Use of Amplification in Children With Unilateral Hearing Loss
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|ClinicalTrials.gov Identifier: NCT02269124|
Recruitment Status : Recruiting
First Posted : October 20, 2014
Last Update Posted : November 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Unilateral Hearing Loss||Device: Hearing aid||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Amplification in Children With Unilateral Hearing Loss|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
No Intervention: Conventional measures arm
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.
Experimental: Conventional measures + hearing aid arm
In the second arm, 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 a Massachusetts Eye and Ear Infirmary (MEEI) audiologist. The subject will be instructed 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.
Device: Hearing aid
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).
- HEAR-QL 26 questionnaire [ Time Frame: 3 months ]The HEAR-QL consists of 28 items that measure the perceived effect of hearing loss on the 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.
- CHILD questionnaires [ Time Frame: 3 months ]The 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 scores are added and divided by 15, giving a final score on a scale of 1-8. Two versions, the CHILD (child) and the CHILD (parent) are phrased to apply to the child and the parent respectively.
- LIFE-R questionnaires [ Time Frame: 3 months ]The LIFE-R questionnaire consists of 15 questions that describe situations where hearing difficulty may occur in school. The answers are measured on a scale of 0-5, with 1 indicating situations in which hearing is always difficult and 5 indicating situations where hearing is always easy. The scores are then added and measured overall on a scale of 0-75. Two versions, the LIFE-R student and the LIFE-R teacher are phrased to apply to the student and the teacher respectively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269124
|Contact: Evette Ronneremail@example.com|
|United States, Massachusetts|
|Massachusetts Eye and Ear Infirmary||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Evette Ronner 617-573-3576 firstname.lastname@example.org|
|Principal Investigator: Michael S Cohen, MD|
|Principal Investigator:||Michael Cohen, MD||Massachusetts Eye and Ear Infirmary|