View clinical trials related to Sleep Disordered Breathing.
Filter by:Sleep disordered breathing (SDB) insidiously worsens metabolic function, heightens insulin resistance (IR), and in pregnancy is thought to precipitate gestational diabetes, preterm birth, growth restriction, gestational hypertension, and preeclampsia. Despite the fact that sleep disturbances are common during pregnancy, SDB remains under-recognized, under-diagnosed, and poorly understood, particularly in pregnancies affected by obesity. Sixty percent of pregnancies are now affected by obesity, yet the relationship between SDB, patterns of glycemia, and insulin resistance (IR) in obese pregnant women is a neglected area with major therapeutic implications to improve maternal and infant health. Using a prospective design in which diet and gestational age are highly controlled, the investigators propose to measure SDB (apneas/hypopneas) in obese pregnant women using an ambulatory sleep monitoring system. In parallel, robust patterns of glycemia will be measured with a continuous glucose monitoring system (CGMS), followed by a 75g oral glucose tolerance test to measure insulin action. The investigators global hypothesis is that worse SDB in part accounts for higher 24-hour patterns of glycemia in obese normal glucose tolerant (NGT) pregnant women in their 3rd trimester. The Investigators will test the hypothesis that: 1) In obese NGT pregnant women at 32-34 weeks gestation on a controlled eucaloric diet, higher apnea hypopnea index (AHI) will be positively associated with 24-hour glycemia measured by a CGMS and that, 2) Higher AHI in obese NGT pregnant women at 32-34 weeks gestation on a eucaloric controlled diet will be associated with higher insulin resistance measured by a 75g oral glucose tolerance test (Matsuda Model). Early identification and treatment has the potential to decrease long-term maternal cardiovascular morbidity and mortality.
This study aims to determine the prevalence and prognosis of heart failure with preserved ejection function (HFpEF) among patients being assessed for sleep disordered breathing (SDB).
Obstructive sleep apnea (OSA) is a common disease that is largely un-diagnosed and untreated. Standard treatment for obstructive sleep apnea, nasal continuous positive airway pressure (CPAP), entails use of a nose mask to deliver positive pressure which dilates the pharynx and eliminates obstruction. This therapy is highly efficacious and benign but is associated with low adherence, particularly in non-sleepy apneics with disease of mild and moderate severity. The principal alternative to CPAP therapy is oral appliance (OA) therapy in which a custom made mandibular advancement splint (MAS) is used to protrude the mandible during sleep, thereby opening the pharyngeal airway. OA therapy, while preferred and well accepted by most participants, is not uniformly efficacious. Additionally, uncertainty regarding the patient's response to OAT and the effective target mandibular position can lead to a significant time span between diagnosis and initiation of effective treatment. Furthermore, knowledge of the effective target mandibular position supports the use of new OA design and manufacturing processes that can further reduce the time and cost in delivering the therapy. Zephyr Sleep Technologies (the Sponsor) has developed a method of identifying OAT responsive participants and their efficacious mandibular protrusion. Recently, Zephyr Sleep Technologies developed a portable device that avoids this requirement and can be used in a multi-night test in the home. Using a feedback controlled mandibular positioner (FCMP), the device measures and analyzes respiratory airflow and oxygen saturation and makes decisions in real-time about moving the mandible. The FCMP device was tested in a blinded, bi-phase clinical study in which participants with mild-to-severe sleep apnea (n=202) underwent two full-night studies in the home. Data from phase 1 were used to develop a predictive method, and data from phase 2 were used to prospectively test the accuracy of the predictive method. An efficacious mandibular position was also predicted, and each participant was treated with a custom oral appliance set to that position. Data from both phases were used to evaluate the feasibility of use of the device in the home. A random forest machine learning system was used to develop and test the predictive method. The overall oral appliance success rate was 76% for phase 1 and 71% for phase 2. The overall predictive accuracy was 88%. Values for sensitivity and specificity were 85% and 93%, respectively. Positive and negative predictive values were 97% and 72%, respectively. The effective target protrusive position was identified in 86% of cases. The studies were conducted independently by the participants in their homes, though due to limitations in the early prototype design, a clinical coordinator visited the home to set up the equipment prior to each night of study. No significant problems were encountered, and no significant risks were identified. The results of the clinical trial show that the auto-titrating mandibular positioner is suitable for use in the home and accurately predicts OAT outcome as well as target protrusive position. Based on the results of this study, Zephyr developed a commercially available device which has been approved for sale in Canada (Health Canada device license #97614). The device, branded MATRx plus, functions as both a sleep recorder as well as a home-based system to select patients for oral appliance therapy. This commercially available device is currently being used in three separate usability trials to quantify the usability of the device and the benefits of an improved workflow through adoption of the new technology in a dental practice. Evidence has recently appeared to indicate that the change in pharyngeal volume caused by protrusion of the mandible, measured while awake, correlates with the change in apnea-hypopnea index (AHI) achieved by OAT, measured while asleep. This is the first convincing evidence that an awake measurement of the pharyngeal airway correlates with the improvement in respiratory status during sleep induced by an oral appliance. The implication is that a simple conebeam CT of the pharynx can predict outcome with OAT. Accordingly, we shall carry out conebeam CTs in the research protocol, both at rest position of the mandible and at 90% of maximal protrusion. The purpose of this study is to test whether the predictive accuracy of the FCMP in the home environment is improved by the commercial design and whether patients predicted to be suitable for oral appliance therapy have long term adherence.
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.
To characterize the performance of the nasal dilator strip in lowering nasal resistance during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep disordered breathing in a group of chronic nocturnal nasal congestion sufferers who report trouble with their sleep.
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the seal/mask.
This investigation is designed to evaluate the performance (treatment and leak), comfort (subjective feedback), stability (subjective feedback, leak) as well as the participant's overall acceptance of the Saturn mask amongst OSA participants. An important factor in this investigation will be the testing of our two different seal sizes on the participants (small and medium size). A total number of 15 participants who currently use nasal or nasal pillow masks will be recruited for the trial. A subset of participants have been selected based on their anthropometric measurements collected in previous trials using nasal and nasal pillow masks at this site (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited by WellSleep, Wellington. Participants will use the trial mask in home for a period of 7 ± 3 days. Baseline data will be collected from the participant during the first visit, the prior 7 days of CPAP usage data will be downloaded and stored for our analysis. The participant will use the trial device on their usual CPAP/APAP setting and device for the duration of the trial. This study will be conducted in accordance with ICH/GCP guidelines. No deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor as soon as possible.
There is evidence for a high prevalence of Sleep Disorder Breathing (SDB) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Central Sleep Apnea, Cheyne-Stokes Breathing and Obstructive Sleep Apnea appear to occur in CTEPH. However, there is no information on the impact of CTEPH treatment modalities on concomitant SDB. Furthermore, the use of PAP therapy in CTEPH has not yet been investigated. CTEPH is a rare and serious disease and there may be a bidirectional association of SDB and CTEPH. This study plans to investigate the prevalence of SDB in CTEPH and compare it to datasets of large epidemiological studies on SDB. Furthermore, the impact of CTEPH treatment on SDB will be analyzed and CTEPH patients for possible PAP treatment will be defined.
The objective of this trial is to determine whether an opioid-free general anesthetic (OFA) technique utilizing ketamine, dexmedetomidine, lidocaine, and gabapentin can help reduce postoperative respiratory depression in the post-anesthesia care unit and ward in children with sleep-disordered breathing undergoing tonsillectomy when compared with traditional opioid-containing techniques. It is expected that this OFA regimen will have a measurable reduction on postoperative respiratory depression in children with sleep-disordered breathing.
Sleep disorder breathing (SDB) is a condition affecting 10% of children aged 2-6 years. It is a combination of snoring most nights during sleep, patchy sleep, short periods of stopping breathing (apnoea) and usually big tonsils. Most of these children get better with no treatment by 8 years old. It has been suggested that having SDB mean that some children concentrate and behave less well during the day and may learn more slowly than children who don't snore. It has become common for many Ear, Nose and Throat (ENT) surgeons to take out tonsils and adenoids (adenotonsillectomy) for this condition. Removing the tonsils and adenoids (which are normally big at this age) means that most children quickly stop snoring and seem to be cured. Unfortunately it is not clear if this operation makes any difference to learning compared to just watching the child and letting them "grow out" of the condition (watchful waiting). There is no set treatment in the UK today. Children may be offered adenotonsillectomy or watchful waiting; it is not know which, long term, is the right thing to do. Therefore the investigators wish to do a study looking at these two different treatments to see if there is a difference in children's learning over time between the two different treatments. The investigators will look at children with SDB, measure their learning (and behaviour) and then randomly select which children get one treatment or the other. They will then re-measure learning (and behaviour) 7 months later to see if there is any difference between the two groups. The investigators will also scientifically measure their sleep. This is possibly quite a difficult study to do, the investigators are unsure whether families will agree to take part and how easy it will be to measure learning with such young children (aged 2:6 - 5).