OTC Hearing Aid and MCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorNorthwestern University
About this trial
The goal of this study is to better understand if, in patients with mild to moderate hearing loss who are also experiencing mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD), Over-the-Counter (OTC) hearing aids:
1. improve communication 2. Whether the magnitude of benefit depends on the patient's level of cognitive disability, 3. Whether alternative remediation (such as targeted communication strategies) offer similar benefits.
Participants and a communication partner will be randomized into an OTC first or Communication Strategies first arm, where participants will receive communication strategy information customized for those with cognitive impairment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Over 60 years of age
Mild dementia or mild cognitive impairment. Diagnosis will be made at participating memory evaluation centers (see recruitment).
Mild to moderate bilateral hearing loss and no current hearing aid use.
A communication partner who is able and willing to participate in the study.
Disqualifiers
Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study.
History of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down's syndrome), or head/neck cancer
Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
Co-enrolled in other intervention studies targeting hearing, language, or communication strategies.
Trial design
Design model
Crossover
Treatments tested in this trial
Over the counter hearing aid
DeviceAn over the counter hearing aid is a device that provides amplification appropriate for individuals with mild to moderate hearing loss. Participants will receive the devices with typical directions and have one scheduled remote visit one week after receiving devices with an audiologist.
Communication Strategies Information/Counseling
BehavioralCommunication Strategies provide information meant to help an individual compensate for hearing loss. The information provides tips both for the individual with hearing loss and for those communicating. People who choose not to pursue hearing aids will typically be given communication strategies information to help them manage their hearing loss. Participants will receive the counseling information in the mail and then have a 1 week follow-up appointment with an audiologist.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: OTC Hearing Aid FirstOther 2 interventions
Group B: Communication Strategies FirstOther 2 interventions
Trial outcomes
Primary outcomes
1
Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT)
A questionnaire completed by the communication partner of the individual with MCI and hearing loss. On this scale, higher scores reflect more frequent and more problematic conversation difficulties; item possible scores range from 0 (not problematic) to 7 (.very problematic)
Time frame
Baseline at enrollment, then after 4 weeks of using each interventionSecondary outcomes
1
Hearing Handicap Inventory for the Elderly (HHIE)
Questionnaire has 25 items with subscales for social and emotional impacts and is scored from 0-100, with 100 representing least handicap.
Time frame
Baseline at enrollment, then after 4 weeks of using each interventionOther outcomes
1
Conversation Analysis
The Diapix conversation task where participant and communication partner find the differences in two very similar pictures by discussing them.
Time frame
4 weeks after first intervention2
Adherence
Reported Use (hours per day)
Time frame
4 weeks after each intervention3
Usability
We will use a modification of the Systematic Usability Scale to query the patient's experience with the OTC aids.
Time frame
4 weeks after OTC interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov