Listen Carefully: An Exploratory Study of the Association Between Listening Effort and Cognitive … (NCT04593290) | Clinical Trial Compass
CompletedNot Applicable
Listen Carefully: An Exploratory Study of the Association Between Listening Effort and Cognitive Function
Denmark24 participantsStarted 2020-08-08
Plain-language summary
This study aims to investigate the association between listening effort and cognitive function for both cognitively healthy individuals and for patients with Mild Cognitive Impairment (MCI) in mid-to-late stages of life, and furthermore to investigate listening effort and cognitive function after several weeks of hearing aid use. Listening effort is measured by the recording of peak pupil dilation during a sentence-final word identification and recall (SWIR) test, cognitive performance is measured using a battery of pen and paper cognitive tests, and hearing loss is measured with pure tone audiometry (PTA). A select number of participants in both the cognitively healthy and MCI group will be administered hearing aids, and the study will re-test both listening effort and cognitive performance.
Who can participate
Age range
40 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
MCI group
Inclusion Criteria:
* Is 40-85 years old;
* Has no other significant neurological or psychiatric disease;
* Has normal hearing (0 - 25 dB thresholds from 250 -6 kHz) measured using PTA;
* Has normal or corrected to normal vision;
* Has an MCI diagnosis, according to Winblad criteria, with a score on the Mini Mental State Examination (MMSE) less than or equal to 26 (MMSE ≤ 26);
* Has a CDR = 0.5;
* Speaks Danish as native language
* (For part 2 of the study - hearing aid use) has a live-in informant.
Exclusion Criteria:
* Takes medication or treatment that could impact the pupillary dilation: eye drops (e.g. atropine or phenylephrine);
* Takes medication or treatment that could impact cognitive function;
* Abuses alcohol or drugs;
* Is unable to comply with study procedures.
Cognitively healthy group:
Inclusion criteria:
* Is 40-85 years old;
* Has a score above 26 on the Mini Mental State Examination (MMSE) (MMSE \> 26);
* Has a CDR Global score = 0;
* Has no significant neurological or psychiatric disease;
* Has Normal hearing (0 - 25 dB thresholds from 250 -6 kHz) measured using PTA;
* Has Normal or corrected to normal vision;
* Speaks Danish as a native language.
Exclusion criteria:
* Meets the criteria for MCI (Winblad criteria) or dementia (ICD 10);
* Takes medication or treatment that could impact the pupillary dilation: eye drops (e.g. atropine or phenylephrine);
* Takes medication or treatment that could impact cognitive function;
* Abuses alcohol o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.