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Innovative Hearing Aid Research - Ecological Conditions and Outcome Measures (HEAR-ECO)

Innovative Hearing Aid Research - Ecological Conditions and Outcome Measures (HEAR-ECO) - HEAR-ECO

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52431
Enrollment
191
Registered
2018-09-12
Start date
2019-02-04
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hearing impairment hearing loss

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: aged between 18 and 80 years of age, native speakers of Dutch, normal or corrected-to-normal eyesight. Listeners with hearing loss should have average pure tone hearing thresholds (across 1000, 2000 and 4000 Hz) of at least 35 dB HL in both ears. We aim to include an equal number of female and male participants in each of the studies in order to improve the generalizability of the results.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: Listeners with normal hearing should have age-normal hearing (ISO 7029, 2000). General exclusion criteria: having a history of a neurological, psychiatric disease or using psychoactive drugs. Additional exclusion criteria for Studies 2, 4 and 5 (related to the cardiovascular measures collected in these studies): having a history of cardiovascular diseases, anatomic abnormalities such as: aortic valve regurgitation and defect of septum, aortic prosthesis, cardiac shunts, severe aortic sclerosis, and intra-aortic pumps or having a pacemaker. Severe hypertension (MAP > 130 mmHg), cardiac arrhythmia, tachycardia with a heart rate higher than 200 bpm, aortic balloon or aortic balloon pump. These abnormalities and dysfunctions may impede the reliable measurement of the ECG and ICG. The exclusion criteria for each of the studies except Study 2 also include (eye-) diseases such as diabetes mellitus and cataract that may influence the pupil dilation response. Additional exclusion criteria for Study 5 entail psychological disorders that may affect social skills such as disorders on the autistic spectrum and any disorders that affect social perception such as social anxiety. Furthermore, participants that have experienced extreme nausea when using virtual reality technology before this experiment will be excluded as well. Finally, because of limited space in the virtual reality head-mounted display participants cannot wear glasses. Participants who normally wear glasses and cannot substitute with contact lenses have to be excluded.

Design outcomes

Primary

MeasureTime frame
The main study parameters include the pupil dilation response and cardiovascular response (pre-ejection period [PEP] and respiratory sinus arrhythmia [RSA]) during listening to speech, as well as speech perception performance. Furthermore, subjective rating scales (experienced effort, estimated performance, and tendency to give up listening), the data of two validated questionnaires (subjective hearing difficulties, need for recovery, inclusion of other in self and group feeling) and the performance on a verbal working memory test and a symptom-validity test are part of the study parameters.

Secondary

MeasureTime frame
Blood pressure and hearing acuity.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026