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NCT07461558
This study will compare two ways of managing a small, hidden hernia that can sometimes be found during minimally invasive surgery to repair a hernia on one side of the groin. Occasionally while fixing the known hernia, the surgeon discovers a small hernia on the other side that has not caused any symptoms. Surgeons do not agree on the best way to handle these hernias. Some believe it should be repaired right away during the same operation to prevent it from getting bigger or from causing symptoms later, which could require another surgery. Others believe it is better to leave it alone since it is not causing problems and groin hernia surgery carries risks including long-term pain. This study will randomly assign patients, if a hidden hernia is found during surgery, to either having it repaired immediately or to have it monitored over time. Patients will be followed up at 30 days, 1 year and 2 years following surgery. The researchers will compare recovery and quality of life between the two groups. For those in the monitoring group, the study will also track whether the hidden hernia causes symptoms or eventually needs surgery. The goal is to determine whether repairing the hidden hernia right away is as safe and effective as watching and waiting, so doctors and patients can make more informed decisions in the future.
NCT02725463
Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to loss of vestibular hair cell function. Preclinical studies have demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular prosthesis can partially restore vestibular reflexes that maintain steady posture and vision. This pilot clinical feasibility study of a multichannel vestibular implant system will evaluate this approach in up to ten human subjects with bilateral vestibular deficiency due to gentamicin ototoxicity or other causes of inner ear dysfunction.
NCT07417956
In children aged 0 to 7 years, behavioral evaluation during cochlear implant programming is often difficult or unreliable. Objective, reproducible, and rapid markers are therefore essential. While objective measures such as ECAP (electrically evoked compound action potentials) help guide safe programming, they can show inter-electrode and inter-subject variability. Electrically evoked stapedius reflex threshold (eSRT) has emerged as a relevant objective marker to approximate the comfort level of stimulation. Pediatric studies indicate that eSRT can be measured in the majority of children, closely corresponds to the comfort level, and is associated with improved speech outcomes when programming is guided by eSRT. In our previous single-center study in children aged 8 to 17 years (N=30; 44 implanted ears), eSRT was obtained in 83.3% of patients, with strong correlation between C-subjective and C-eSRT thresholds (r\>0.94; p\<0.001) across all electrodes. Tonal performance remained stable, and speech intelligibility, particularly in noise (FraSiMat), significantly improved with an eSRT-based program after one month of habituation. Daily device use remained stable, reflecting good clinical acceptability. These results support the relevance of systematic integration of eSRT in routine programming. The aim of the eSRT2 study is to evaluate the feasibility and reliability of eSRT measurement in real-world clinical care for children aged 0 to 7 years, and to monitor its stability during post-operative follow-up. Improved auditory accessibility and better-controlled acoustic comfort through eSRT are expected to accelerate speech development in children by enabling earlier improvements in vocal performance and intelligibility.
NCT06058767
Children who are deaf or hard-of-hearing (D/HH) are at risk of speech and language delays, which can be mitigated through early identification and intervention. Identifying hearing loss (HL) during preschool is crucial, but the most effective hearing screening method for preschoolers remains uncertain. The purpose of this study is to learn whether, compared to the gold-standard two-stage Pure-tone audiometry (PTA) + otoacoustic emissions (OAE) screening (TS-PO), single-stage OAE (SS-O) screening alone is not inferior at identifying hearing loss when performed in a community-based preschool setting. This study holds the potential to improve early hearing loss detection and intervention among D/HH children, reducing the likelihood of speech and language delays. A diverse group of 13,764 preschool-age children across community-based preschool centers will be recruited. The intervention involves all subjects undergoing both PTA and OAE screening, with the order determined through randomization. Children who show potential hearing issues based on screening results or teacher concerns will receive further testing to determine the final hearing outcome. Group allocation will be post-hoc, based on their screening results. In addition to the primary objective, the study will compare other hearing screening measures and outcomes between the two methods (TS-PO and SS-O). This approach aims to reflect the real-life effectiveness of hearing screening in a diverse population. Ultimately, the study seeks to provide insights into an optimal hearing screening method that could prevent speech and language delays among D/HH children.
NCT05674786
Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior research focused on ototoxic cases has demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular implant can partially restore vestibular reflexes that normally maintain steady posture and vision; improve performance on objective measures of postural stability and gait; and improve patient-reported disability and health-related quality of life. This single-arm open-label study extends that research to evaluate outcomes for up to 8 individuals with non-ototoxic bilateral vestibular hypofunction, yielding a total of fifteen adults (age 22-90 years at time of enrollment) divided as equally as possible between ototoxic and non-ototoxic cases.
NCT06641999
This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software. The Tinnitus implant is surgically placed under the skin just behind the ear in the mastoid bone. It has an electrode that extends from the implant into the promontory bone of the cochlea which emits electrical signals that stimulate the auditory nerve. The sound processor is worn behind the ear and powers the implant via the coil. The study will be conducted in adults with moderate to severe chronic tinnitus who have normal hearing to moderately severe hearing loss in the inner ear. The study participants will undergo a series of tests that include evaluations of tinnitus loudness and annoyance, and self-reported questionnaires on their tinnitus and general health.
NCT06642935
This clinical study will test a new investigational totally implanted cochlear implant system (TICI G2). The cochlear implant has an implantable microphone under the skin to detect speech and sound from the environment allowing hearing without the need of any external parts. This study will explore new ways to process the sound from the implanted microphone. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve. The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing and overall general health.
NCT04591093
Main objective: Investigate on new cochlear implanted patients whether the FineHearing strategy of the MED-EL cochlear implant gives better results on musical perception if the depth of stimulation (stimulation or not of the apical areas) is greater. Secondary objectives: Evaluate the effect of stimulation depth on vocal audiometric results, results of differential frequency threshold test and on qualitative sound perception.
NCT01628952
This is a Biomedical Research, prospective, randomized, controlled single-blind mono centric, phase IV comparison trial of the bilateral TAP block versus curare in muscle relaxation of the abdominal wall during laparoscopic digestive surgery.
NCT06860022
The proposed research addresses a long-standing and important challenge of improving literacy skills of children who are deaf and hard of hearing, a historically under researched group. The investigators aim to leverage shape coding - an empirically validated intervention approach for constructing sentences in spoken English - for improving how efficiently children who are deaf and hard of hearing learn to correctly construct sentences in written English. To advance the promising yet underutilized research on shape coding, the investigators complete the next logical step of applying the visual supports provided with shape coding to written language for deaf and hard of hearing children. Shape coding has been effective for teaching sentence structure in spoken English to children with language disabilities and has recently been applied to sentence structure in American Sign Language with deaf and hard of hearing children. Intervention involving shape coding is predicted to result in increased accuracy of word order in sentences in written English because deaf and hard of hearing children often benefit from visual information. The investigators will accomplish this aim using single case multiple probe across participants design studies with 30 fifth through eighth grade children who are deaf and hard of hearing. The knowledge gained will guide language and literacy intervention for children who are deaf and hard of hearing.
NCT06021132
The study will follow a cohort of CI-candidates becoming CI-user, till two years postoperative. A through-out assessment of both their audiological and vestibular status will be carried out at multiple fixed timepoints over 2 years, evaluating both subjective (patients reported) and objective outcomes over time. For the audiological part of the study both pure-tone and speech audiometry results will be held against the patient perceived benefit of the treatment as assessed by the questionnaires NCIQ and SSQ-12. The vestibular part of the study will evaluate the function of the SCCs and the sacculus. This is will be put in concert with functional tests of the vestibular system, and the patient perceived outcome measure DHI. Correlations between vestibular and audiological performances will be examined. A collection of specific hypotheses will be tested by predefined statistical methods.
NCT04707885
The current study is a randomized multi-center clinical trial that investigates the role an intraoperative hearing monitoring system (electrocochleography) has on helping to save residual hearing in patients undergoing cochlear implantation (CI).
NCT07161154
The study is designed as an international, multi-center, single-armed, non-interventional/observational study including subjects who has received or are planned to receive the Sentio system as part of normal clinical practice.
NCT06957730
Hearing impaired participants will be fit with study devices which will have three different hearing aid programs. Speech intelligibility will be measured using validated tests for each of the three hearing aid programs. The order of the hearing aid programs will be randomized across participants and each participant will be blinded as to the programs being tested.
NCT06154200
The purpose of this research study is to evaluate the effectiveness and safety of applying androgen sex hormone (i.e., testosterone) gel on the eyelids in the treatment of dry eye patients. Several studies have demonstrated positive treatment effects in dry eye, but few have applied testosterone gels to the eyelids.
NCT06913400
This prospective longitudinal observational study aims to assess stereopsis recovery in strabismic patients at one month and three months post-corrective surgery. The study will be conducted at Mayo Hospital, Lahore, and Sajjad Eye Center, Burewala, with a sample size of 34 using a purposive sampling technique. Eligible participants include patients aged ≥5 years undergoing strabismus surgery for esotropia, exotropia, or vertical deviations, with best-corrected visual acuity (BCVA) of 6/12 in both eyes. Patients with previous strabismus surgery, amblyopia, neurological conditions, or sensory strabismus will be excluded.
NCT06881771
FECD-TRACE is an integral component of a large research program dedicated to Fuchs Endothelial Corneal Dystrophy (FECD) in the United Kingdom. This longitudinal, observational study aims to comprehensively characterize a cohort of younger research participants who have a genetic predisposition to developing FECD. By utilizing advanced anterior segment imaging techniques, the study will monitor these individuals over a span of several years, capturing phenotypic changes that reflect the progression of the disease. Concurrently, genetic biomarkers will be examined to establish correlations with the observed phenotypic changes. The primary objective of FECD-TRACE is to enhance our understanding of the intricate genetic mechanisms underlying FECD and establish connections between these genetic findings and clinical outcomes. Ultimately, this research strives to facilitate the development of personalized care approaches for individuals affected by FECD.
NCT05402813
The purpose of this study is to follow the natural history of non-syndromic hearing loss caused by mutations in two genes (GJB2 or OTOF) in children up to 16 years of age.
NCT04728451
The purpose of this study is to compare developmental outcome for young children (12 to 35 months of age) with astigmatism meeting American Academy of Ophthalmology spectacle prescribing guidelines and who are prescribed and provided spectacles for either Full-Time wear (encouraged and reinforced) or Ad Lib wear (wear dependent on child acceptance).
NCT05230498
Main objective: Compare the recognition of environmental sounds with an anatomy-based fitting and with a default fitting adult patients newly implanted with a MED-EL cochlear implant. Secondary objectives: Compare speech recognition in quiet with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant. Compare speech recognition in noise with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.