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Hearing impairment in Adults: a Vitals, hEmodynamics, Neuroimaging and Sleep study (HAVENS)

Hearing impairment in Adults: a Vitals, hEmodynamics, Neuroimaging and Sleep study (HAVENS)

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12626000845336
Enrollment
140
Registered
2026-07-13
Start date
2026-07-31
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

None listed

Brief summary

Hearing loss in midlife is one of the biggest modifiable risk factors for a dementia diagnosis in later life. Sleep issues are also associated with both hearing loss and dementia but the link between hearing device use, cognitive decline and sleep is poorly understood. HAVENS will address this knowledge-gap in an Australian-first prospective study that uses a combination of innovative sensing techniques to assess cognition (electroencephalogram and functional near infrared spectroscopy sensing technologies), brain health (magnetic resonance imaging), sleep (domestic sleep sensing mattress), and physiological measures (wristband oximetry sensor for heartrate, breathing rate and oxygen saturation) in adults using hearing devices (103 hearing aid and 37 cochlear implant users). This project represents a paradigm shift as it will advance understanding of the impact of hearing interventions on human health.

Interventions

Brain magnetic resonance imaging (MRI) to study brain anatomy and function - this will take approximately 30 minutes; Brain neurovascular and electrophysiological function collected with functional near-infrared spectroscopy (fNIRS) - finger tapping test (12 minutes), stroop test (11 minutes), hearing test (15 minutes) and high-density electroencephalogram (EEG) sensing technologies - karolinska drowsiness test (10 minutes), biometric data collected by different sensors (including sleep measurem

Brain magnetic resonance imaging (MRI) to study brain anatomy and function - this will take approximately 30 minutes; Brain neurovascular and electrophysiological function collected with functional near-infrared spectroscopy (fNIRS) - finger tapping test (12 minutes), stroop test (11 minutes), hearing test (15 minutes) and high-density electroencephalogram (EEG) sensing technologies - karolinska drowsiness test (10 minutes), biometric data collected by different sensors (including sleep measurements, heartrate, breathing rate and oxygen saturation) - Withings undermattress every night for 3 years, Wristox for 3 nights, and blood extractions to detect blood markers for inflammation and dementia (10 minutes). Overall, followups will occur once a year during the 3 year period of the study.

Sponsors

Macquarie University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults with hearing loss, specifically Hearing Aid users and/or Cochlear Implant recipients aged 40 years and older and residing at the Greater Sydney region.

Exclusion criteria

Participants will also be excluded for specific tests performed within this study if the criteria for those individual tests are not met. Specifically, if a participant has any cochlear implant that is not compatible with the MRI machine, or if they are/may be pregnant, they will be excluded from the MRI study.

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 23, 2026