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Recruiting NCT04899037

Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)

— Observational Hearing Loss, Conductive Hearing Loss, Mixed Deafness, Unilateral

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Hearing Loss, Conductive, Hearing Loss, Mixed, Deafness, Unilateral. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other No intervention
    This is an observational study of participants that either choose or not choose to utilize an OID. This is not an intervention prescribed study, however, participants may choose uptake of standard of care intervention and obtain and utilize an OID. An OID is an FDA-approved device commonly recommended to patients with conductive, mixed, or singled-sided hearing loss. There is no experimental intervention evaluated in this study.

Primary outcome measures

  • 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 [Time frame: Baseline and Month 36]
  • Change from baseline to month 36 on Mini Mental State Exam scores, evaluating cognitive function ability [Time frame: Baseline and Month 36]
  • Change from baseline to month 36 on Delayed Word Recall Test scores, evaluating verbal memory [Time frame: Baseline and Month 36]
  • Change from baseline to month 36 on Digit Symbol Substitution Test scores, evaluating psychomotor speed and sustained attention [Time frame: Baseline and Month 36]
  • Change from baseline to month 36 on Incidental Learning Test scores, evaluating non-verbal recent memory [Time frame: Baseline and Month 36]
  • 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 [Time frame: Baseline and Month 36]
  • 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 [Time frame: Baseline and Month 36]
  • Change from baseline to month 36 on Logical Memory I and II scores, evaluating immediate and delayed verbal recall [Time frame: Baseline to Month 36]
  • Change from baseline to month 36 on Digit Span Backwards scores, evaluating attention and working memory [Time frame: Baseline to Month 36]
  • Change from baseline to month 36 on Boston Naming Test scores, evaluating visual naming ability [Time frame: Baseline to Month 36]
Secondary outcome measures (10)
  • Change from baseline to month 36 on Oticon SSD Questionnaire (OSSDQ) ratings, evaluating why a patient wants to use OID hearing intervention [Time frame: Baseline to Month 36]
  • Change from baseline to month 36 on Tinnitus Functional Index (TFI) ratings, evaluating the intrusiveness of tinnitus in a participant's everyday life [Time frame: Baseline to Month 36]
  • Change from baseline to month 36 on Center for Epidemiological Studies Depression and Hopelessness Scale (CES-D) ratings, which screens for clinical depression [Time frame: Baseline to Month 36]
  • Change from baseline to month 36 on Baecke Physical Activity Questionnaire (BPAQ) ratings, evaluating the frequency and duration of self report activities [Time frame: Baseline to Month 36]
  • Change from baseline to month 36 on Hearing Handicap Inventory for the Elderly (HHIE) ratings, evaluating the emotional and social impacts of hearing loss [Time frame: Baseline to Month 36]
  • Change from baseline to month 36 on SF36 Health Survey (SF-36) ratings, evaluating health related quality of life [Time frame: Baseline to Month 36]
  • Change from baseline to month 36 on Social Network Index (SNI) ratings, evaluating participant's social network [Time frame: Baseline to Month 36]
  • Change from baseline to month 36 in UCLA Loneliness Scale (UCLA - LS) ratings, evaluating participant's perception of loneliness [Time frame: Baseline to Month 36]
  • Change from baseline to month 36 on Falls and Mobility ratings, measuring self reported physical ability, fatigue, and falls [Time frame: Baseline to Month 36]
  • Change from baseline to month 36 on Number of Hospitalizations [Time frame: Baseline to Month 36]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • Department of USF Health Otolaryngology; Auditory Rehabilitation & Clinical Trials Lab — Tampa

Publications

  • Pickles JO. An introduction to the physiology of hearing. Bingley, UK: Emerald Group Publishing; 2008
  • 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.
  • 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. PMID 22083573
  • 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. PMID 21357188
  • 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. PMID 22332170
  • 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. PMID 29222544
  • 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 201 PMID 28735855
  • 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. PMID 29202654

Identifiers

NCT: NCT04899037 · STUDY001352

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗