Genomics Registry Study
The purpose of this project is to develop a registry limited to patients with respiratory and sleep related diseases. Reasons for developing this particular database include: (1) identifying patients, especially specific subgroups (e.g. specific treatment regimens, co-existing illnesses) to contact for upcoming and/or active studies; (2) improved understanding of the populations we are accessing for studies; (3) developing future research protocols (e.g. source of well characterized patients for proposal development); and (4) clinical and quality improvement purposes (e.g. standardizing site-specific treatment protocols).
The proposed pulmonary and sleep patient registry will be:
> Inclusive: All patients with a diagnosis of respiratory and sleep-related diseases will be asked to enroll.
> Short and Simple: Each patient will be enrolled only once, preferably at their first visit with their pulmonary specialist provider and assigned a unique identifier.
> Inexpensive: The costs, including personnel for data entry, will be minimal and absorbed by the Department of Medicine, Pulmonary Division.
Predictive Analytics and Peer-Driven Intervention for Guideline-Based Care for Sleep Apnea
Fragmentation of care can lead to poor treatment adherence in patients with chronic medical conditions which can, in turn, lead to adverse health consequences, poor quality of life, and patient dissatisfaction. Poor treatment adherence may be due to lack of sufficient patient education, time delays in delivery of care, lack of adequate healthcare coordination, or difficulty accessing various healthcare providers across a front desk which serves as a “healthcare bottle-neck”. Better efficiency in healthcare delivery, with greater connectivity through knowledgeable and trained peer volunteers and cheap cell-phones integrated by a smart telephone exchange may alleviate some of the care and communication burden faced by the healthcare system. Specifically, such community health education volunteers (“peer-buddies”) who are experienced in managing their disease condition may be able to impart knowledge and confidence to a recently diagnosed patient in a much more personalized manner than that of a group therapy session. An additional important advantage is the peer-buddy’s ability to relate to the patient in a manner consistent with their social, ethnic, and cultural believes without language barriers or differences that may stem from socioeconomic strata. We will use sleep apnea as an example condition to test the effect of a peer-buddy helper (combined with the universal availability of personal cell phones) on the problem of poor care coordination and treatment adherence to the “CPAP” treatment for sleep apnea. Sleep apnea is a very common condition that affects 7-12% of the US population and if left untreated can lead to poor health and even death through its effects on high blood pressure, heart disease, stroke, and motor vehicle accidents. Fortunately, CPAP therapy can lead to a 3-fold reduction in such consequences, but patient adherence to such CPAP treatment is generally poor. We have recently completed a small study that demonstrated improved usage of CPAP treatment by patients receiving help from a peer-buddy with excellent results. We propose to further enhance the “peer-buddy” community-volunteer concept in our proposed research by combining this with cell-phone technology and a telephone exchange that improves access to healthcare providers, technicians, and home care companies. We hope to show that active community participation by experienced “lay individuals” assisted by the universal availability of cheap cell-phones can improve the reach and effectiveness of our healthcare system in improving the health and well-being of our patients. If successful, such an innovative and community-based approach can be applied to other chronic medical conditions.
MSSS (Multi Site Sleep Study)
Chronic and Moderate Sleep Restriction in Older Long and Older Average Sleepers
Effect of Hypoxia on Peripheral Blood Cells
In patients with a medical condition called “sleep apnea” the collapse of the throat muscles during sleep causes low oxygen levels in their blood stream. Such low oxygen levels can cause heart disease and heart attacks. Currently, treatment of sleep apnea involves a face mask that delivers pressurized air, but, patients have difficulty adhering to such treatment. Currently, there is no medication treatment for sleep apnea. Our study, is being conducted to see whether blood cells that are treated with anti-oxidants can better tolerate low oxygen levels when while exposed to low oxygen levels in a test tube in the laboratory. Moreover, the diagnosis of sleep apnea requires expensive testing – sleep studies – that require patients to sleep overnight in the sleep laboratory with cumbersome wires and electrode applied to their bodies and scalp. A simple blood test that could diagnose the low oxygen count due to sleep apnea (that occurs in a repeated manner) could have huge cost savings and pose much greater convenience to patients than sleeping in a sleep laboratory. We propose to examine the white blood cells derived from the blood of patients with and without sleep apnea to identify the signature of chemicals (“ribonucleic acids”) measured in their white blood cells. We will perform such blood tests in patients with other lung disorders that could cause low oxygen count -- such as chronic obstructive pulmonary disease (including emphysema and chronic bronchitis), interstitial lung disease, and asthma in order to see if such a blood test can distinguish differences amongst various conditions that can cause low oxygen count.
Comparative-effectiveness of Johrei Therapy and CBT-I in Facilitating Sleep in ICU Survivors
The purpose of this project is to compare the effectiveness of Johrei therapy (JT) and Cognitive-behavioral Therapy for Insomnia (CBT-I) in the treatment of sleep disturbances in survivors of critical illness. Subjects will be recruited following discharge and followed for 6 weeks. All subjects will undergo objective measurements of sleep quality and duration at baseline and at 6 weeks. Objective measurements will be made by portable (home-based) polysomnography and actigraphy. Subjective measurements will be performed by sleep questionnaires: PSQI, Epworth sleepiness scale, sleep log, and Stanford Sleepiness Scale which will be performed at baseline, 2 and 6 weeks. Venous blood draw and urine collection for measuring circulating levels of cytokines and neurotransmitters will be made at baseline and 6 weeks.
Prevalence and Cognitive Impact of Sleep Disordered Breathing in Children with Congenital Heart Disease
This project will investigate the role of sleep disordered breathing (sleep apnea) in children with congenital heart disease. There are some data, as well as theoretical rationale, suggesting that the rate of sleep disordered breathing may be higher in children with congenital heart disease than in the normal population. Congenital heart disease and sleep disordered breathing have both been associated with specific impairments in cognition, which impact learning and memory. It is possible that by treating sleep disordered breathing in these children; they will demonstrate improvement in learning and memory.
In this project, children with congenital heart disease will be screened for sleep disordered breathing, as well as undergo a brief neuropsychologic evaluation. The screening for sleep disordered breathing will be performed using a home polysomnogram, which is a test that measures breathing while asleep. The brief neuropsychologic evaluation will consist of a brief IQ test, as well as a computerized assessment that will focus on memory and learning. Two brief surveys will also be completed by the child’s caregiver to assess cognition as well.
We anticipate that children with sleep disordered breathing will perform worse on the neuropsychologic evaluation compared to children with similar cardiac abnormalities who do not have sleep disordered breathing. Data from this project will then be used to develop a future intervention study that will attempt to mitigate the cognitive impairment caused by sleep apnea in this population
A Pilot, Multi-Center, Randomized, Open-Label, Parallel Group Study to Assess the Effects of a Novel Application of Averaged Volume Assured Pressure Support Ventilation (AVAPS-AE) therapy on Re-hospitalization in Patients with Sleep-Disordered Breathing with co-morbid COPD. (STOP-BOUNCEBACK study)
Patients with emphysema or chronic bronchitis which are collectively called “COPD” are more likely to be admitted to the hospital for breathing difficulties and are also very likely to suffer from obstructive sleep apnea (OSA) a condition wherein they have repeated obstruction of their breathing when they sleep. The 30-day readmission rate for re-hospitalization of COPD patients is very high. There are studies that suggest that positive airway pressure (PAP) therapy which is applied by a home device with a face mask during sleep can reduce hospitalizations. Currently, in the US, we don’t screen patients for the OSA condition when they are in the hospital. Also, there are no well-done research studies that have compared patients being discharged from the hospital who receive PAP treatment versus not receive such treatment in order to assess the effect of PAP treatment on hospital readmissions in individuals with both COPD and OSA. We plan on doing such a study. This initial pilot study, if promising, could lead to a larger more definitive study that would yield meaningful results that could favorably affect how COPD patients are being managed in the hospital.
Servo-Ventilation In-lab PSG Evaluation
Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) is a condition where the upper airway partially collapses and closes. This can lead to sleep problems including low oxygen levels, poor sleep, elevated carbon dioxide levels in the blood, and activation of the sympathetic nervous system. Results from having disrupted sleep may be excessive daytime sleepiness along with behavioral, functional, cardiovascular and cognitive dysfunction. Continuous Positive Airway Pressure (CPAP) is the most effective treatment for OSAHS. CPAP stabilizes the airway and prevents instability and collapse. Other forms of positive airway pressure that are approved for the treatment of OSAHS include automatically adjusting CPAP, Bi-level Positive Airway Pressure (BiPAP), and automatically adjusting BiPAP. Automatically adjusting CPAP (Auto CPAP) evaluates the airflow pattern and adjusts pressure to optimize airflow. Auto SV (Auto Servo Ventilation) is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea. The purpose of this study is to verify the performance of these servo ventilation devices to see if any modifications need to be made to better treat OSAHS.
Non-inferiority Study of Telemedicine vs. Conventional CBT-I in Recently Hospitalized Patients with Insomnia
Insomnia is a common and distressing medical condition and persistent (or chronic) insomnia affects nearly 10-15% of U.S. adults 1. In an ongoing study of cognitive behavioral therapy for insomnia (CBT-I) in recently hospitalized patients, we found a high prevalence of insomnia (80%). Recently hospitalized patients who are recuperating in their homes would find it difficult to return for weekly visits with a clinical psychologist and therefore could benefit from the convenience of CBT-I treatment administered in the comfort of their homes via the wireless iPAD and video chat software. The AASM SleepTM platform could conceivably allow performance of CBT-I. In patients who are recently discharged from the hospital, we wish to assess whether telemedicine-based CBT-I is comparable to conventional office-based CBT-I in the efficacy for treating insomnia. In the future, our program of research aims to improve our understanding of whether insomnia represents a modifiable risk factor for re-hospitalizations in patients who are high utilizers of healthcare services.
Peer-Driven Intervention as an Alternative Model of Care Delivery and Coordination for Sleep Apnea
Fragmentation of care can lead to poor treatment adherence in patients with chronic medical conditions which can, in turn, lead to adverse health consequences, poor quality of life, and patient dissatisfaction. Poor treatment adherence may be due to lack of sufficient patient education, time delays in delivery of care, lack of adequate healthcare coordination, or difficulty accessing various healthcare providers across a front desk which serves as a “healthcare bottle-neck”. Better efficiency in healthcare delivery, with greater connectivity through knowledgeable and trained peer volunteers and cheap cell-phones integrated by a smart telephone exchange may alleviate some of the care and communication burden faced by the healthcare system. Specifically, such community health education volunteers (“peer-buddies”) who are experienced in managing their disease condition may be able to impart knowledge and confidence to a recently diagnosed patient in a much more personalized manner than that of a group therapy session. An additional important advantage is the peer-buddy’s ability to relate to the patient in a manner consistent with their social, ethnic, and cultural believes without language barriers or differences that may stem from socioeconomic strata. We will use sleep apnea as an example condition to test the effect of a peer-buddy helper (combined with the universal availability of personal cell phones) on the problem of poor care coordination and treatment adherence to the “CPAP” treatment for sleep apnea. Sleep apnea is a very common condition that affects 7-12% of the US population and if left untreated can lead to poor health and even death through its effects on high blood pressure, heart disease, stroke, and motor vehicle accidents. Fortunately, CPAP therapy can lead to a 3-fold reduction in such consequences, but patient adherence to such CPAP treatment is generally poor. We have recently completed a small study that demonstrated improved usage of CPAP treatment by patients receiving help from a peer-buddy with excellent results. We propose to further enhance the “peer-buddy” community-volunteer concept in our proposed research by combining this with cell-phone technology and a telephone exchange that improves access to healthcare providers, technicians, and home care companies. We hope to show that active community participation by experienced “lay individuals” assisted by the universal availability of cheap cell-phones can improve the reach and effectiveness of our healthcare system in improving the health and well-being of our patients. If successful, such an innovative and community-based approach can be applied to other chronic medical conditions.
SLEEP2
Strategically Leverage Engage and Empower PCOR in Sleep
CHARTS
Cardiovascular and Metabolic Functioning in Habitual Short Sleepers Fregosi: Testing the Efficacy of Tongue Muscle Training as a Non-invasive Approach for the Treatment of Obstructive Sleep Apnea Family Treatment: Family Treatment Preferences for Children with Obstructive Sleep Apnea
Sleep Intervention During Acute Lung Injury
Critically ill patients with serious lung disorders, who are on assisted breathing ventilators in intensive care units, can have poor sleep despite being on sedatives. Having sleep disrupted in the ICU may stimulate a patient’s sympathetic nervous, which in turn can increase inflammatory cytokines. This can lead to patient delirium and post-traumatic stress disorder, due to the consolidation of unpleasant memories during awakenings form sleep. Currently, there is little understanding of the relationship between critical illness, sleep, and psychological well-being, since there have been few studies examining treatments that influence sleep during critical illness. The central purpose of this study is to examine the short-term effects of sedation that reduces the activity of the sympathetic nervous system, on sleep and inflammation in critically ill patients with acute lung injury and acute respiratory distress syndrome (ALI/ARDS). Sedation will be achieved with an FDA approved sleep-promoting agent, Dexmedetomidine. This sedative has been shown to decrease delirium and decrease duration of mechanical ventilation and ICI stay in critically ill patients receiving mechanical ventilation. We will undertake sleep studies and measure circulating inflammatory cytokines in patients with ALI/ARDS randomized to receive either Dexmedetomidine or Midazolam in a randomized, double blind, cross-over study. Midazolam is a sedative that is traditionally used in the ICU, and produces sedation by a different mechanism than Dexmedetomidine.
- Specific Aim 1: To assess the short-term effect a sedative that inhibits the sympathetic nervous system on sleep quality in critically ill patients with ALI/ARDS.
- Specific Aim 2: To assess the short-term effect of a sympathetic nervous system inhibiting sedative on sleep-modulating inflammatory cytokines in critically ill patients with ALI/ARDS.
- Specific Aim 3: To determine the effect of such a sedative on the production of sleep-modulating inflammatory cytokines by blood mononuclear cells of patients with ALI/ARDS.
Our study will examine whether sleep disruption in these critically ill patients can be minimized. This research will identify sedation practices that are least associated with adverse short- and long-term consequences of critical illness, thereby helping to improve quality of life of patients surviving critical illness.
AVAPS
Randomized Controlled Trial Evaluating the Feasibility of AVAPS-AE vs. CPAP vs. Bi-level Pressure Support Ventilation in Obesity Hypoventilation Syndrome