Use of Amplification in Children With Unilateral Hearing Loss

NCT02269124 | Completed Results

• 2 other identifiers: 2019P00094814-006H
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Unilateral hearing loss (UHL) in children has been demonstrated to have a negative impact on quality of life, school performance and behavior. Despite this knowledge, it remains unclear how to best manage this common problem. There has been much debate regarding this issue with many programs recommending preferential seating in the classroom and use of a frequency-modulated (FM) system to amplify the teacher's voice in the classroom (conventional measures), and others recommending these accommodations in addition to use of a hearing aid for amplification (amplification). There is very limited research to support or refute the efficacy of a hearing aid in improving measurable academic, behavioral, or quality-of-life (QOL) outcomes in children with UHL. We propose a study evaluating the impact of hearing aid use in school-aged children (ages 6-12 years) with mild to moderately severe UHL. In this study, subjects will be randomized to receive either conventional measures or conventional measures plus amplification. After a three month period, the groups will be reversed, with each subject serving as their own control. Outcome measurements will include patient reported disease-specific QOL reported by patients, parents, and teachers using validated survey instruments at regular intervals throughout the study period.

Conditions

Unilateral Hearing Loss

Outcome Measures

Primary Outcomes (3)

• HEAR-QL 26 Questionnaire

  The HEAR-QL consists of 28 items that measure the perceived effect of hearing loss on quality of life. It is adjusted to a scale of 0-100, with lower scores indicating a worse disease-specific quality of life and higher scores signifying a better disease-specific quality of life. The HEAER-QL-26 was one of three surveys used to evaluate the study's primary endpoint: subject-reported quality of life.

  6 months

• CHILD (Child) Questionnaires

  The CHILD (child) questionnaire consists of 15 questions that describe situations where hearing difficulty may occur when the child is with his/her family. The answers are measured on a scale of 1-8, with 1 indicating poor ability to hear, and 8 indicating complete understanding. The total scores across all questions were standardized on a scale of 0 to 100, with lower scores indicating a worse disease-specific quality of life and higher scores signifying a better disease-specific quality of life. Two versions, the CHILD (child) and the CHILD (parent) are phrased to apply to the child and the parent respectively. The CHILD (child) was one of three surveys used to evaluate the study's primary endpoint: subject-reported quality of life.

  6 months

• LIFE-R Student Questionnaires

  The LIFE-R Student questionnaire consists of 15 questions that describe situations where hearing difficulty may occur in school. The answers are measured on a scale of 1-5, with 1 indicating situations in which hearing is always difficult and 5 indicating situations where hearing is always easy. The scores are then added standardized from 0 to 100, with lower scores representing a higher frequency of hearing difficulties in the classroom and higher score representing a lower frequency of hearing difficulties. Two versions, the LIFE-R student and the LIFE-R teacher are phrased to apply to the student and the teacher respectively. The LIFE-R Student questionnaire is one of three surveys used to evaluate the primary endpoint: subject-reported quality of life.

  6 months

Secondary Outcomes (2)

• LIFE-R Teacher

  6 months

• CHILD (Parent) Questionnaire

  6 months

Study Arms (2)

Conventional Measures Only

NO INTERVENTION

In arm 1, the child will utilize conventional measures for management of unilateral hearing loss, such as FM system and preferential seating in the classroom. While two basic types of FM systems exist, personal and sound field, subjects in our study will utilize a personal FM system, worn at the ear-level. This will increase the likelihood that the child will receive amplification in all classes, and will help to standardize this intervention. The HEAR-QL, CHILD (child) questionnaire, and LIFE-R student questionnaire will be administered to the child at the beginning, midpoint, and conclusion of this 3-month arm via Redcap. The CHILD (parent) questionnaire will be administered to the parent and the LIFE-R teacher questionnaire will be administered to the teacher at the same intervals.

Conventional Measures + Hearing Aid

EXPERIMENTAL

In arm 2, the child will use the conventional measures described above in addition to a digital behind-the-ear hearing aid with a standard ear hook and custom ear mold on the affected ear. The hearing instrument will be customized by an audiologist. The subject will be instructed to wear the hearing aid both at home and at school. In both arms, the FM system will be used in school only. As in the first arm, the HEAR-QL, CHILD (child) questionnaire, and LIFE-R student questionnaire will be administered to the child at the beginning, midpoint, and conclusion of this 3-month arm. The CHILD (parent) questionnaire will be administered to the parent and the LIFE-R teacher questionnaire will be administered to the teacher at the same intervals. No washout period will take place between the two arms. Subjects will be randomized to complete one arm first for 3 months, followed immediately by 3 months in the opposite arm.

Device: Hearing aid

Interventions

Hearing aid DEVICE

The subject will wear a hearing aid at all times for a 3-month period. At school, he/she will wear this hearing aid in addition to using conventional measures (FM system and preferential seating).

Conventional Measures + Hearing Aid

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children ages 6-12 years with mild to moderately severe unilateral hearing loss, with thresholds across 4 frequencies ≥ 25 dB but \< 70 dB in the worse hearing ear; Normal hearing in the contralateral ear, defined as thresholds ≤ 20 dB from 250 Hz to 8000 Hz; Unaided word recognition scores of ≥ 80% in worse hearing ear

You may not qualify if:

• Contralateral hearing loss; Significant cognitive impairment; Middle ear disease that has not been addressed; Inability to commit to treatment program

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Benchetrit L, Stenerson M, Ronner EA, Leonard HJ, Aungst H, Stiles DJ, Levesque PA, Kenna MA, Anne S, Cohen MS. Hearing Aid Use in Children With Unilateral Hearing Loss: A Randomized Crossover Clinical Trial. Laryngoscope. 2022 Apr;132(4):881-888. doi: 10.1002/lary.29829. Epub 2021 Aug 20.

  PMID: 34415079 DERIVED

MeSH Terms

Conditions

Hearing Loss, Unilateral

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Results Point of Contact

• Title: Dr. Michael S. Cohen, MD
• Organization: Massachusetts Eye and Ear

Michael_Cohen@MEEI.HARVARD.EDU

6175733190

Study Officials

• Michael Cohen, MD

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 20, 2014
• Study Start: October 1, 2014
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: August 11, 2021
• Results First Posted: August 11, 2021

Record last verified: 2021-07

Locations

US (1)