Active clinical trials for "Sleep Apnea Syndromes"

a monocentric,non interventional, prospective study to compare cardiovascular risk in patients with Obstructive Sleep Apnea/Hypopnea Syndrome treated with Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Orthosis.

Drug-induced sleep endoscopy (DISE) is the most used technique for identifying the obstruction site associated with obstructive sleep apnea (OSA). This is due to the fact that it allows many patients to be examined in a daytime setting. This procedure uses sedative drugs to mimic natural sleep. However, associations with the site of upper airway (UA) collapse during natural sleep remain unclear. The aim of this explorative study is to identify UA collapse in patients with OSA using endoscopic techniques as well as flow shape characteristics and sound analyses during natural and drug-induced sleep. Furthermore, we want to optimize the measurement set-up of natural sleep endoscopy (NSE).

Investigators hypothesize that in patients with obstructive sleep apnea (OSA) the severity of periodontal disease is significantly higher compared to patients without OSA in every aspect, including PI, PD, CAL and BOP. The number of lost teeth is hypothesized to be also higher in patients with obstructive sleep apnea. Purpose: evaluation of periodontal status in patients with obstructive sleep apnea. An analytical cross-sectional study will be conducted at the Department of Therapeutic Dentistry of the Sechenov University, Moscow. Investigators are planning to recruit 100 patients: 1) patients with OSA confirmed by polysomnography -75 participants aged between 35 and 65; 2) patients without OSA -25 participants of a similar age. Patients with obstructive sleep apnea syndrome will be sub-divided into three sub-groups according to OSA severity: 2A group - patients with mild apnea severity; 2B group - patients with medium apnea severity; 2C group - patients with severe apnea. All participants will undergo a dental examination including the following parameters: plaque index (PI; Silness & Loe, 1964), bleeding on probing (BOP), and touch depth of the pocket (PD), the level of clinical attachment loss (CAL). Investigators will also evaluate the number of lost teeth.

To date, no published systematic review and meta-analysis has compared AHI-CPAPflow and AHI-PSGgold. Therefore, the primary objective of this study is to compare published data for AHI-PSGgold and AHI-CPAPflow in patients treated by CPAP.

Volunteer female and male individuals aged 20-65 years, followed in the State Hospital Internal Diseases Unit, diagnosed with obesity (BMI> 30 kg/m^2), and meeting the inclusion criteria will be included in the study. The control group will consist of healthy male and female individuals between the ages of 20-65 who have not been diagnosed with obesity. The demographic and clinical characteristics of the participants who voluntarily accepted to participate in the study will be questioned with the "Evaluation Form" prepared by the researchers, and the body compositions of the participants will be evaluated. The "Charlson Comorbidity Index (CCI)" will be used to determine the existing chronic diseases of the participants and to evaluate participants' comorbidities. Next; the "Incremental Shuttle Walk Test (ISWT)" will be applied to determine exercise capacity. In addition, in order to determine the level of physical activity, a "pedometer" device will be given to the participants, participants will be asked to carry the device on them for 7 days, and at the end of the period, the pedometer data will be recorded. At the same time, participants will be required to fill in the "International Physical Activity Questionnaire-Short Form (IPAQ-SF)". Participants will be asked to fill in the "Stop-Bang Test" to assess the risk of sleep apnea, the "Obesity-Specific Quality of Life Scale (OSQOL)" to assess the health-related quality of life, and the "Hospital Anxiety and Depression Scale (HADS)" to determine the anxiety and depression level of the participants. Handgrip strength will be evaluated with a hydraulic hand dynamometer. Assessments take an average of 45 minutes is planned.

The need for multiple night testing is well recognized in sleep medicine because of a considerable and relevant night-to-night variability. In a study with multiple recordings using WatchPAT®, the OSA severity of 24% of patients was misclassified when using one night compared to the average of three nights. On average, pAHI varied by 57% from night-to-night. The variability of pAHI could partially be explained by the variability of time spent in the supine position with more time supine leading to a higher pAHI (Tschopp et al 2021). Smith (2007) suggested that the AHI should be indicated with a confidence interval to indicate the uncertainty regarding its true value. The Minimal Detectable Difference (MDD) is of special interest in sleep medicine, especially when assessing treatment effects. MDD was found to be 12.8/h and the standard error of measurement was 4.6/h for 4 nights of polysomnography (Aarab et al. 2008). For WatchPAT®, measuring two and three nights showed a small reduction in MDD from 19.1/h to 18.0/h (Tschopp et al. 2021, in press). Only one study using pulse oximetry assessed the night-to-night variability over 14 days (Stöberl A. et al 2017). The study confirmed the enormous variability and focused mainly on its impact on OSA severity. While the night-to-night variability has been extensively studied for polysomnography, respiratory polygraphy, and WatchPAT®, little is known about the optimal number of nights to be recorded. There is convincing evidence from the literature, that the recording of multiple nights is the only way to assess the severity of the patient's disease with clinically reasonable accuracy. Moreover, the MDD with only one night's recording is astonishingly high. The question is how many nights should be recorded to achieve acceptable diagnostic accuracy. The precision of the OSA measurement depends on the clinical situation. For example, to diagnose severe OSA, a higher variability might be acceptable without influencing the treatment decision. However, when comparing treatment effects, the MDD should be as small as possible. The recording of multiple nights might be cumbersome for patients (e.g. with polysomnography or respiratory polygraphy) as well as costly. These factors have to be taken into consideration for the clinically feasible number of recordings. Sleepiz One Connect offers the unique opportunity for a contactless recording of breathing combined with conventional pulse oximetry and is a minimally invasive diagnostic tool that allows measurements over several nights. Studies with multiple night recordings will offer a basis for diagnostic recommendations in future guidelines. The study aims to investigate the variability of obstructive sleep apnea at-home sleep apnea testing. By investigating the variability, we want to quantify the improvement in diagnostic accuracy by additional measurements. The hypothesis is that additional recordings offer a significant improvement in diagnostic accuracy by reducing the variability. The reduction in variability will diminish with each additional recording.

To evaluate the feasibility of a sensor-less sleep monitor (Somnofy®) in diagnosis and follow-up in obstructive sleep apnea. The study will explore the monitor's usefulness in detection of apnea during sleep, and compare the data to standard diagnostic registrations.

The management of OSA is multidisciplinary. Today, there are many self-evaluation questionnaires aiming at predicting or evaluating the severity of OSA. However, no clinical score takes into account the specificities of the ENT clinical examination, which is a major actor in the management of the disease. The aim of this study is to create a clinical score predictive of the diagnosis and severity of OSA, using already published data, completed with the specificities of the ENT clinical examination.

Main objective of this study is to assess the psychometric characteristics of the Mutuality Scale both in patients with Obstructive Sleep Apnea Syndrome (OSAS) and in their partners-The association between the mutuality score in OSAS patients and their adherence to the use of Continuous Positive Airway Pressure (CPAP) therapy will also be investigated. The results of the study may allow a validation of the Mutuality Score as an instrument for measuring mutuality between OSAS patients and their partners.

The purpose of this study is to identify whether pregnant women with chronic hypertension are at significantly higher risk of having undiagnosed OSA and should be routinely screened with home sleep tests. The investigators will recruit 120 pregnant subjects between 10-20 weeks gestation from the Duke High Risk Obstetrics Clinic over a 20-month period. They will be enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood pressures documented at 3 clinic visits); 2) normal blood pressure, and not on any treatment for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the chronic HTN group. The two groups will be matched for BMI to control for the effect of obesity on OSA diagnosis and cHTN. The primary hypothesis, that OSA prevalence differs between patients with chronic HTN and normotensive controls, will be assessed with a two-group two-sided Fisher's exact test. A Fisher's exact test with a 0.05 two-sided significance level will have 92% power to detect the difference between a normotensive OSA rate of 0.10 and a chronic hypertensive OSA rate of 0.40 when the sample size in each group is 50. There are no risks associated with the use of the home sleep test device, but subjects that have a severe latex allergy should not participate, as the device