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NCT07466888
This single-group interventional study investigates the safety and physiologic effects of functional electrical stimulation (FES) applied to the tongue and submental muscles in adults at high risk for sleep apnea. Participants will receive five stimulation frequencies (15, 25, 35, 45, and 75 Hz) in randomized order during a single visit. Ultrasound and tongue pressure (IOPI) measurements, as well as subjective assessments of discomfort and perceived effects, will be conducted before, during, and after stimulation. The primary objective is to evaluate changes in muscle thickness, length, and tongue strength across different stimulation frequencies. Secondary objectives include assessing participant discomfort, safety, and subjective treatment effects.
NCT07103941
This study is evaluating two standard-of-care strategies used to prevent bite changes (occlusal changes) in patients treated with a Mandibular Advancement Device (MAD) for sleep-related breathing disorders such as obstructive sleep apnea (OSA). While MAD therapy is effective, it can lead to changes in how the teeth fit together, including the development of a posterior open bite. Participants in this study will be randomly assigned to one of two standard-of-care approaches: using an interocclusal aligner each morning after removing the MAD, or performing daily jaw exercises. Both methods aim to reduce the risk of occlusal changes. The study will follow participants over a 3-month period and includes dental evaluations, 3D oral scans, and short daily surveys. Findings from this research may help guide best practices for preserving occlusion during MAD therapy.
NCT06797089
Mouth breathing, snoring and poor sleep can contribute to and worsen periodontitis (gum disease). The purpose of this study is to test whether the myTAP oral appliance with a mouth shield (OA+) can lessen periodontal symptoms in those with these conditions over a 12 week period. In addition to testing sleep respiration and quality, it will also evaluate periodontal pathogens and systemic stress in subjects treated with OA+. This split-mouth clinical trial will include adults with mild to moderate periodontist who snore and mouth breath. All will receive comprehensive periodontal care in addition to OA+ therapy.
NCT07097597
This study will compare the output of a new snoring application against another commercially available application and polysomnography (either home or in-laboratory).
NCT05756647
This is a randomized controlled trial for non-apneic snorers. The primary goal of the study is to evaluate the efficacy of a mandibular advancement device (MAD) vs conservative treatment for adults with non-apneic snoring as measured by the partners report of response to treatment (CGI-I). The secondary goal is to evaluate the effectiveness of treatment of snoring on the Epworth Sleepiness Scale (ESS), a modified Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) questionnaire, the Pittsburgh Sleep Quality Index (PSQI), and the Clinical Global Impression of Severity Scale (CGI-S)
NCT06330116
Objective the present project aims to assess the impact of 1) oral screen training, group training, and the use of neuromuscular electrical training (NMES) as orofacial myofunctional therapy (OMT) methods for reducing the apnea-hypopnea index (AHI) among adults with mild to moderate sleep apnea and 2) if these different training methods can reduce snoring and affect the level of sleepiness and quality of life. Study design The study will use a prospective randomized open-blinded endpoint (PROBE) design with baseline measurements, intervention phase, and follow-up measurements. Methods 141 consecutive adult subjects, 71 men and 70 women referred to hospital, due to symptoms of snoring and mild to moderate sleep apnea will be randomized, included, and examined at three different sites, Umeå(Sweden), Lund(Sweden) and Köge(Denmark) One hundred-five of them, 35 in each treatment group, will receive one of the three different forms of training and the final 36 persons serving as controls, age/AHI matched (18 in Köge resp Umeå). Participants in Umeå will be randomized to either training with IQoro® or serving as controls. Participants in Köge will be randomized to either training with Exciteosa®, group training, or controls. The primary outcome is a change in AHI before and after three months of training with the different methods according to overnight ambulatory sleep apnea recordings. The secondary outcomes are change in snoring frequency, sound level dB (A) according to a questionnaire, the Basic Nordic Sleep Questionnaire (BNSQ), daytime sleepiness using the Epworth Sleepiness Scale (ESS), change in quality of life using the short form -36 (SF-36) and muscle strength in tongue before and after treatment.
NCT05719779
Evaluation of the Tolerance and Benefits of Mandibular Advanced Device (MAD) for Snoring and Sleep Apnea in Patients with Oropharyngeal Cancer (OPC): Mixed Design Study.
NCT02767843
This pilot study will examine the efficacy and safety of continuous negative external pressure ("cNEP") for the treatment of chronic snoring in people without obstructive sleep apnea.
NCT03640793
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): A Pilot Study.
NCT01918007
Obstructive sleep-disordered breathing (SDB) in childhood is a disorder of breathing during sleep characterized by intermittent upper airway obstruction. Snoring, labored breathing and apneas reported by the parents are the most frequent symptoms.Obstructive SDB can result from many different abnormalities including large adenoids and tonsils or obesity. Intermittent upper airway obstruction during sleep is accompanied by low oxygen or high carbon dioxide in the blood and arousals from sleep. If obstructive SDB is not treated, complications may develop such as: i) enuresis; ii) delay in somatic growth rate; iii) central nervous system morbidity (e.g. hyperactivity and learning difficulties); and iv) elevated blood pressure. Overnight polysomnography (PSG) is considered the gold-standard method for defining severity of obstructive SDB and subgroups of children with snoring who should be treated. However, PSG is a labor-intensive, time-consuming and expensive diagnostic method, which is not available in many community settings. Thus, there is an urgent need for developing easy-to-use and low-cost diagnostic methods which can be used to determine severity of obstructive SDB and define subgroups of children with snoring and large adenoids and tonsils who will benefit from adenotonsillectomy (AT). Pulse oximetry is a widely available, non-invasive method which allows continuous monitoring of oxygen transport by hemoglobin. Episodes of upper airway obstruction are frequently accompanied by reductions in the hemoglobin oxygen transport (oxygen desaturation of hemoglobin).The hypothesis of this research project is that subgroups of children with snoring and adenotonsillar hypertrophy and certain abnormalities in oxygenation detected by nocturnal pulse oximetry will benefit from AT in a community setting.
NCT04876625
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.
NCT03701165
To measure the effect of the DryMouth Shield on snoring.
NCT03829956
Intraoral Neuromuscular Training for Treatment of Snoring Objective Studies show that improving pharyngeal muscle tone can ameliorate obstructive sleep apnoea (OSA) and snoring. The study uses an intra-oral stimulation device (SnooZeal) aimed at a population of snorers. The aim of this study is to assess the efficacy of intra-oral neuromuscular stimulation training during wakefulness on snoring. Methods This is a prospective study, recruiting up to 200 patients from the sleep clinics. In this study, subjects will use the intra-oral stimulation device once a day for 20 minutes each time for a period of 6 weeks. During these 6 weeks, subjects will complete a daily diary of the device use and any side effects or adverse events. Partners also complete a daily snoring score. Subjects will be followed-up for a further 2 weeks after treatment. They will complete Pittsburgh Sleep Quality Index (PSQI) and subjective sleep quality questionnaires for a further 2 weeks. Partners will also complete the post treatment snoring scores. Sleep study will be repeated. Outcome measures The objective evaluation will be based on pre- and post-treatment sleep studies, visual analogue scale (VAS) snoring scores, PSQI and subjective sleep quality questionnaire. All side effects and adverse events will be reported and acted upon according to the risk management structure.
NCT04086407
This study evaluates the correlation of the position of the head during sleep, independent of the position of the torso, and the severity of apnea hypopneas in obstructive sleep apnea.
NCT04324671
This study aims at :- 1. detecting the prevelance of snoring and OSA in non-obese patients 2. identify their diagnostic profile in order to provide proper management
NCT02470182
The purpose of this study is to learn more about breathing disorders during sleep. The investigators want to learn how breathing sounds made during sleep relate to breathing disorders during sleep.
NCT03398044
Adenotomy, together with tonsillectomy, belongs among the most frequently performed surgical procedures in paediatric patients. These surgical procedures are associated with the second highest incidence of post-operative nausea and vomiting (PONV) (following strabism correction surgery) in paediatric surgery. PONV is associated, apart from the discomfort for the child, with a number of complications: dehydration, metabolic disruption or danger of haemorrhage and aspiration of the gastric content. Adenotomy is a typologically completely different surgical procedure, with a different target structure of the surgery, and the length and invasiveness of the procedure. Thus, it is possible to expect a difference in PONV incidence when compared to tonsillectomy. Adenotomy is a surgical procedure performed namely in children of the pre-school age. This is associated, among others, also with the problem of objectivization of post-operative nausea, which is very difficult to verbalize in small children, being a subjective feeling of body discomfort. It is possible to expect that the overall incidence of PONV will be significantly underestimated.
NCT02688335
This is an interventional study in which patients with a history of habitual snoring will use the low-pressure CPAP device at home for about 4 weeks. This study is designed to document the adherence of the snorer, the acceptance and comfort of the therapy, and bed partners' subjective report of improvement in sleep quality, and/or reduction or elimination of snoring. Study outcomes will consist of an assessment of the nightly usage time, and questionnaires that the snorer and the bed-partner have to complete before the start of the study and at the end of the study period.
NCT02364518
The purpose of this study is to assess the safety and effectiveness of TranQuillTM Sling (a suture or thread used in surgery that is knotless) in snoreplasty (surgery procedure) for the treatment of snoring and mild OSA in adult subjects. The TranQuill Sling Snoreplasty (QSS) is a procedure where the suture will be inserted into the soft palate tissues for the treatment of snoring and/or mild obstructive sleep apnea. Soft palate tissues are tissues in the back of the roof of the mouth. The research results will be used to provide data on feasibility (strengths and weaknesses), safety, performance, and effectiveness data for the Surgical Specialties, Inc as a therapy for snoring and/or mild obstructive sleep apnea. The TranQuillTM Sling is approved by the U.S. Food and Drug Administration (FDA). The TranQuillTM Sling is used in all types of surgery that involved deep tissues in the body. The investigator in charge of the study is Dr. Boyd Gillespie. MUSC and Dr. Gillespie receive financial support from Surgical Specialties, Inc. to conduct the study. MUSC is the only place that this study will be conducted. For this research study the investigators plan to enroll a total of up to 20 subjects at the Medical University of South Carolina.
NCT03222193
The Tongue Right Positioner (TRP Snorless™) is a medical device designed to restore physiological tongue positions when functioning or at rest and increase tongue muscles tone. Patient wears TRP Snorless™ daily at least 5 hours during night. Published data suggested that TRP Snorless™ increases oropharynx diameter and nasal patency, favouring airflow in upper airways. Independently of patient's adherence to daily myofascial exercises, the TRP Snorless™ treatment should increase tongue muscles' tone and decrease the risk of snoring during sleep.