Clinical trial NCT05435612: Evaluation of Rehabilitation Results in the Single-sided Deafness With Cochlear Implantation
Official title: Evaluation of Rehabilitation Results in the Single-sided Deafness/Asymmetrical Hearing Loss With Cochlear Implantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unilateral Deafness
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Single-sided deafness (SSD) refers to severe to profound sensorineural hearing loss on one side (average pure-tone hearing threshold≥70 dB HL at 0.5, 1, 2, and 4kHz) while the opposite side maintains normal hearing or mild hearing loss (30 dB HL). Asymmetrical hearing loss (AHL) refers to severe to profound sensorineural hearing loss in the bad ear (average pure-tone hearing threshold≥70 dB HL at 0.5, 1, 2, and 4kHz) and mild to moderate hearing loss in the contralateral ear. Moderate hearing loss (30≤mean pure-tone hearing threshold≤55dBHL). It is generally acknowledged that SSD is a particular clinical manifestation of AHL. The number of people who have hearing loss accounts for 5.3% of the total population, with children for 9%. According to the Second National Sampling Survey on Disabled Persons, China has 27.8 million people with hearing disabilities. The incidence of SSD adults in the United States is 7.2%, with 60,000 new cases per year, compared with 7,500 new patients with SSD annually in the UK. The incidence of SSD in neonates is 0.04%-0.34%, and it ranges from 0.1% to 0.5% in children and adolescents. The etiology of congenital SSD is primarily unknown, which is related to genes. Among the causes of acquired SSD, sudden deafness is the most common. Other causes include head trauma, Meniere's disease, labyrinthitis, unilateral acoustic neuroma, middle ear surgery, ototoxic drug exposure, Virus infection, noise-induced deafness, senile deafness, etc.

SSD and AHL impede intellectual development and speech development in children and adolescents, which is associated with the side of hearing loss. For example, children with right-sided hearing loss have relatively poor language learning, logical thinking, and divergent thinking. In contrast, children with left-sided hearing loss have weaker analytical, comprehensive and visual memory abilities and relatively poor spatial imagination and visual-motor coordination. In addition, the lack of long-term monaural listening and sound source localization makes SSD children require excessive concentration, which is prone to fatigue and behavioral problems, and their academic performance is lower than that of normal children.

Detailed description: Current options for hearing interventions for patients with SSD are air conduction hearing aids, bone conduction hearing aids and cochlear implants. Attributed to the United States Food and Drug Administration (FDA) approval of one manufacturer's CI for patients aged five years and older with SSD in 2019, CI has been considered by the growing population. However, few studies on CI in patients with SSD, especially in China. Therefore, the study aims to evaluate the efficacy of CI in SSD patients.

Eligibility criteria: Inclusion Criteria:

1. Age: 12 years old and above
2. Language ability: postlingual deafness, able to cooperate with sentence test in noise
3. Normal mental, intelligence and motor development
4. Patients who meet the diagnosis of single-sided deafness and asymmetric hearing loss

Exclusion Criteria:

1. Cochlear malformation (except large vestibular aqueduct syndrome)
2. Retrocochlear lesions
3. Incomplete implantation of cochlear implant electrodes
4. Non-Chinese Mandarin communication

Primary outcomes:
measure: speech recognition
timeFrame: The tests are conducted before the cochlear implantation.
measure: speech recognition
timeFrame: The tests are conducted 1 months after CI activation.
measure: speech recognition
timeFrame: The tests are conducted 3 months after CI activation.
measure: speech recognition
timeFrame: The tests are conducted 6 months after CI activation.
measure: speech recognition
timeFrame: The tests are conducted 12 months after CI activation.
measure: sound localization
timeFrame: The test is conducted before the cochlear implantation.
measure: sound localization
timeFrame: The test is conducted 1 months after CI activation.
measure: sound localization
timeFrame: The test is conducted 3 months after CI activation.
measure: sound localization
timeFrame: The test is conducted 6 months after CI activation.
measure: sound localization
timeFrame: The test is conducted 12 months after CI activation.
measure: Objective electroencephalography-based assessment(EEG)
timeFrame: The test is conducted before the cochlear implantation.
measure: Objective electroencephalography-based assessment(EEG)
timeFrame: The test is conducted 1 months after CI activation.
measure: Objective electroencephalography-based assessment(EEG)
timeFrame: The test is conducted 3 months after CI activation.
measure: Objective electroencephalography-based assessment(EEG)
timeFrame: The test is conducted 6 months after CI activation.
measure: Objective electroencephalography-based assessment(EEG)
timeFrame: The test is conducted 12 months after CI activation.
Secondary outcomes:
measure: THI (Tinnitus Handicap Inventory)
timeFrame: The test is conducted before the cochlear implantation.
measure: THI (Tinnitus Handicap Inventory)
timeFrame: The test is conducted 1 months after CI activation.
measure: THI (Tinnitus Handicap Inventory)
timeFrame: The test is conducted 3 months after CI activation.
measure: THI (Tinnitus Handicap Inventory)
timeFrame: The test is conducted 6 months after CI activation.
measure: THI (Tinnitus Handicap Inventory)
timeFrame: The test is conducted 12 months after CI activation.
measure: SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
timeFrame: The test is conducted before the cochlear implantation.
measure: SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
timeFrame: The test is conducted 1 months after CI activation.
measure: SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
timeFrame: The test is conducted 3 months after CI activation.
measure: SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
timeFrame: The test is conducted 6 months after CI activation.
measure: SSQ12 (Speech, Spatial and Qualities of Hearing Scale)
timeFrame: The test is conducted 12 months after CI activation.
measure: QLBHE (Quality of Life for Bilateral Hearing Effect)
timeFrame: The test is conducted before the cochlear implantation.
measure: QLBHE (Quality of Life for Bilateral Hearing Effect)
timeFrame: The test is conducted 1 months after CI activation.
measure: QLBHE (Quality of Life for Bilateral Hearing Effect)
timeFrame: The test is conducted 3 months after CI activation.
measure: QLBHE (Quality of Life for Bilateral Hearing Effect)
timeFrame: The test is conducted 6 months after CI activation.
measure: QLBHE (Quality of Life for Bilateral Hearing Effect)
timeFrame: The test is conducted 12 months after CI activation.
measure: NCIQ (Nijmegen Cochlear Implant Questionnaire)
timeFrame: The test is conducted before the cochlear implantation.
measure: NCIQ (Nijmegen Cochlear Implant Questionnaire)
timeFrame: The test is conducted 1 months after CI activation.
measure: NCIQ (Nijmegen Cochlear Implant Questionnaire)
timeFrame: The test is conducted 3 months after CI activation.
measure: NCIQ (Nijmegen Cochlear Implant Questionnaire)
timeFrame: The test is conducted 6 months after CI activation.
measure: NCIQ (Nijmegen Cochlear Implant Questionnaire)
timeFrame: The test is conducted 12 months after CI activation.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Shiming Yang, MD
role: STUDY_DIRECTOR
References: