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Active, Not Recruiting

NCT Number: NCT06051968

Effects of an Online Hearing Support for First-time Hearing Aid Users

The goal of this randomised controlled trial is to test a online hearing support for first-time hearing aid users. The main questions it aims to answer are short- and long-term effects on the emotional and social consequences of hearing loss that the participants experience, use of communications strategies, experienced listening in complex sound environments and perceived effectiveness and satisfaction with hearing aids.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hearing Loss Ear Diseases Hearing Disability Hearing Disorders Hearing Impairment Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Audiologimottagningen Lund

Lund, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults > 20 years of age that are eligible for hearing aids
  • Access to a computer, tablet and/or smartphone with internet
  • Access to a Swedish BankID or equivalent

Exclusion criteria

  • Inability to read and understand Swedish

Treatment and study plan

Online hearing support for first-time hearing aid users

Behavioral

Participants get hearing rehabilitation according to common practice and the online hearing support consists of five chapters that aim to give information, support, and advice to the new hearing aid users. The participants are assigned a new chapter between each visit at the clinic.

Other names: Stöd och Behandling för nya hörapparatanvändare, Internetbaserat stöd vid hörselrehabilitering

Hearing rehabilitation according to common practice.

Behavioral

Participants get hearing rehabilitation according to common practice.

Primary outcomes

  1. The Hearing Handicap Inventory for the Elderly (HHIE)

    Time frame: Baseline, directly post intervention and 6 months post intervention.

    Assessing changes in emotional and social effects of hearing loss, self-perceived activity limitations and participation restrictions. Minimum 0 points to maximum 100 points. Higher score indicates greater emotional and social effects of hearing loss.

Secondary outcomes

  1. The 12-item Speech, Spatial and Qualities of Hearing Scale (SSQ12)

    Time frame: Baseline, directly post intervention and 6 months post intervention.

    Assessing experience of listening in complex sound environments. Minimum 0 points to 120 points. Higher score indicates less problems with hearing in the specified situations.

  2. Communication Strategies Scale (CSS)

    Time frame: Baseline, directly post intervention and 6 months post intervention.

    Assessing changes in use of verbal, non-verbal and maladaptive communication strategies. Minimum 25 points to maximum 125 points. Higher score indicates a greater use of communication strategies.

  3. The International Outcome Inventory for Hearing Aids (IOI-HA)

    Time frame: Directly post intervention and 6 months post intervention.

    Assessing changes in perceived effectiveness and satisfaction with hearing aids.

    Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect.

Other outcomes

  1. Subjective impact of the intervention, reported by the users: Memory of the intervention

    Time frame: 6 months post intervention

    The participants are asked what they remember from their intervention.

  2. Subjective impact of the intervention, reported by the users: Seeking more or other information

    Time frame: 6 months post intervention

    The participants are asked if they searched for more or other information about hearing or hearing aids.

  3. Subjective impact of the intervention, reported by the users: Adverse effects

    Time frame: 6 months post intervention

    The participants are asked if they experienced any adverse effects of the intervention.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Horselvarden Region Ostergotland

Registry information

Official study title

Effects of an Online Hearing Rehabilitation Support for First-time Hearing Aid Users: A Randomised Controlled Trial.

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2023
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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