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Hearing impairment in Adults: a Longitudinal Outcomes Study (HALOS)

Hearing impairment in Adults: a Longitudinal Outcomes Study (HALOS)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622000752763
Acronym
HALOS
Enrollment
740
Registered
2022-05-26
Start date
2022-08-01
Completion date
2024-05-24
Last updated
2026-06-01

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

Conditions

None listed

Brief summary

The objectives of HALOS is to: 1) evaluate the impacts of treating hearing loss on health (quality of life, cognition, depression/mood, functional status etc.), relationships, education, and work/employment outcomes. 2) examine differences in patterns/trajectories of long-term outcomes within and between groups [Hearing-aid (HA) versus Cochlear implant (CI)] of hearing device users. 3) determine the impact from the timing of intervention (initiation of HA use or implant of CI) and the effectiveness of earlier intervention on outcomes 4) evaluate the cost-effectiveness of early intervention/rehabilitation for hearing loss. Adults aged 40 years and over who use either a Hearing Aid and/or Cochlear Implant will be recruited from participating hearing service providers and hearing loss support groups. Participants will complete an online survey and brief online cognitive assessment at three time-points, (1) baseline, (2) 24-month follow-up, and (3) 48-month follow up. Audiological, health, psychosocial, and functional outcomes will be measured using validated instruments. Audiometric data will be obtained from hearing service providers for participants who have provided consent. The collected data will include audiometric thresholds, information about when the participant first presented to the clinic and the type of amplification device used. Participants will also be invited to complete a semi-structured interview at baseline only which will investigate the experiences of the patient journey and the navigation of the hearing health service pathway.

Interventions

The Hearing impairment in Adults: A Longitudinal Outcomes Study (HALOS) is a national, prospective, observational study on health and social outcomes from hearing device users (hearing aid & cochlear implant) aged 40 years and over. The HALOS study will collect audiological, health, psychosocial, cognitive and functional outcomes that will be collected cross-sectionally and longitudinally. Participants will be surveyed at three time-points, (1) baseline, (2) 24-month follow-up, and (3) 48-mont

The Hearing impairment in Adults: A Longitudinal Outcomes Study (HALOS) is a national, prospective, observational study on health and social outcomes from hearing device users (hearing aid & cochlear implant) aged 40 years and over. The HALOS study will collect audiological, health, psychosocial, cognitive and functional outcomes that will be collected cross-sectionally and longitudinally. Participants will be surveyed at three time-points, (1) baseline, (2) 24-month follow-up, and (3) 48-month follow up. Participants will be required to fill out a 60-minute online survey using REDCap at each time-point which will assess the following outcomes: 1. Demographic, medical & treatment-related details 2. Health Utilities Index-3 (HUI-3) 3. Patient-Reported Outcomes Measurement Information System-43 (PROMIS-43) 4. Social Participation Restrictions Questionnaire (SPaRQ) 5. Hearing Handicap Inventory for Screening (HHIE-S) 6. Speech, Spatial & Qualities of Hearing Scale short form (SSQ-12) 7. International Outcome Inventory for Hearing Devices (IDI-HD) 8. Attitudes towards Loss of Hearing Questionnaire (ALHQ) 9. Illness Perception Questionnaire (IPQ) 10. Falls History 11. FRAIL Scale 12. Utrecht Work Engagement Scale (UWES-9) 13. Individual Work Performance Questionnaire 14. Quantitative Job Security 15. Short-Form Unmet Needs Survey (SF-SUNS) 16. Interpersonal Relationship Functioning 17. Food Security Survey In addition to the survey, participants will complete a short 15 minute online computerised cognitive assessment using the Cogstate Brief Battery which includes 4 tests: Detection (rection time), identification test (choice reaction time), one card learning test (visual memory) and one back test (working memory). Participants will complete this unsupervised in their own homes. Audiometric data will be obtained from hearing service providers for participants who have provided consent. The collected data will include audiometric thresholds for air and bone conduction stimuli in both ears for frequencies at 0.25 to 8.0 kHz and/or four-frequency average hearing loss (4FAHL) data. When the participant first presented to the clinic and type of amplification device used will also be collected. A qualitative component will be conducted at baseline only in a subset of participants, in the form of semi-structured interviews conducted via telephone by a research assistant. This will investigate the experiences of the patient journey and the navigation of the hearing health service pathway. Participating in the interview is optional and the first 28 consenting participants (14 Hearing Aid and 14 Cochlear Implant users) will complete the interview.

Sponsors

Macquarie University
Lead SponsorUniversity

Eligibility

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

Inclusion criteria

1. Aged 40+ years 2. Wears a hearing device (Hearing Aid and/or Cochlear Implant) in at least one ear 3. Able to give informed consent

Exclusion criteria

Insufficient English language competency to complete the online survey

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 11, 2026