NCT06468137

Brief Summary

The main questions the research aims to answer are short- and long-term effects on consequences of hearing loss depending on which type of follow-up the participant chooses.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jul 2024Dec 2026

First Submitted

Initial submission to the registry

April 30, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

April 30, 2024

Last Update Submit

August 10, 2025

Conditions

Hearing LossHearing ImpairmentHearing Disorders

Outcome Measures

Primary Outcomes (1)

  • The Hearing Handicap Inventory for the Elderly (HHIE)

    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.

    Baseline, about 7 weeks post choice of intervention, and 6 months post intervention

Secondary Outcomes (5)

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

    Baseline, about 7 weeks post choice of intervention, and 6 months post intervention

  • Communication Strategies Scale (CSS)

    Baseline, about 7 weeks post choice of intervention, and 6 months post intervention

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

    Baseline, about 7 weeks post choice of intervention, and 6 months post intervention

  • Communication and Acceptance Scale (CAS)

    Baseline, about 7 weeks post choice of intervention, and 6 months post intervention

  • The International Outcome Inventory for Alternative Interventions (IOI-AI)

    Baseline, about 7 weeks post choice of intervention, and 6 months post intervention

Other Outcomes (3)

  • Subjective impact of the intervention, reported by the users: Memory of the intervention

    Time Frame: 6 months post intervention

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

    Time Frame: 6 months post intervention

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

    Time Frame: 6 months post intervention

Study Arms (3)

Swedish I-ACE

OTHER

Participants choosing to take part in the Swedish I-ACE as follow-up.

Behavioral: Swedish I-ACE

Clinical visit

OTHER

Participants choosing a clinical visit as follow-up.

Behavioral: Clinical visit

No follow-up

OTHER

Participants choosing no follow-up.

Other: No follow-up

Interventions

Swedish I-ACEBEHAVIORAL

Rehabilitative programme with focus on communication strategies and problem solving for people with hearing loss.

Swedish I-ACE
Clinical visitBEHAVIORAL

Visit in the clinic with focus on audiologic rehabilitation.

Clinical visit
No follow-upOTHER

Participants choosing no follow-up.

No follow-up

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People who have participated in NCT06051968 are automatically enrolled to participate in the follow-up according to the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Audiologimottagningen Lund

Lund, Sweden

Location

MeSH Terms

Conditions

Hearing LossHearing Disorders

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marie Öberg

    Horselvarden Region Ostergotland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2024

First Posted

June 21, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)