21 Clinical Trials for Various Conditions
People with hearing loss experience extra effort when listening, which can lead to severe psychological barriers to communication and social participation. Listening effort can lead to fatigue, mental strain, burnout, medical sick leave, and the need for increased time to recover from regular daily activities. This proposal aims to understand effort changes on a moment-to-moment basis during listening, how long the effort lasts, and how the planning and execution of effort is impacted by the experience of using a cochlear implant.
This study will measure the performance of three personal amplification devices when used by middle-aged adults. Speech understanding will be assessed with two different types of background noises at three different input levels.
Study Objectives: * 1. To examine the extent to which noise typical of nursing units reduces speech intelligibility in acutely ill hospitalized patients * 2. To examine the extent to which noise typical of nursing units impairs recall in acutely ill hospitalized patients * 3. To quantify severity of reduced performance associated with age, familiarity with the healthcare setting, hearing and health status. Plan: One hundred and twenty inpatients from the four medical/surgical nursing units at the Portland VA Medical Center, 60 with normal hearing and 60 with hearing impairment will be recruited to participate in the study. Following assessment to ascertain eligibility and obtaining informed consent, patients will be tested in a sound booth housed at the National Center for Rehabilitative Auditory Research (NCRAR). Designed so that each patient serves as his or her own control, we can accommodate considerable baseline variability between patients without adversely affecting required sample size. Patients' performance in speech intelligibility and recall tests will be measured using a constant level of speech, in controlled environments of no noise (baseline), white noise, hospital noise and hospital noise with speech, all delivered via headphones in pseudo-random order. Performance will be measured in each type of noise at decibel levels equivalent to those currently experienced on nursing units and at lower levels that prior studies have shown are more conducive to effective communication By selecting measures that are particularly relevant to the safe care of hospitalized patients, and that have been studied extensively in healthy populations in highly controlled conditions, we expect to find compelling and unambiguous evidence that hospitalized patients correctly hear and recall very little of what is said to them during their hospitalizations. The majority of hospitalized patients stay on acute care nursing units during most or all of their hospitalizations, making this an appropriate population to study in the context of their responses to the noises typical in these environments. Perhaps most importantly, this study will heighten awareness of health-care personnel to the levels of impairment suffered by their patients - both in their ability to correctly interpret speech and to recall it - in the typical noisy environments of nursing units.
This study will examine the central regions and brain activation patterns associated with simple vocal behaviors under conditions of normal auditory feedback-when people hear themselves speak. Such feedback plays a major role in learning and maintaining human voice control. But voice control can be harmed by neurological injury or disease, reducing the ability of a person to orally communicate. Research has shown that auditory feedback is continuously monitored, brought about by both automatic and voluntary corrections in the amplitude (loudness) and frequency of (pitch) of the human voice. This study aims to determine which areas of the brain have activity dependent on the level of blood oxygen. It will provide new knowledge about basic vocal motor control and provide a basis for investigations into the integration of hearing and speaking in human vocal expression throughout life. Participants 18 to 45 years of age with normal hearing and voice function and with a steady heart rate may be eligible for this study. Participants will be evaluated by a speech-language specialist, regarding a history of voice health and measures of voice function. They will be tested on their ability to vary voice amplitude and frequency and tested on their hearing. Also, they will undergo an electrocardiogram to determine their heart rate. For the study, participants will undergo an MRI scan. During the MRI scan, patients will lie still on a table that can slide in and out of a metal cylinder surrounded by a strong magnetic field. Scanning time varies from 20 minutes to 3 hours, with most scans between 45 and 90 minutes. Patients may be asked to lie still for up to 90 minutes at a time. As the scanner takes pictures, there will be loud knocking noises, and patients will wear headphones to muffle the sound. The headphones will also enable patients to hear their voice. The patient's head will be positioned with a coil of 25 to 30 cm diameter and supported by a headrest. A microphone will be placed about 2 cm from the patient's mouth for communication and collection of data. Also, an angled mirror will be attached to the head coil, so that the patient can look outside of the scanner. By way of a projection screen, the patient will receive a visual cue to vocalize, or use his or her voice. Patients will be asked to repeatedly do some of the following vocalization tasks: (1) rest, (2) hum or sigh without voicing (exhale), (3) hum or sigh audibly, (4) hum audibly while increasing or decreasing voice frequency, and (5) hum audibly while increasing or decreasing voice amplitude. During the scan, patients will be able to communicate with the MRI staff at all times and may ask to be moved out of the machine at any time. Some scans may be done in a 3 Tesla scanner. It is the latest advance in MRI, with a stronger magnetic field than in the more common 1.5 Tesla scanner. Functional MRI is done while a person is performing tasks, such as moving a limb or speaking. The fMRI scan will take about 1 hour.
The objective of this study is to identify the influence of positive and negative auditory cues, music and a placebo (silence) on mood and gait during 30 minutes of free walking. Participants will be required to walk for a total of 30 minutes with mood being measured every 5 minutes and gait measured throughout the 30 minute protocol.
The goal of this clinical trial is to determine whether perceptual training enhances speech perception and production outcomes in children with Residual Speech Sound Disorders (RSSD). The main questions it aims to answer are: Does pre-treatment speech production accuracy predict treatment response? Does perceptual acuity influence the effectiveness of perception-first versus production-first interventions? Researchers will compare TAU+Perception-first and TAU-first treatment conditions to see if the order of intervention affects speech improvement outcomes, particularly based on participants' initial perception and production accuracy. Participants will: Complete pre-treatment evaluations to assess /r/ production and speech perception. Be grouped into high or low production and perception accuracy categories based on established thresholds. Be randomly assigned (using a blocked randomization procedure) to one of two treatment arms via telepractice. Participate in the assigned treatment condition designed to target speech sound accuracy. Randomization is stratified to ensure treatment groups are balanced based on pre-treatment severity in both the perception and production domains.
Every year, approximately 100,000 Veterans seek help at VA Audiology clinics for hearing and communication difficulties only to learn that they have normal hearing sensitivity. Unfortunately, there are very few established options to improve hearing and listening for these patients. To address this need, audiologists are increasingly prescribing hearing aids set to provide a small amount of amplification. Patients may benefit from the amplification or from modern hearing aid features such as noise reduction technology and the ability to stream sounds from a desired sound source directly to their ears thus reducing the background noise. This project will help to determine if prescribing hearing aids to patients without hearing loss is, in fact, beneficial and if so, why. It will also help to determine if some patients benefit more from hearing aids than others so that in the future, rehabilitation strategies can be better targeted toward individuals.
The objective of this study is to measure the effects of online perceptual training on perception and production in children with RSE who exhibit atypical perception relative to norms from our lab-based pilot data. In a multiple-baseline across-subjects design, 10 children with RSE will begin in a baseline phase probing perceptual acuity for /r/. Perceptual training with multiple types of stimuli will be initiated in a staggered fashion. Production probes elicited before and after treatment will assess the extent to which perception gains transfer to /r/ production.
This research will meet a public health need by evaluating the efficacy of speech intervention supplemented with real-time visual-acoustic biofeedback when delivered using remote technologies.
Hearing aids are being fit on inexperienced hearing aid users and the short-term and long-term effects are measured. This research aims to improve understanding of the individual factors that contribute to receiving benefit from hearing aids and lead to more individualized treatment of hearing loss.
The Polyvagal Theory focuses on how function and structure changed in the vertebrate autonomic nervous system during evolution. The theory is named for the vagus, a major cranial nerve that regulates bodily state. As a function of evolution, humans and other mammals have a "new" vagal pathway that links the regulation of bodily state to the control of the muscles of the face and head including the middle ear muscles. These pathways regulating body state, facial gesture, listening (i.e., middle ear muscles), and vocal communication collectively function as a Social Engagement System (SES). Because the Social Engagement System is an integrated system, interventions influencing one component of this system (e.g., middle ear muscles) may impact on the other components. Individuals with Prader-Willi Syndrome (PWS) exhibit many behaviors that are consistent with a compromised Social Engagement System. Atypical function of the Social Engagement System results in problems associated with state regulation (e.g., impulsivity, tantrums, and difficulty with change in routine), ingestion (e.g., difficulties in sucking at birth, hyperphagia), coordination of suck/swallow/breathe, intonation of vocalizations, auditory processing and hypersensitivity, and socialization. We propose to confirm that several features of the behavioral phenotype of PWS may be explained within the context of a dysfunctional SES (Specific Aim I), which may be partially rehabilitated via an intervention designed as a 'neural exercise' of the SES (Specific Aim II). Specific Aims: Aim I: To demonstrate that children with PWS have atypical regulation of the SES. We hypothesize these effects will be manifested by dampened vagal regulation of the heart (low parasympathetic tone); poor middle ear muscle regulation resulting in auditory hypersensitivities and poor auditory processing; lack of voice intonation (prosody), and difficulties in accurately detecting the emotions of others. Aim II: To demonstrate the effectiveness of the Listening Project Protocol (LPP) in decreasing the atypical features of the SES in adolescents with PWS. We hypothesize that individuals who complete the LPP will have improved vagal regulation of the heart, improved middle ear muscle regulation, increased voice intonation and improved ability to accurately detect the emotions of others.
The purpose of this study is to determine how changes in speech perception resulting from a computerized auditory training program are related to concurrent changes in auditory brainstem function resulting from the training. It is hypothesized that the degree of improvement in speech perception will be correlated with the degree of change in brainstem function.
The study is designed to examine the effectiveness of a computer-based auditory training program to improve the benefits received by individuals who wear hearing aids. The study will involve 3 groups - a computer-based training group, an active listening group which will involve listening to books on CD, and a placebo group that receives no additional treatment.
This study examined how useful it is to teach veterans coping skills for dealing with tinnitus, also called ringing in the ears. A psychological intervention, cognitive-behavioral therapy, was used to teach coping skills even though tinnitus is not a psychological disorder. Participants in Period 1 of the study were assigned to one of two groups for the duration of the study and were blinded to their group assignment until the end of the study. One group received education about tinnitus. The other group received education about tinnitus plus additional ways to cope with problems associated with tinnitus such as sleep disturbance and frustration. Participants were selected to participate if their tinnitus was severe and they had been exposed to loud sound. Participants attended up to six weekly group meetings. It was predicted that participants who were randomly assigned to the cognitive behavioral therapy group would report a greater reduction in tinnitus severity than education controls. During Period 2 of the study, a third "standard care" arm was added. Baseline and outcome data of the 4 participants who completed the study after this third arm was added to the study design are not reported.
Older adults who use cochlear implants to address hearing loss show wide variation in benefit. This research investigates the role of normal aging, the health of peripheral and central auditory pathways, and positioning of the cochlear implant electrode array in contributing to this variability. A range of input types from simple auditory signals to spoken sentences is used to examine these questions.
Medical and dental patients may experience fear commonly attributed to physical pain during the visit. By reducing pain perception, patient comfort and future patient compliance may be improved. Patient health may be improved by increasing compliance and promoting increased visits. This can lead to more frequent and timely preventative actions. The research purpose is to establish quantitative and qualitative data to support current, non-pharmacological methods for reducing pain sensitivity. More specifically, the investigators aim to determine if the use of auditory and visual (3D imaging) stimuli related to the regulation of breathing can decrease or modulate pain. Healthy participants between the ages of 18 and 60 will participate in a one week study, with two in lab appointments on day one and day seven. Participants will be split into two groups, one will undergo breathing awareness using auditory and visual technology (i.e. listen to one's own breathing with headphones and watch 3D image of lungs using virtual headset), and the second group will have breathing awareness without the use of technology (i.e. simply focusing on one's own breathing). At each appointment, the investigators will collect pain threshold data using thermal Quantitative Sensory Testing (tQST) and brain activity data using Functional near-infrared spectroscopy (fNIRS). tQST and fNIRS data will be collected before, during, and after each breathing awareness/control exercise. Quantifying change in pain intensity has been demonstrated by pain threshold comparison across a stimulus using thermal Quantitative Sensory Testing (tQST). Functional near-infrared spectroscopy (fNIRS) in coordination with pain stimulation has been shown effective at locating different hemodynamic cortical responses depending on pain perception and expectation. In the current study, functional resting states before and after pain stimulation will be quantitatively assessed using fNIRS. The study design will allow the investigators to determine if the use of auditory and visual (3D imaging) stimuli related to the regulation of breathing can decrease or modulate pain. Cortical responses will give additional insight into the areas related to the decreased pain threshold. The long term objective is to increase neurophysiological understanding that will improve patient care. If effective, the novel experimental methods used will help to standardize future pain evaluation techniques.
The overarching hypothesis to be evaluated using this protocol is that age-related hearing loss (ARHL) leads to shifts in the functional spatial boundaries between segregated and integrated auditory streams, and that hearing aid intervention that relies on directional processing schemes is most effective for those that have the poorest spatial sensitivity. One key component of the research design is to measure both behavioral and neurophysiological indices of an individual's spatial segregation boundary. The second key component is to measure the cost or benefit associated with hearing aid intervention in older hearing-impaired listeners. The final component is to relate cost and benefit of hearing aid intervention to spatial sensitivity measures that might predict the efficacy of clinical intervention.
With advancing age, adults experience increasing speech understanding difficulties in challenging situations. Currently, speech-in-noise difficulties are rehabilitated by providing hearing aids. For older normal-hearing adults, however, hearing devices do not provide much benefit since these adults do not have decreased hearing sensitivity. The goal of the "Speech Perception and High Cognitive Demand" project is to evaluate the benefit of a new auditory-cognitive training paradigm. In the present study neural (as measured by pupillometry and magnetoencephalography) and behavioral changes of speech-in-noise perception from pretest to posttest will be examined in older adults (age 65 - 85 years) assigned to one of three training groups: 1) Active Control Group: sessions of watching informational videos, 2) Auditory Training Group: sessions of auditory training listening to one of two speakers in everyday scenarios (e.g., driving directions) and needing to recall what one speaker said in the previous sentence, and 3) Auditory-cognitive training group: identical to the auditory training group, except participants will be asked to remember information from two previous sentences. Changes in speech-in-noise perception will be examined for the three groups of older adults and gains will be compared to a control group of young, normal hearing adults (18-30 years) that is not part of the clinical trial and will not undergo any training.
With advancing age, adults experience increasing speech understanding difficulties in challenging situations. Currently, speech-in-noise difficulties are rehabilitated by providing hearing aids. For older normal-hearing adults, however, hearing devices do not provide much benefit since these adults do not have a decreased hearing sensitivity. The goal of the "Speech Perception with High Cognitive Demand" Project is to evaluate the benefit of a new auditory-cognitive training paradigm. In order to provide maximal benefit for older, normal-hearing adults, a validation of the new training materials is required. In a pilot study, the investigators will evaluate the new auditory-cognitive training paradigm in 15 young, normal-hearing adults (18-30 years). Based on these results, the training paradigm can be further optimized for older adults.
Older people experience great difficulty understanding speech, especially accented English, and this problem is expected to increase with the influx of immigrants who provide services to the elderly population. The research examines the underlying factors that contribute to older listeners' difficulty understanding accented speech, including those associated with age-related hearing loss, changes in processing in auditory pathways in the brain, and general cognitive decline. The investigation also evaluates the efficacy of training strategies to improve understanding of accented English by older people. Outcomes of this research are expected to improve communication between senior citizens and those with whom they interact daily, and thereby improve quality of life for the older segment of the Nation's population.
This study compares the efficacy of low and high frequency repetitive transcranial magnetic stimulation (rTMS) as a means of treating subjects with schizophrenia. Magnetic pulses delivered over the scalp cause brain activity. This activity has been shown to help decrease the intensity and frequency of auditory hallucinations (AH) in schizophrenia. The investigators will compare whether low or high frequencies work best. The investigators will also examine what changes occur in the brain that are related to improvement.