View clinical trials related to Sleep Apnea, Obstructive.
Filter by:This study has been developed in order to demonstrate the validity of the DreamKit respiratory effort signal.
Continuous positive airway pressure (CPAP) is the first-line treatment for obstructive sleep apnea syndrome (OSA). It consists of a pressure generator connected to a mask applied to the patient's face. CPAP treatment is restrictive, and nearly a quarter of patients abandon it over the long term. Various factors can influence adherence to CPAP therapy, including adverse events associated with the mask. However, it is clear that compliance with CPAP treatment, even if it has tended to improve over the last 30 years, is still sub-optimal. The "Air Liquide Medical Systems" company has developed a mask that aims to improve comfort and ease of use for the patient. This leaky nasal mask has a "silent" intentional leak port, which significantly reduces the noise caused by the escape of air. The noise associated with intentional leakage is one of the discomforts reported by patients and their spouses. In addition, this mask is equipped with a new generation headgear with adjustment indicators to assist the patient in fitting the mask. Optimal headgear fit is a prerequisite for comfort during treatment, as it reduces unintentional leakage. The main objective is to evaluate, through a questionnaire, the comfort and general appreciation of a nasal mask equipped with a silent leak system and a headgear with adjustment aids, of patients with OSA treated with CPAP. Secondary objectives are : 1. To evaluate the appearance of CPAP side effects related to the mask, 2. To collect the patient's appreciation of the mask headgear, 3. To evaluate the discomfort caused by the nasal obstruction reported by the patient, 4. To evaluate the daytime sleepiness of the patient, 5. To study the parameters of the CPAP treatment.
Compliance of continuous positive airway pressure （CPAP） derived from auto-titration is similar to that derived from manual titration, although pressure derived from the former was usually 2-5 cmH2O higher than the latter. Therefore the Investigators hypothesize that accurate titration maybe not necessary for successful treatment of obstructive sleep apnea (OSA) as long as CPAP pressure was not lower than the minimal effective pressure.
Overnight rostral fluid shift is one of the contributing factors for worsening obstructive sleep apnoea (OSA). Fluid shift has been recognized to play a role in the pathophysiology of sleep apnoea. Previous studies shown that fluid from the leg redistributes to the neck at night increases the neck circumference, hence indicating fluid accumulation in the neck. OSA patients are more susceptible to developing upper airway narrowing in response to fluid shift from the leg to the head and neck region. Previous studies were mainly done on Caucasian patients. The pathophysiology of OSA in Caucasian patients and Asian patients are different but both suffer a similar degree of OSA. The investigators would like to investigate if reducing leg swelling by a simple non-invasive intervention of wearing compression stocking during the day can attenuate sleep apnoea, and whether compression stocking is generally acceptable and well-tolerated among the general OSA population in Asia.
This is a prospective, open-label study to evaluate the effectiveness of providing a dashboard with merged health metrics of CPAP (continuous positive airway pressure/ PAP) usage, self-reported sleepiness, blood pressure (BP) and activity (steps).
Obstructive sleep apnea-hypopnea syndrome (OSAHS) is characterized by the occurrence of abnormally frequent episodes of interrupted ventilation (apnea) or significant reduction of ventilation (hypopnea) during sleep. It is linked to a repeated collapse of the upper airways during sleep. Episodes of apnea and hypopnea cause hypoxemia and micro-awakenings with a well-established impact on quality of life and daily activities. Physiologically, OSAHS can be aggravated when moving from a standing to a supine position through fluid shift from the lower limbs to the upper body, thereby modifying the opening of the upper airways. A decrease of the water balance by bilateral diurnal compression of the lower limbs (during daytime in standing position) may limit this nocturnal fluid shift (at night in supine position) and thus reduce the severity of OSAHS. Two comparative clinical trials [Redolfi 2011; White 2015] have shown a clinically modest reduction of sleep apnea (-36% and -27%, respectively), which was however statistically significant versus untreated control group (p = 0.002 and p = 0.04, respectively), when elastic compression medical devices of 20 to 30 mmHg were worn during the daytime. The hypothesis of fluid shift influence on OSAHS has been tested [Berg 1993; Redolfi 2011; White 2015], but the decrease of the water balance when the device is used remains to be quantified. The CVE101-15 exploratory clinical investigation sponsored by Laboratoires Innothera performed on healthy volunteers confirmed the hypothesis of a diuretic effect of elastic compression stockings applying a pressure of 33 mmHg at the ankle, worn for 13-14 hours during the daytime for 3 days, with a good safety profile of this device. Moreover, it enabled the identification of reliable parameters and the endpoints to be used to demonstrate a diuretic effect. Based on this information, there may be a real interest in conducting further investigations about the evolution of water balance beyond a 3-day period of elastic compression use in the daytime. Hence, the main objective of this clinical investigation is to compare precisely, under standardized test conditions, water balance changes in healthy subjects over 5 days with or without daytime use of the investigational medical device (IMD), an elastic compression device prototype specially designed for this study.
This is a randomized, double blind, 2-period, non placebo-controlled crossover study in patients with moderate to severe OSA and controlled hypertension, comparing atomoxetine with AD113
The conjunction of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) is known as Overlap Syndrome (OS). The coexistence of these diseases have cardiovascular morbidity and mortality. The aim of this study is to assess the prevalence of OSA in COPD patients. 100 COPD patients (obese and non-obese) performed sleep questionnaires and polysomnogram.
The objective of the study is to define an optimal threshold of the SEMSA-15 scale for obstructive sleep apnea (OSA) perception in patients with OSA to predict 3-month and 1-year continuous positive airway pressure adherence.
Breathing is one of the body's vital functions that occur under normal conditions using the nose. When humans breathe primarily through the mouth instead of the nose, this is referred to as mouth breathing. Snoring and obstructive sleep apnea (OSA) occur frequently in mouth breathers. Mouth breathing impairs oral health, reduces quantity and quality of saliva, and increases dry mouth, risk of developing dental caries, gingival inflammation, bad breath and dry lips. Serious health conditions associated with an obstructed upper airway in those who snore include hypertension, cardiovascular disease and mild cognitive impairment. Oral appliances (OAs) that bring the lower jaw (mandible) forward have been shown to be highly effective in reducing snoring and interruptions in breathing (respiratory events) that occur in those who snore and/or have OSA. The myTAP™ OA (AMI, Dallas, TX) includes an optional mouth shield (MS) that is anticipated to promote nasal breathing. The purpose of this study is to investigate the effects of oral appliance plus mouth shield therapy on sleep cardio-respiratory dynamics (breathing and heart activity) and their effect on improving OSA and oral health, especially of the periodontal tissues, in confirmed mouth breathers who snore and/or have OSA. As many as 70 adults at least 18 years old will be recruited to participate. All participants will wear the OA during sleep for 8 weeks (Phase 1). Half of the participants will be randomly assigned to wear the OA only for the first 4 weeks; all will wear both the OA and MS for the last 4 weeks. Participants will wear an easy-to-use home sleep recording system (NOX T3) for 2 nights at the start of the study and again at 4 weeks and 8 weeks. Based on the investigators' experience, some participants will not have achieved maximal benefit from the OA at 8 weeks, and will require addition adjustment. These participants will enter a second phase of the study where they will have 1 or more sleep studies done at 2 week intervals, and will further adjust their OAs (that is, advance the mandible) to eliminate snoring.