Treatment Trials

21 Clinical Trials for Various Conditions

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COMPLETED
Perceptual Training to Improve Listeners' Ability to Understand Speech Produced by Individuals With Dysarthria
Description

There exist very few effective treatments that ease the intelligibility burden of dysarthria. Perceptual training offers a promising avenue for improving intelligibility of dysarthric speech by offsetting the communicative burden from the speaker with dysarthria on to their primary communication partners-family, friends, and caregivers. This project, utilizing advanced explanatory models, will permit identification of speaker and listener parameters, and their interactions, that allow perceptual training paradigms to be optimized for intelligibility outcomes in dysarthria rehabilitation. This work addresses this critical gap in clinical practice and sets the stage for extension of dysarthria management to listener-targeted remediation-advancing clinical practice and enhanced communication and quality of life outcomes for this population.

COMPLETED
A Comparison of Hearing Aid Noise Programs on Speech Intelligibility
Description

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.

RECRUITING
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Description

The purpose of this study is to develop and validate methods to use hearing aids equipped with embedded sensors and artificial intelligence to assist in the assessment of fall risk and in the implementation of interventions aimed at reducing the risk of falling, as well as to improve speech intelligibility in quiet and in background noise, track physical activity, and social engagement. The investigators hope is that the knowledge that is generated through this study will ultimately translate to the clinical setting and will help reduce the likelihood that individuals experience a fall, and improve the quality of hearing in individuals who wear hearing aids.

COMPLETED
Speech Intelligibility in Quiet and Noise for New vs. Legacy Hearing Aids
Description

This clinical investigation is designed to compare audiological performance (i.e., measurements of sound quality and speech understanding) between Starkey's new receiver-in-canal device and a commercially available legacy receiver-in-canal device.

COMPLETED
Benefits of Assistive Listening Device for Speech Intelligibility
Description

Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone.

Conditions
TERMINATED
Down Syndrome Speech Intelligibility Diagnostic Treatment Study
Description

The 'Down syndrome speech intelligibility diagnostic treatment study' is a pilot clinical intervention study assessing the efficacy of an integrative speech treatment approach for individuals with Down syndrome (DS). This study will use a single-subject design with 10 male participants with DS, aged 7 to 16 years. The proposed intervention, combines two treatment approaches that are documented to be efficacious with other speech disorders: 1) The Cycles Phonological Remediation Approach, designed for highly unintelligible speech, as guided by the Hodson Assessment of Phonological Patterns (HAPP-3); and 2) Script training, a functional speech motor intervention that promotes phrase-level productions. During the twelve-week intensive intervention period, both approaches will be adapted to prioritize the production of words with low vowels to incorporate increased practice of the low-front and low-back vowels. This modification is based on the investigator's perceptual, acoustic and anatomic research findings. Outcome measures will include perceptual, intelligibility, and acoustic analyses obtained from acoustic recordings. These measures will be used to assess treatment efficacy, and to gain insight into the motoric versus anatomic limitations in speech production commonly present in individuals with DS.

Conditions
COMPLETED
A Comparison of the Blom Low Profile Voice Inner Cannula and the Passy-Muir One-Way Tracheotomy Tube Speaking Valve on Voice Production, Speech Intelligibility, and Biomechanical Swallowing Behavior
Description

The main purpose of this study is to investigate voice production, speech intelligibility and routine physiologic parameters associated with the Blom low profile voice inner cannula and the Passy-Muir one-way tracheotomy tube speaking valves. Additionally, the purpose of this study is to investigate the effects (if any) associated with the Blom low profile voice inner cannula and the Passy-Muir one-way tracheotomy tube speaking valves on swallowing behavior and biomechanical movement of the hyolaryngeal complex during routine diagnostic modified barium swallowing evaluations.

COMPLETED
Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?
Description

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.

COMPLETED
Predictors of Speech Ability in Down Syndrome
Description

Speech is a critical aspect of the human experience and usually develops in a "seemingly automatic process that continues from birth through adolescence and underlies many related abilities" (e.g., language and reading, see National Academy of Medicine Report on Speech and Language Disorders, 2016). Many individuals with Down Syndrome (Trisomy 21, DS) struggle to communicate and participate more fully in human communication and educational learning experiences because their speech is difficult to understand. The purpose of the proposed project is to measure speech-articulation accuracy and speech intelligibility, and their proposed primary predictors at study entry in 20 children with DS age 6;0 to 13;11). A validated treatment, speech recast intervention (see Yoder, Camarata \& Woynaroski, 2016) will be used to drive growth in speech intelligibility as a means of evaluating changes in potential sequelae of change. This integrated study will include measures of speech-articulation accuracy, speech-prosody, general cognitive ability, receptive vocabulary skills, and clinical assay of oral-motor ability as potential predictors of speech intelligibility growth in DS. The Investigators will also be measuring suprasegmental and rhythmic factors associated with growth.

RECRUITING
Speech Perception and High Cognitive Demand
Description

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.

COMPLETED
Speech Perception With High Cognitive Demand
Description

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.

RECRUITING
Cochlear Implant Speech in Noise Processing
Description

The study will help us in understanding the neural mechanisms by which listeners with a cochlear implant detect speech in noisy environments.

RECRUITING
Benefits of Choir for Older Adults with Unaddressed Hearing Loss (WP2)
Description

Unaddressed age-related hearing loss is highly prevalent among older adults, typified by negative consequences for speech-in-noise perception and psychosocial wellbeing. There is promising evidence that group singing may enhance speech-in-noise perception and psychosocial wellbeing. However, there is a lack of robust evidence, primarily due to the literature being based on small sample sizes, single site studies, and a lack of randomized controlled trials. Hence, to address these concerns, this SingWell Project study utilizes an appropriate sample size, multisite, randomized controlled trial approach, with a robust preplanned statistical analysis. The objective of the study is to explore if group singing may improve speech-in-noise perception and psychosocial wellbeing for older adults with unaddressed hearing loss. The investigators designed an international, multisite, randomized controlled trial to explore the benefits of group singing for adults aged 60 years and older with unaddressed hearing loss. After undergoing an eligibility screening process and completing an information and consent form, the investigators intend to recruit 210 participants that will be randomly assigned to either group singing or an audiobook club (control group) intervention for a training period of 12-weeks. The study has multiple timepoints for testing, that are broadly categorized as macro (i.e., pre- and post-measures across the 12-weeks), or micro timepoints (i.e., pre- and post-measures across a weekly training session). Macro measures include behavioural measures of speech and music perception, and psychosocial questionnaires. Micro measures include psychosocial questionnaires and heart-rate variability. The investigators hypothesize that group singing may be effective at improving speech perception and psychosocial outcomes for older adults with unaddressed hearing loss-more so than participants in the control group.

COMPLETED
Facilitating Patient Communication During Noninvasive Ventilation
Description

Assessing speech intelligibility in a pilot study of patients speaking with a mask microphone while being treated with standard of care non-invasive ventilation. This is a feasibility study to test the microphone in a real world setting.

COMPLETED
MyoVoice to Restore Natural, Hands-free Communication to Individuals With Vocal Impairments
Description

This study will evaluate the ability of MyoVoice to replace natural speech. Referred to generally as an Augmentative and Alternative Communication (AAC) device, MyoVoice uses electrical signals recorded non-invasively from speech muscles (electromyographic, or EMG, signals) to restore communication for those with vocal impairments that resulted from surgical treatment of laryngeal and oropharyngeal cancers.

COMPLETED
Building Sentences With Preschoolers Who Use AAC
Description

The focus of this investigation is to compare the effectiveness of the AAC Generative Language Intervention approach to an AAC Standard of Care condition on preschool sentence productions. All children will use existing AAC iPad applications.

RECRUITING
Expiratory Muscle Strength Training for Hypernasal Speech in Children
Description

When the soft palate does not move enough because of a cleft palate or for unknown reasons, this can lead to a speech difference called velopharyngeal insufficiency. The purpose of this research study is to test if soft palate exercises using a hand help breathing device will help improve the ability of the soft palate to close the area between the throat and nose and help improve speech.

RECRUITING
Improving Spatial Perception and Speech Understanding in Multitalker Mixtures
Description

The purpose of this study is to investigate several approaches for improving spatial perception and speech intelligibility in multitalker listening situations for hearing-aid users. The hypotheses are that spatial perception and speech intelligibility will be improved by (1) increased high-frequency audibility, (2) speech envelope enhancement, and/or (3) appropriate sound image externalization.

Conditions
COMPLETED
Improve Speech Using an In-the-ear Device in Parkinson's Disease
Description

This project will systematically examine the therapeutic effect of altered auditory feedback provided by the in-the-ear device on the speech impairments in patients with Parkinson's disease. Many patients with PD have difficulty starting their speech even though they know the words they want to say. They experience 'freezing' of the jaw, tongue and lips. When they eventually get their speech started, they have a hard time moving it forward. They keep on saying the same words or phrases over and over again while their voice gets softer and softer. Many words also run together. These symptoms make patients' speech very hard to understand and directly affect their care and quality of life. Currently, there is no effective medical or surgical treatment for these speech symptoms. We have tested an in-the-ear therapeutic device that provides altered auditory feedback in eight patients with PD and moderate to severe speech impairment and the results are encouraging. We will recruit 100 patients with PD and moderate to severe speech impairment for Phase A and 20 for Phase B of the study. They will use the device routinely to provide the altered auditory feedback as they speak to improve their speech intelligibility.

RECRUITING
Listener Training for Improved Intelligibility of People with Parkinson's Disease
Description

Listener training offers a promising avenue for improving communication for people with dysarthria due to Parkinson's disease by offsetting the intelligibility burden from the patient onto their primary communication partners. Here, we employ a repeated-measures, randomized controlled trial to establish the efficacy of listener training for patients with PD and their primary communication partners. This translational work will establish a new realm of clinical practice in which the intelligibility impairments in PD are addressed by training partners to better understand dysarthric speech, thus elevating communication outcomes and participation in daily life.

RECRUITING
Subthalamic Nucleus Deep Brain Stimulation in Speech Study
Description

Parkinson's disease (PD) patients treated with deep brain stimulation (DBS) of the subthalamic nucleus (STN) have unpredictable and varied speech outcomes after this treatment. Our research will prospectively document speech performance before, during and 6- and 12-months after STN-DBS in 80 surgically treated patients and compared with 40 non-surgical controls with Parkinson's disease. This study will provide unique insights into the role of STN in speech production, document speech outcome in a comprehensive fashion, identify factors that predict functional communication ability 12 months after STN-DBS, and test the feasibility of low frequency DBS in reversing DBS-induced speech declines in order to optimize treatment strategies for those living with Parkinson's disease.