Clinical trial NCT05970211: Early Age-Related Hearing Loss Investigation Pilot Study
Official title: Early Age-Related Hearing Loss Investigation Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial pilot is to obtain feasibility and pilot data necessary to inform the hearing intervention being designed for a larger R01 clinical trial that seeks to determine whether best practice hearing aid intervention impacts hearing-related outcomes in adults with hearing loss aged 55 to 75 years.

Secondary purposes include: To determine what effects best practice hearing aid intervention has on physical, social, and quality of life outcomes in adults with hearing loss aged 55 to 75 years.

Detailed description: This is an observational pre-post intervention feasibility study. In addition to the objective finding that adults with hearing loss experience higher rates of cognitive decline, they also tend to report lesser degrees of physical activity and increased cognitive fatigue, which is the feeling of tiredness or having a lack of energy. Unfortunately, the mechanism by which hearing loss relates to physical activity and fatigue, and the effect of hearing aids as an intervention to improve these factors, is unclear. Thus, the purpose of this study is twofold: First, we will establish the feasibility of administering a best practices hearing aid intervention to a sample of adults from the target age range of 55 - 75 years old to inform the larger clinical trial; Second, we will collect pilot data to explore the relationships between hearing loss, physical activity, socialization, fatigue and hearing-related outcomes before and after hearing aid intervention.

There are no experimental or investigational devices or agents used in this study. We are providing best-practices standard of care hearing intervention including hearing aids. We are additionally tracking activity using the ActiGraph wGT3X-BT, an FDA-approved Class II medical device that tracks continuous, high resolution physical activity and sleep/wake information.

Participation involves a minimum of 6 in-office study visits. Intervention sessions occur approximately 2 weeks apart, with a final long-term outcome session occurring approximately 6-months post the baseline intervention session.

Significant others of participants are invited to join the study and contribute data related to their own quality of life and their observations of the effects of the hearing intervention on the participant.

Eligibility criteria: Inclusion Criteria:

* Adults aged 55 to 75 years old with little or no experience with hearing aids
* English or Spanish speakers

Exclusion Criteria:

* Unable to complete written questionnaires on a tablet without assistance
* Refer for cognitive screening score based on criteria using the Mini Mental State Examination

Primary outcomes:
measure: Objective Physical Activity
timeFrame: 2-week measurement taken between 4- and 6- months post study enrollment
Secondary outcomes:
measure: Words in Noise Test
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
measure: International Outcome Inventory for Comprehensive Hearing Intervention
timeFrame: Measured at 6-months post study enrollment
measure: Client Oriented Scale of Improvement
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
measure: Hearing Handicap Inventory for Adults
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
measure: Center for Epidemiological Studies Depression and Hopelessness Scale
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
measure: Speech, Spatial and Qualities of Hearing Scale
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
measure: Social Network Index
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
measure: UCLA Loneliness Scale
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
measure: The Positive and Negative Affect Schedule
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
measure: The World Health Organization Well-Being Index
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
measure: The Vanderbilt Fatigue Scale for Adults
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
measure: Research & Development Short Form Survey (RAND36)
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
measure: Single-item sedentary questionnaire
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
measure: Modified four-square step test
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
measure: Expanded short physical performance battery
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
measure: Baecke Physical Activity Questionnaire
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
measure: PROMIS v2.0 Mobility Questionnaire
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
measure: User Experience Questionnaire+
timeFrame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
References: