Clinical trial NCT04899037: Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)
Official title: Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Loss, Conductive
Hearing Loss, Mixed
Deafness, Unilateral
Keywords: osseointegrated device
cognition
hearing loss
neurocognitive
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Oticon Medical
First posted: 2021-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults age 18-85 years with an audiometric configuration (conductive or mixed hearing loss, single sided deafness) would could benefit from an OID hearing intervention

Brief summary: The primary objective of the study is to evaluate OID hearing intervention on cognition among patients who could vs. do utilize an OID. We will also evaluate the long-term effects of OID use on secondary outcomes measures (hearing performance, quality-of-life, social interaction, communication, physical functioning, etc)

Detailed description: Hearing impairment is highly prevalent and independently associated with cognitive decline. Little is known about the various types, degrees, and configurations of hearing loss and how it relates to uptake of a hearing intervention and possible long-term benefits of using the intervention. The purpose of this study is to investigate the comparative effectiveness within an observational study design to determine the long-term effects of hearing intervention, in the form of osseointegrated devices (OID), among patients with either conductive, mixed, or single-sided hearing loss. Participants will be followed for 3 years (36 months) to answer the following aims:

Aim 1: To compare the effect of OID intervention versus no audiological intervention on rates of decline in global cognitive function (primary outcome measure) in 18-85 year-old well-functioning and cognitively-normal older adults with hearing loss. We hypothesize that there will be a significant difference in cognitive function between patients that utilized OID hearing intervention compared to no audiological intervention.

Secondary Aims: To compare the effect of OID intervention on secondary outcomes of hearing, social, mental, physical, and cognitive functioning. We hypothesize that there are significant differences in secondary outcomes between patients that utilized OID hearing intervention compared to no audiological intervention.

Eligibility criteria: Inclusion Criteria:

* age 18-85 years
* community dwelling
* residency: participants must plan to reside in the local area for the study duration.
* fluent English-speaker
* Audiometric hearing impairment: participants must have hearing configuration that could benefit from OID hearing intervention.
* Mini-Mental State Exam (MMSE) score \> 23 for individuals with high-school degree or less; Mini-Mental State Exam (MMSE) score \>25 for individuals with some college or more; participants must be at risk for cognitive decline the range quantified well by neurocognitive testing, and so must be free from more substantial cognitive impairment at baseline.
* willingness to participant and adhere to the protocol: participants must be willing and able to consent to participate in the study and be willing to commit to adhere to the study protocol for the duration of the study (3 years)

Exclusion Criteria:

* self-reported disability in \>2 or more Activities of Daily Living (ADL)
* medical contraindication to use of OID; because OIDs will be the primary device used in the hearing intervention, participants with medical contraindications to OID use are excluded

Primary outcomes:
measure: Change from baseline to month 36 on Ensuring Speech Understanding Test scores, evaluating a participants ability to hear the examiner during the Neurocognitive Test Battery
timeFrame: Baseline and Month 36
measure: Change from baseline to month 36 on Mini Mental State Exam scores, evaluating cognitive function ability
timeFrame: Baseline and Month 36
measure: Change from baseline to month 36 on Delayed Word Recall Test scores, evaluating verbal memory
timeFrame: Baseline and Month 36
measure: Change from baseline to month 36 on Digit Symbol Substitution Test scores, evaluating psychomotor speed and sustained attention
timeFrame: Baseline and Month 36
measure: Change from baseline to month 36 on Incidental Learning Test scores, evaluating non-verbal recent memory
timeFrame: Baseline and Month 36
measure: Change from baseline to month 36 on Trail Making Test Part A (TMT A) scores, evaluating attention, sequencing, mental flexibility, visual search, and motor function
timeFrame: Baseline and Month 36
measure: Change from baseline to month 36 on Trail Making Test Part B (TMT B) scores, evaluating attention, sequencing, mental flexibility, visual search, and motor function
timeFrame: Baseline and Month 36
measure: Change from baseline to month 36 on Logical Memory I and II scores, evaluating immediate and delayed verbal recall
timeFrame: Baseline to Month 36
measure: Change from baseline to month 36 on Digit Span Backwards scores, evaluating attention and working memory
timeFrame: Baseline to Month 36
measure: Change from baseline to month 36 on Boston Naming Test scores, evaluating visual naming ability
timeFrame: Baseline to Month 36
measure: Change from baseline to month 36 on Word Fluency Test scores, evaluating verbal functioning
timeFrame: Baseline to Month 36
measure: Change from baseline to month 36 on Animal Naming Test scores, evaluating category fluency
timeFrame: Baseline to Month 36
Secondary outcomes:
measure: Change from baseline to month 36 on Oticon SSD Questionnaire (OSSDQ) ratings, evaluating why a patient wants to use OID hearing intervention
timeFrame: Baseline to Month 36
measure: Change from baseline to month 36 on Tinnitus Functional Index (TFI) ratings, evaluating the intrusiveness of tinnitus in a participant's everyday life
timeFrame: Baseline to Month 36
measure: Change from baseline to month 36 on Center for Epidemiological Studies Depression and Hopelessness Scale (CES-D) ratings, which screens for clinical depression
timeFrame: Baseline to Month 36
measure: Change from baseline to month 36 on Baecke Physical Activity Questionnaire (BPAQ) ratings, evaluating the frequency and duration of self report activities
timeFrame: Baseline to Month 36
measure: Change from baseline to month 36 on Hearing Handicap Inventory for the Elderly (HHIE) ratings, evaluating the emotional and social impacts of hearing loss
timeFrame: Baseline to Month 36
measure: Change from baseline to month 36 on SF36 Health Survey (SF-36) ratings, evaluating health related quality of life
timeFrame: Baseline to Month 36
measure: Change from baseline to month 36 on Social Network Index (SNI) ratings, evaluating participant's social network
timeFrame: Baseline to Month 36
measure: Change from baseline to month 36 in UCLA Loneliness Scale (UCLA - LS) ratings, evaluating participant's perception of loneliness
timeFrame: Baseline to Month 36
measure: Change from baseline to month 36 on Falls and Mobility ratings, measuring self reported physical ability, fatigue, and falls
timeFrame: Baseline to Month 36
measure: Change from baseline to month 36 on Number of Hospitalizations
timeFrame: Baseline to Month 36
Other outcomes:
measure: Change from baseline to month 36 on the Audiometric Assessment, evaluating pure tone and speech audiometric abilities
timeFrame: Baseline to Month 36
Locations:
city: Tampa
country: United States
facility: Department of USF Health Otolaryngology; Auditory Rehabilitation & Clinical Trials Lab
state: Florida
Study officials:
affiliation: University of South Florida
name: Victoria Sanchez, Au.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: Morgan Oktela, Au.D
role: STUDY_DIRECTOR
References:
citation: Pickles JO. An introduction to the physiology of hearing. Bingley, UK: Emerald Group Publishing; 2008
citation: WHO. World Health Organization Prevention of Blindness and Deafness (PBD) Program. Prevention of Deafness and Hearing Impaired Grades of Hearing Impairment. <http://www.who.int/pbd/deafness/hearing_impairment_grades/en/index.html>.In.
citation: Lin FR, Niparko JK, Ferrucci L. Hearing loss prevalence in the United States. Arch Intern Med. 2011 Nov 14;171(20):1851-2. doi: 10.1001/archinternmed.2011.506. No abstract available.
citation: Lin FR, Thorpe R, Gordon-Salant S, Ferrucci L. Hearing loss prevalence and risk factors among older adults in the United States. J Gerontol A Biol Sci Med Sci. 2011 May;66(5):582-90. doi: 10.1093/gerona/glr002. Epub 2011 Feb 27.
citation: Chien W, Lin FR. Prevalence of hearing aid use among older adults in the United States. Arch Intern Med. 2012 Feb 13;172(3):292-3. doi: 10.1001/archinternmed.2011.1408. No abstract available.
citation: Loughrey DG, Kelly ME, Kelley GA, Brennan S, Lawlor BA. Association of Age-Related Hearing Loss With Cognitive Function, Cognitive Impairment, and Dementia: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2018 Feb 1;144(2):115-126. doi: 10.1001/jamaoto.2017.2513.
citation: Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, Ballard C, Banerjee S, Burns A, Cohen-Mansfield J, Cooper C, Fox N, Gitlin LN, Howard R, Kales HC, Larson EB, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care. Lancet. 2017 Dec 16;390(10113):2673-2734. doi: 10.1016/S0140-6736(17)31363-6. Epub 2017 Jul 20. No abstract available.
citation: Rutherford BR, Brewster K, Golub JS, Kim AH, Roose SP. Sensation and Psychiatry: Linking Age-Related Hearing Loss to Late-Life Depression and Cognitive Decline. Am J Psychiatry. 2018 Mar 1;175(3):215-224. doi: 10.1176/appi.ajp.2017.17040423. Epub 2017 Dec 5.
citation: Lin FR, Albert M. Hearing loss and dementia - who is listening? Aging Ment Health. 2014;18(6):671-3. doi: 10.1080/13607863.2014.915924. No abstract available.
citation: Reed NS, Altan A, Deal JA, Yeh C, Kravetz AD, Wallhagen M, Lin FR. Trends in Health Care Costs and Utilization Associated With Untreated Hearing Loss Over 10 Years. JAMA Otolaryngol Head Neck Surg. 2019 Jan 1;145(1):27-34. doi: 10.1001/jamaoto.2018.2875.
citation: Deal JA, Goman AM, Albert MS, Arnold ML, Burgard S, Chisolm T, Couper D, Glynn NW, Gmelin T, Hayden KM, Mosley T, Pankow JS, Reed N, Sanchez VA, Richey Sharrett A, Thomas SD, Coresh J, Lin FR. Hearing treatment for reducing cognitive decline: Design and methods of the Aging and Cognitive Health Evaluation in Elders randomized controlled trial. Alzheimers Dement (N Y). 2018 Oct 5;4:499-507. doi: 10.1016/j.trci.2018.08.007. eCollection 2018.
citation: Tjellstrom A, Granstrom G. Long-term follow-up with the bone-anchored hearing aid: a review of the first 100 patients between 1977 and 1985. Ear Nose Throat J. 1994 Feb;73(2):112-4.