processing for older adults with mild-to-moderate hearing loss This study will employ a repeated reversal design to establish baseline affective state without HAs when wearing amplification and after HAs are removed This study will triangulate self-report behavioral and physiological measures to capture nuances of emotional processing in the laboratory and in daily listening Naturalistic stimuli will be used as it occurs in daily life to elicit emotional experiences and ecological momentary assessment and commercially-available wearable sensors will be used to track changes in emotional state in daily listening Anchoring real-world emotional experiences with controlled laboratory experiences will validate wearable sensors Additionally laboratory emotional stimuli will be related to real-world emotional experiences to establish the utility of laboratory stimuli in future studies It is likely that benefits in emotional processing will have differential effects based on individual characteristics such as degree of hearing loss age gender cognitive ability and personality so participants will be analyzed according to larger groupings based on individual differences
Detailed Description:
Thirty-five participants will complete preliminary measures including assessments of routine audiometrics demographics personality and working memory For each arm of the trial baseline-unaided aided follow-up unaided participants will be issued sensors to use while pursuing normal daily life activities These sensors can provide information such as heart rate HR and respiration activity which have been associated with the arousal dimension of emotion Participants also will download a mobile app that will automatically prompt them throughout their day to indicate their perceived arousal and valence and listening-related workload For each arm of the trial interindividual and intraindividual emotion perception speech understanding and perceived workload will be also be assessed using laboratory-based self-report behavioral and physiological measures Subjective measures of hearing aid benefit emotional consequences of hearing loss and the effect of hearing loss on emotional communication will be assessed through validated questionnaires at the conclusion of each arm of the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None