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  • Digital Technology for Sleep and Homelessness

    Background: Disadvantaged individuals, including people experiencing homelessness, are at higher risk of getting infected, transmitting disease, and having poor health outcomes. Access to medical care, even within a system of universal health insurance like that of Canada, is decreased among people experiencing homelessness, but available evidence has demonstrated the efficacy of using telemedicine to reach vulnerable people in remote areas or people experiencing homelessness. However, at present, telemedicine-facilitated care in Canada is predominantly devoid of any technology to evaluate patient vital signals. The application of such technology to this population, if feasible, could have transformational implications for monitoring and management of such disadvantaged populations. Currently, it is known that there is a greater prevalence of chronic health diseases such as asthma, cardiology, and respiratory diseases in people experiencing homelessness. But there is no literature on the prevalence of obstructive sleep apnea (OSA) in the people experiencing homelessness. OSA is a condition characterized by repeated episodes of breathing cessation during sleep. Patients with OSA can suffer from daytime sleepiness, fatigue, and lack of energy. OSA is also associated with the conditions that account for the leading causes of mortality in adults: hypertension, cardiovascular, and cerebrovascular diseases. Seeing as the people experiencing homelessness already face many societal barriers to healthcare access, it is likely that there may exist a higher prevalence of undiagnosed OSA among the people experiencing homelessness. Rationale: From past studies, chronic diseases have been shown to be of higher prevalence in the people experiencing homelessness versus the general population, with an emphasis on a high prevalence of asthma and hypertension in the people experiencing homelessness. There is already a well-established connection between the prevalence of OSA in patients who have asthma and/or hypertension and OSA is already a highly undiagnosed condition in the general population. OSA also contributes to many other chronic health conditions. Given the strong association of hypertension and asthma with OSA, and the above average prevalence of both asthma and hypertension, among other chronic diseases, in this population, it is reasonable to infer that there might also be a high prevalence of undiagnosed OSA among the people experiencing homelessness. The use of technology and telemedicine will decrease the barriers in receiving care for people experiencing homelessness and allow for ease of access to diagnose OSA. Inclusion/Exclusion Criteria: The eligibility criteria for participants will include residing in a shelter at the time of recruitment, and being >18 years old. Participants with allergies to medical tape will be excluded from the study. For treatment protocol, exclusion criteria for mandibular advancement treatment will be dental and oral health requiring extensive dental treatment or periodontal disease with tooth mobility. Hypotheses: The investigators hypothesize that the prevalence of obstructive sleep apnea in the people experiencing homelessness will exceed that observed in the general population, as do the associated conditions of hypertension and asthma. Furthermore, the investigators hypothesize that the use of technology will help to decrease barriers in diagnosing and providing treatment for OSA. Primary Objectives: 1. Assess the prevalence of sleep apnea in shelter residents 2. Evaluate the effects of preferred sleep apnea treatment on quality of life of the people experiencing homelessness Significance: The investigators anticipate the results of this study to help lower barriers to healthcare and provide better health outcomes for people experiencing homelessness. This study will provide insight into the prevalence of OSA in people experiencing homelessness and the feasibility of using technology in telemedicine.

    Phase

    N/A

    Span

    211 weeks

    Sponsor

    University Health Network, Toronto

    Recruiting

    Healthy Volunteers

  • Clinical and Molecular Biomarker Studies in RAI1 (Retinoic Acid-Induced 1) -Related Disorders

    20 SMS (Smith-Magenis syndrome) patients and 20 PTLS (Potocki-Lupski Syndrome) patients will be enrolled in the study. Additionally, up to 50 healthy controls will be enrolled among family members of patients. All the assessments may be completed during a one-time visit at the hospital which includes an overnight stay for the sleep study for selected individuals. In case all the procedures could not be completed during the one-time visit, subjects may be asked to come again for the remaining procedure. Tests, procedures and samples to be completed or collected: - Demographics will be collected - History and physical examination: A detailed birth, medical, surgical and medication history will be collected as well as seizure and movement disorder histories. Subject chart will be reviewed to complete this data collection. A general physical examination and detailed neurological examination will be performed. - Vitals: blood pressure, temperature, respiratory rate, weight and height will be collected. - Polysomnography/electroencephalography (PSG/EEG): clinician Investigator will determine if subject is candidate for the procedure. A sleep study records the brain electrical waves, the oxygen level in the blood, heart rate and breathing, as well as eye and leg movements. Subject will need to be admitted overnight for the sleep study. The exam is video recorded. - Blood samples: A single blood sample of 15 cc (not exceeding 3 cc per kg) (~3 teaspoons) will be collected for research purposes. Samples will be kept up to 2 years after the study results are published. - Optional skin biopsy: a skin biopsy from the upper, inner arm, lateral upper thigh, or another area, may be performed for research purposes. A special 3-4 mm (0.12 inches) wide circular tool will be used to remove a small section of skin including deeper layers. A numbing cream or injectable anesthetic (i.e. lidocaine) will be applied to the area before the procedure. Sample will be used to create a cell line. This means that investigators would treat the cells from the sample in a way that allows to grow them in the laboratory. Investigators will then use these cells in research.

    Phase

    N/A

    Span

    159 weeks

    Sponsor

    Baylor College of Medicine

    Recruiting

    Healthy Volunteers

  • Pathophysiological Endotyping Using Baseline Polysomnography Data

    The site, pattern and degree of upper airway collapse is associated with the outcome of different OSA therapies. In current clinical practice, this information is assessed during DISE, in which the upper airway is evaluated during a light sedation, mimicking natural sleep. Information on the site of collapse is not currently available from routine clinical sleep studies. Recent research has shown that the site of upper airway collapse seen during endoscopy can be recognized from the distinct airflow shape patterns. For example, greater "negative effort dependence" (NED) or inspiratory scooping is associated with non-tongue-base sites of collapse. In preliminary analysis using >150 patients, the investigators recently developed a logistic regression model predicting complete concentric collapse at the level of the palate (CCCp). The model included 6 meaningful airflow features (scoopiness NED, inspiratory skewness, peak flow in early inspiration, inspiratory volume in the first 3rd of inspiration, inspiratory rise time, peak volume). Each feature is calculated as the mean value during identified hypopneas. Other sites of collapse were also assessed using the same six features in separate models (lateral walls, tongue-base, epiglottis). The study will proceed in two phases of development. In the first phase, the investigators will prospectively validate the preliminary model for predictive CCCP in 300 patients (primary outcome test for phase I). Odds for true CCCP in the predicted CCCP subgroup will be compared against the odds for CCCP in the predicted non-CCCP subgroup (Fisher exact test). Secondary analyses will validate the other three model (lateral walls, tongue-base, epiglottis). Prior to the second phase, the investigators will develop a refined model to predict CCCP using all available pooled data (N>450). The investigators will seek to include new parameters or incorporate additional interactions between predictors, where appropriate, Refined models for other sites will also be developed. Sensitivity analyses will examine different patterns of collapse (e.g. anterior-posterior), different severities (partial vs complete), how to optimally account for multi-site obstruction, and whether predicted sites are correlated. In the second phase, the investigators will prospectively apply the refined model to N=700 patients, following the same analytic approach as for phase 1. Interim analysis will be performed but the study will not be terminated for early success). Patients will undergo therapies per clinical indication and will be documented; In the entire dataset, the investigators will explore whether the presence of CCCP (per model prediction, and per DISE results) is associated with reduced efficacy of oral appliances, hypoglossal nerve stimulation, positional therapy, greater efficacy of upper airway surgery, greater CPAP pressure requirement, reduced CPAP efficacy, and reduced CPAP adherence. Associations wlil also be performed using other predicted and actual site of collapse information.

    Phase

    N/A

    Span

    209 weeks

    Sponsor

    University Hospital, Antwerp

    Recruiting

  • Home Apnea Testing in CHildren Trial

    In-lab attended polysomnography (PSG) is recommended for the diagnosis of obstructive sleep apnea (OSA) in children, but testing is limited by high cost and limited facilities. 90% of children who undergo adenotonsillectomy to treat OSA never have the diagnosis made by PSG. Home sleep apnea testing (HSAT) is an accepted means of evaluating adults for OSA. However, in children there is insufficient evidence comparing HSAT to PSG, so it is not currently recommended in the pediatric population. This single-center comparative effectiveness trial will compare the diagnostic accuracy of HSAT with PSG and will assess the agreement in therapeutic decision-making between the two tests and parent- and child-reported acceptability of HSAT and preference of test. Participants will be randomized to the initial test (HSAT or PSG) and then complete the alternate test within one week. Off-site investigators who are pediatric sleep medicine physicians will provide a therapeutic decision based on clinical data and either HSAT or PSG data, and families will complete questionnaires assessing acceptability of HSAT and preference between the two tests.

    Phase

    N/A

    Span

    227 weeks

    Sponsor

    Children's Hospital of Philadelphia

    Recruiting

  • Study of Disrupted Sleep in Somali Americans

    Phase

    N/A

    Span

    350 weeks

    Sponsor

    Mayo Clinic

    Recruiting

    Healthy Volunteers

  • ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing

    Phase

    N/A

    Span

    301 weeks

    Sponsor

    Sunnybrook Health Sciences Centre

    Recruiting

  • Gut Microbiota and Bacterial Translocation in Restless Legs Syndrome

    Sixty patients with RLS will be included and 60 controls. The patients will be recruited from the active file of the sleep and wake disorders unit. The control subjects will be recruited from : - Patients hospitalized for suspected sleep disorders with normal PSG. - The healthy controls of the RLS cognition protocol, ongoing in the department (ID-RCB: 2012-A00581-42, NCT01823354). The patients will be informed of the study during a medical consultation. The consent of subjects participating in the study will be obtained during the pre-inclusion visit (D-1). The referring physician of the patients with RLS will propose them to participate in the study. After being duly informed of the nature, significance, implications of the study and appropriately documented by one of the investigators, and after sufficient time for reflection, free, informed and written consent will be obtained from all patients. The control subjects will receive information about the study when they are admitted to hospital for polysomnographic recording, they will sign their consent for. A clinical examination will also be carried out.

    Phase

    N/A

    Span

    90 weeks

    Sponsor

    University Hospital, Montpellier

    Recruiting

    Healthy Volunteers

  • Screening Using Portable Electronic Recorders for Sleep Apnea in Hypertensive At-Risk Populations (SUPER-SHARP Trial)

    Phase

    N/A

    Span

    129 weeks

    Sponsor

    Sunnybrook Health Sciences Centre

    Recruiting

  • Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy.

    Phase

    N/A

    Span

    445 weeks

    Sponsor

    University Hospital, Strasbourg, France

    Recruiting

  • Executive Dysfunction in Restless Legs Syndrome: Clinical Correlates and Outcome After Therapeutic Management

    Phase

    N/A

    Span

    705 weeks

    Sponsor

    University Hospital, Montpellier

    Recruiting

    Healthy Volunteers

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