View clinical trials related to Sleep Apnea Syndromes.
Filter by:Stillbirth (SB) is a devastating complication of pregnancy and contributes to over 2 million deaths globally every year. Over 20 million infants are born every year with low birth weight (LBW), which is associated with a twenty times increased risk of death in the first year of life and high rates of short- and long-term illnesses. Sleeping on one's back during pregnancy has recently emerged as a potential risk factor for LBW and SB in the medical literature. In high-income countries, SB rates have mostly remained the same in the past two decades and targeting modifiable risk factors could help reduce the number of SB and LBW in the population. When a pregnant woman sleeps on her back, her body position compresses underlying blood vessels and reduces blood flow to the developing baby. This body position could cause unpleasant symptoms for the mother and result in LBW or SB of her baby. Lying on her side or with a slight lateral tilt helps relieve this compression. One way to keep people off their back while sleeping is by using positional therapy (PT). It is a simple, safe, inexpensive and effective intervention for preventing people who snore or people who's breathing pauses during sleep from sleeping on their back. Reducing the amount of time pregnant women sleep on their back could help reduce SB and LBW rates. The investigators developed a PT device (PrenaBelt) and tested it in three clinical trials, which demonstrated that it significantly decreases the number of time women spend sleeping on their back. Using feedback from our previous research, the investigators developed five additional devices that will be tested in this study. The purpose of this study is to evaluate the new PrenaBelt (PB2) prototypes' ability to reduce the amount of time pregnant women sleep on their backs in the third trimester of pregnancy, validate the Ajuvia Sleep Monitor, and collect feedback on the devices. Demonstrating that the sleeping position of pregnant women can be modified through the use of a simple, inexpensive PT intervention may be one of the keys to achieving significant reductions in LBW and late SB rates in Australia and worldwide.
An observational clinical trial in a single centre. The objective of this study was to determine the efficacy of mandibular advancement device (MAD) therapy on snoring intensity, frequency, and oxygen desaturation periods in mild-moderate obstructive sleep apnea (OSA) patients with snoring problems. Totally, 18 mild-moderate OSA patients (8 females and 10 males) with subjective snoring complaint were selected. Each patient's diagnostic polysomnographic analysis (PSG) was accepted as initial PSG values. Each patient was subjected simple pulse oximeter (SPO) and smartphone sleep application (SSA) at 3 different nights at home. Diagnostic mean values of oxygen desaturation index (obtained by using SPO), snoring intensity score (obtained by using SSA), and snoring percentage (obtained by using SSA) were recorded. Non-titratable-customized MAD with 60-75% of maximal mandibular protrusion were fabricated. The patients were instructed to wear their MAD every night. SPO and SSA measurement were repeated at the 1st, 4th, 12th, and 24th week of the treatment process. At the 24th week of treatment, The PSG were repeated and all PSG, SPO, and SSA values were compared with initial diagnostic values.
The proposed study is a randomized cross over trial assessing the efficacy of two different positional therapies for positional obstructive sleep apnea (POSA). The effectiveness of the two different therapeutic devices (Positional pillow and vibrating belt) in reducing the time spent sleeping supine, and therefore at risk of apnoeas, will be evaluated consecutively in 52 subjects with a de novo diagnosis of positional sleep apnoea. The subjective quality of sleep will also be evaluated prior to treatment and following the use of each separate device by means of a "Quality of sleep questionnaire"
The Obstructive Sleep Apnea is characterized by obstruction of the upper airway during sleep (for at least 10 sec), with repeated breathing pauses, accompanied by oxygen desaturation in the blood and by sleep interruption with repeated arousals. The investigators hypothesized that good sleep hygiene, the execution of respiratory rehabilitation exercises, with specific myofascial exercises on the muscles that are compromised in the Obstructive Sleep Apnea, can improve the patient's clinical outcome and quality of life. The objective of this study is to evaluate the effect of respiratory rehabilitation with myo-functional exercises in mild obstructive sleep.
Evaluation of residual sleep disordered breathing (SDB) under continuous positive airway pressure (CPAP) therapy with comparison of the automatic detected SDB event indices from CPAP machines with manual scored polysomnography (PSG).
This prospective cohort study aims to compare the proportion of cardiac or cerebrovascular events after a first stroke, a first transient ischemic attack (TIA) or recurrent TIA, between sleep-disordered breathing (SDB) and non-SDB (control) patients, one year after SDB diagnosis, performed 3 months after stroke onset. The primary outcome is a composite endpoint composed of cardiac or cerebrovascular events regrouping: death from any cardiac or cerebrovascular cause, non-fatal stroke, and non-fatal acute coronary disease. 1620 patients, in the acute phase of a first stroke, TIA or recurrent TIA will be included in the cohort. Clinical, neuroimaging, sensorimotor, cognitive and biological parameters will be collected at inclusion. Three months after stroke or TIA onset, polysomnography will be performed for SDB diagnosis. Patients will be considered as having SDB for an Apnea-Hypopnea Index (AHI) > 15 events/hour, or to the control group otherwise. The same clinical, imaging, cognitive and biological assessments than during the first visit will be performed; incident (new) cardiovascular events will be collected. Three months later, and at 1, 2, 3, 4 and 5 years after SDB diagnosis, the same clinical, cognitive, sensorimotor, and sleep-related evaluations will be performed. In addition to the aforementioned parameters, incident cardiovascular outcomes will be collected, at the same time points. The primary study outcome will be retrieved one year after stroke onset.
This study evaluates the combination of two drugs (AD128), to treat obstructive sleep apnea (OSA) severity. After a baseline evaluation and during 7 days, half of the participants will randomly receive this drug combination (AD128) and the other will receive a placebo, i.e. a drug without pharmaceutical effect. Neither the participants, nor the investigators will know in which arm participants are until the end of the study. After one week of trial, an evaluation will be perform and will be follow by one week without any treatment. During the third and last week of trial, there will be a crossover of the groups, i.e. the participants of the first group who took the two drugs (AD128) during the first week will take a placebo and those who took the placebo will take the drugs combination.
It has been shown that a common cause for snoring and throat obstruction (obstructive sleep apnoea (OSA)) is excessive loss of muscle tone in the throat when the investigators go to sleep. This results in the partial collapse of the throat (snoring) or complete collapse (OSA) during sleep. 45% of the male population snore. Sleep apnoea affects 4 to 6% of the population and is associated with increased incidence of raised blood pressure, heart attacks and strokes. Although there are several lifestyle practices associated with snoring such as smoking, obesity and drinking, a significant proportion of people may snore despite not being associated with these. A solution to this issue is to improve the muscle tone of the throat so that it doesn't collapse so easily. Several studies have shown that certain types of throat exercises can help reduce snoring. Further studies have also shown that using electrical stimulation to exercise the tongue muscles has the same effect. From this, doctors in the United Kingdom (UK) have developed a new type of device, eXciteOSA, that allows a more accurate and comfortable way of delivering this energy to exercise the tongue muscles. The device works by stimulating the tongue muscles during the day so that the tongue is less likely to collapse during sleep. It is a form of "workout" for the tongue and like other physical exercise regimes, it needs to be repeated regularly for a few weeks to take effect. The aim of this study is to see if the eXciteOSA device is as effective as the previous methods and if it can reduce snoring and improve sleep quality. This will be achieved by participants using the eXciteOSA once daily for a six week period. A two night sleep study with watchPAT along with a polysomnography will be completed before and after the therapy to compare results. Questionnaires on sleep quality and quality of life will also be completed pre and post therapy.
Obstructive Sleep apnea carries a variety of complications and implications. While the disease could be treated using continuous positive airway pressure (CPAP) and lifestyle changes, many patients find it difficult to adjust to the mask, and turn to surgical options. The conventional surgical options to date ranges from radical (UPPP) to individualized, with or without Drug-induced sleep endoscopy (DISE). Previous studies showed that dise directed surgery can be useful for specific conditions. No trials were found to test in-office encompassing minimal invasive surgical treatment (RF palatoplasty , RF tonsillotomy, RF turbinectomy, and RF base-of-tongue reduction) as a viable alternative..
The aim of this study was to compare an overnight digital monitoring device (ODM) with home sleep apnea testing (HSAT) using respiratory flow and effort parameters in a large population sample, who were in a waiting list for Polysomnography (PSG).