Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Resistant...
Resistant HypertensionObstructive Sleep ApneaThe objectives of this study are to investigate the effect of continuous positive airway pressure (CPAP) treatment on blood pressure control and vascular inflammation in subjects with resistant hypertension and moderate obstructive sleep apnea (OSA).
Continuous Positive Airway Pressure and Acetazolamide to Treat Sleep Apnea Syndrome Patients at...
Obstructive Sleep Apnea SyndromeThe purpose of the study is to investigate the effect of nasal continuous positive airway pressure in combination with acetazolamide as a treatment for sleep related breathing disturbances in patients with the obstructive sleep apnea syndrome living at low altitude during a sojourn at moderate altitude.
Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort...
Sleep ApneaThe purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.
Study of Provent Treatment of Obstructive Sleep Apnea in Patients Who Are Non-compliant With CPAP...
Sleep ApneaObstructiveThe primary objective of the proposed investigation is to evaluate the efficacy of the Provent device in a sample of OSA patients who have either refused or been non-adherent with PAP treatment. Both initial efficacy (evaluated after approximately one week with Provent) and efficacy after approximately 5 weeks in patients who demonstrate initial efficacy will be assessed. A secondary objective is to assess adherence with Provent treatment during the 5-week evaluation period.
Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic...
Sleep Disordered BreathingCheyne-Stokes Respiration1 moreThe purpose of this feasibility study is to determine the effect of stimulating the phrenic nerve to treat periodic breathing (a pattern of breathing characterized by hyperpneas followed by hypopneas or apneas). Clinically, these physiologic events translate into sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly ventricular arrhythmias. Stage 1 of the study is acute in nature, such that subjects will undergo the placement of a stimulation lead, followed by assessment of stimulation of the phrenic nerve using the lead for up to 2 nights of sleep. A sensing lead may also be placed during the initial implant procedure. Observational data will be obtained and stimulation provided using an externalized system connected to the study leads. Following the study, all investigational components will be removed from the patient. Stage 2 of the study is being conducted at one of the participating sites to determine the initial safety of chronic stimulation of the phrenic nerve in a limited number of patients with sleep disordered breathing. It is anticipated that data obtained in this feasibility study will show that the proposed intervention can modify respiration with a low incidence of adverse effects. The results of this trial are intended to be used to develop a subsequent protocol for a multi-center study of chronic phrenic nerve pacing.
Effects of Obstructive Sleep Apnea Treatment by Fixed CPAP and by Auto-CPAP (Somnosmart2)
Obstructive Sleep Apnea SyndromeThe main purpose of this study is to investigate if treatment of obstructive sleep apnea syndrome (OSAS) by continuous positive airway pressure (CPAP) given by a traditional CPAP device administering a fixed air pressure, or by one automatic CPAP device ("Somnosmart2", Weinmann, Hamburg) administering variable pressures, have different effects on sympathetic nervous system tone (as reflected by urinary excretion of norepinephrine and its catabolite normetanephrine) and on blood pressure.
Nasal Decongestion and Obstructive Sleep Apnea
Obstructive Sleep Apnea SyndromeRhinitisWhether impaired nasal breathing contributes to sleep related breathing disturbances has not been known. Therefore, the purpose of the study is to compare the effect of xylometazoline, a drug that decongests the nasal mucosa when applied locally, with placebo in terms of sleep and nocturnal breathing and daytime performance.
An Investigation to Test the Efficacy of the High Flow (HF) Continuous Positive Airway Pressure...
Obstructive Sleep ApneaPhase One: High Flow (HF) CPAP (HF-CPAP) Titration: Participants will attend the sleep lab to undergo a comprehensive split-night respiratory PSG. Each participant will be randomized to one of 20 L/min or 35 L/min of CPAP for the first half of the night and swapped to the alternate flow rate for the second half o the night. At the completion of night 3 participants will be categorized as responders or non-responders. Only responders will continue to Phase 2 of the investigation. Phase Two: HF-CPAP compared with CPAP: Participants will attend the sleep lab to undergo a comprehensive overnight respiratory PSG. Each participant will be randomized to HF-CPAP at a flow rate of 35 L/min or to conventional CPAP at their therapeutic pressure. They will spend the entire night on this treatment arm. Thew following night participants will undergo the alternative treatment arm for the duration of the night.
Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device...
Sleep Disordered BreathingSleep Apnea1 moreThis study is being undertaken to collect data from Respironics Inc's BiPAP Auto Servo Ventilation 3 (autoSV3) and compare with data from Respironics, Inc's BiPAP autoSV2, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Complex Sleep Apneas (Comp SAS) no worse than its predecessor, the BiPAP auto Servo ventilation 2 (autoSV2) device. This will be determined using a comparative, randomized design with the participants blinded to the therapy. Additionally, attempts will be made to blind the central scorer(s) with respect to which device is in use.
Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea
Obstructive Sleep Apnea HypopneaOSA1 morePrimary Endpoints: •Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine) Secondary Endpoints: By polysomnography, reduction in: AHI with device on vs. off at 3 months, controlling for sleep position Oxygen desaturation index with device on vs. off Arousal index with device on vs. off Duration of snoring with device on vs. off Epworth Sleepiness Scale Patient acceptance, in terms of: Refusal rate at screening Discontinuation rate during follow-up Daily compliance rate Device-related adverse events Serious adverse events