Metabolic Study of Sleep Apnea in Men and Women
Obstructive Sleep Apnea (OSA)The purpose of this study is to look at the metabolic (use of energy) and hormonal features of sleep problems in men and women.
Investigation of a Novel Positive Pressure Therapy to Rescue Patients Failing to Tolerate CPAP During...
Obstructive Sleep ApneaThe primary objective outcome is the proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the investigation. Proportion will be calculated using the cumulative number of hours on therapy divided by the total number of days of the investigation for each participant. The mean and standard deviation of these mean therapy hours will then be calculated for each arm of the investigation. Participants with compliance of at least four hours will be classified as "compliant" and those with less than four hours will be classified as "non-compliant". The null hypothesis will be rejected if the mean of the primary objective outcome for all participants in the BiPAP® Auto with Bi-Flex® therapy arm is significantly greater than that for all participants in the CPAP therapy arm. Secondary Measures The secondary measures used to evaluate potentially improved adherence to BiPAP® Auto with Bi-Flex® therapy compared to CPAP therapy will include: Hours of use per night, for all nights Hours of use per night, for nights with therapy use Device derived AHI Heart Rate Variability Functional Outcomes of Sleep Questionnaire (FOSQ), 10 cm Visual Analog Scale (VAS) for mask comfort and satisfaction with therapy, Epworth Sleepiness Scale (ESS) questionnaire Psychomotor Vigilance Task Attitudes toward use Actigraphy (sleep continuity) and sleep diary Fatigue Severity Scale Daytime Functioning Scale
Positive Pressure Treatment of Obstructive Sleep Apnea
Obstructive Sleep ApneaSix month at home positive pressure therapy study; which mode of therapy will lead to better adherence and patient outcomes?
Safety of Ramelteon in Subjects With Mild to Moderate Obstructive Sleep Apnea
Sleep ApneaObstructiveThe purpose of this study is to assess the safety of ramelteon, once daily (QD), in individuals with obstructive sleep apnea.
The Role of Sleep Apnea in the Acute Exacerbation of Heart Failure
Heart FailureObstructive Sleep Apnea2 moreThis study will evaluate whether treating sleep apnea while in the hospital would help heart failure, and assist recovery from the worsening of the heart function more than the current clinical standard of waiting for treatment until the subject have left the hospital. Heart failure affects more than 2% of the US population and is the only cardiovascular disorder with rising incidence. The annual cost of CHF in 2005 was $ 27.9 billion, large percentage of which is the cost of hospitalizations for exacerbation of CHF. Half of patients with CHF have some form of sleep apnea, and most of them go undiagnosed. Patients with CHF and OSA benefit from treatment with CPAP as an outpatient. The society can benefit from developing recommendations for approaching sleep apnea in the hospitalized CHF patient, which may shorten length of stay, improve functional status of discharged patient, and reduce rehospitalizations.
Nasal Budesonide in Children With Rhinitis and/or Mild Obstructive Sleep Apnea Syndrome
Obstructive Sleep Apnea-Intranasal budesonide therapy may lead to improved symptoms and sleep study findings in children with mild obstructive sleep apnea with and without allergic rhinitis that would not be treated with T&A. The aim of the study is to conduct a randomized double blind cross-over trial comparing the effect of once a day intranasal budesonide therapy vs. placebo in children with mild sleep apnea that would not be candidates for T&A.
Evaluation of Adherence and Therapeutic Effectiveness of Bi-Flex Versus CPAP in Children With OSA...
Obstructive Sleep ApneaContext: The obstructive sleep apnea syndrome (OSAS), i.e., snoring with difficulty breathing during sleep, is common in children. Continuous positive airway pressure (CPAP) therapy is the usual treatment for children who do not improve following surgery. However, CPAP is uncomfortable and is often not tolerated. We therefore plan to study a modification of bilevel positive airway pressure therapy, BiPAP with Bi-Flex that may be more comfortable. Objectives: The primary objective of this study is to determine whether BiPAP with Bi-Flex results in improvement in adherence as compared to CPAP. The secondary objective is to determine whether Bi-Flex has similar therapeutic efficacy compared to CPAP, as determined by sleep study. Additional objectives include comparing CPAP and Bi-Flex effects on comfort and determining which parameters predict adherence. Study Design/Setting/Participants: A single center, randomized controlled double-blind study of Bi-Flex vs CPAP use in children with OSAS over a 3 month period. Intervention: Bi-Flex vs CPAP Study Measures: Objective compliance recordings, sleep study results, subjective questionnaire results. .
Down Syndrome and Continuous Positive Pressure Therapy
Down SyndromeObstructive Sleep Apnea SyndromeThe purpose of this study is to evaluate the efficacy and tolerability of Continuous Positive Pressure for SAOS in Down Syndrome patients.
Tongue Advancement for Obstructive Sleep Apnea
Sleep ApneaObstructiveThe objective of this study is to assess the feasibility, safety and effectiveness of tongue stabilization using Aspire Medical Advance™ System for the treatment of obstructive sleep apnea (OSA). Success is defined as a statistically significant reduction in AHI measured by polysomnography (PSG) from baseline to 6 months.
Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea
Sleep ApneaObstructiveThe primary objective of this study is to assess the activity of 4 escalating doses of AVE0657 in comparison to placebo in patients with Obstructive Sleep Apnea Hypopnea Syndrome.