An interventional study of Over the counter hearing aid and Communication Strategies Information/Counseling in Hearing Loss, Mild Cognitive Impairment and Alzheimer Disease and Related Dementias (ADRD), sponsored by Northwestern University. Recruiting at 3 sites in United States. Open to participants aged 60 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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:
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.
This is a single blind cross-over study comparing OTC Hearing Aids to communication strategies information/counseling and their impact on communication between a person who has hearing loss and MCI and a communication partner. Due to the nature of the study, it will not be possible to blind the participants to which arm they are in, but the scorers will be blinded.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 50 is above the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be provided a pair of OTC hearing aids (experimental) with typical directions and use for 4 weeks before outcome measures will be assessed. After which, participants will then receive the communication strategies information/counseling (control) and have outcome measures assessed after 4 weeks.
Device: Over the counter hearing aid · Behavioral: Communication Strategies Information/Counseling
Participants will receive the communication strategies information/counseling intervention (control) first. Outcome measures will be assessed at 4 weeks. After which, participants will then be given a pair of OTC hearing aids (experimental) with typical directions and use for four weeks before having outcome measures assessed.
Device: Over the counter hearing aid · Behavioral: Communication Strategies Information/Counseling
An 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.
Also known as: OTC hearing aid
Communication 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.
Also known as: Communication Strategies
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 intervention
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 intervention
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 intervention
Adherence
Reported Use (hours per day)
Time frame: 4 weeks after each intervention
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 intervention
Not enrolling at this site.
Not enrolling at this site.
Started Jul 2024 (actual). Primary completion is estimated for Dec 2026, 29 months after the start.
Of 196 non-industry interventional studies with no phase under Hearing Loss, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's planned 29 months is close to that.
Counting every sponsor, half of 321 studies reached it within 19 months; a quarter within 5 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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