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Apnea clinical trials

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NCT ID: NCT01546792 Completed - Obesity Clinical Trials

Lifestyle Intervention in Obstructive Sleep Apnoea

Start date: January 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a common disorder characterised by interrupted breathing while sleeping. It is associated with cardiovascular problems such as high blood pressure, heart attack and stroke. Furthermore, most patients with OSAHS are overweight and have impaired quality of life. Lifestyle interventions incorporating exercise training, dietary advice and behaviour change have been shown to elicit favourable changes in quality of life, body mass/composition and cardiovascular risk in a range of patient groups. However, no study has investigated the impact of lifestyle modification on such health outcomes in patients with OSAHS. This study will address this issue by investigating the effects of a lifestyle intervention on quality of life, body mass/composition and cardiovascular risk in patients with OSAHS. A total of 60 volunteers will be recruited and randomly allocated to one of the two groups. Patients in the intervention group will be offered a 12-week individualised lifestyle programme consisting of supervised exercise training, dietary advice and behaviour change counselling. Patients in the control group will receive an educational booklet detailing healthy eating and exercise guidelines but no supervised or structured intervention. The results of this study will inform the design of a larger, multi-centre randomised controlled trial.

NCT ID: NCT01539278 Completed - Clinical trials for Sleep Apnea, Obstructive

Effect of Adenotonsillectomy on Quality of Life in Children With Mild Obstructive Sleep Apnea

Start date: February 2011
Phase: N/A
Study type: Interventional

In children, enlarged adenoids and/or tonsils are the most common cause of obstructive sleep apnea (OSA), which is temporary blockage of breathing during sleep. Surgery to remove the tonsils and adenoids is the first-line treatment for disorder, and has been shown to cure the majority of children. However, for children with only a mild degree of OSA and few symptoms, surgery is less clear-cut, since two-thirds of these children do not develop worsening disease. Research shows that some children with mild OSA and behavior problems are helped by removing the tonsils and adenoids. In children with all degrees of OSA, surgery has improved scores on tests that measure quality of life (QOL). The investigators hypothesize that children with mild OSA will demonstrate changes on QOL assessment following adenotonsillectomy. These findings may help to guide the surgeon in selecting the children with mild OSA who are more likely to benefit from surgery.

NCT ID: NCT01538069 Recruiting - Heart Failure Clinical Trials

Heart Failure and Sleep Apnea: Exercise Training and Continuous Positive Airway Pressure

CPAP
Start date: March 2012
Phase: N/A
Study type: Interventional

Introduction. Heart failure is the result of primary ventricular dysfunction followed by neurohormorais changes, distribution of cardiac output, peripheral circulation, the skeletal and respiratory muscles, which determine their clinical and prognosis. Despite the advancement in treatment, morbidity and mortality remain high. Physical training appears as a therapeutic strategy, because most of its beneficial effects is by inducing changes in peripheral physiological changes resulting from heart failure. Associated factors that may contribute to its progression and worse prognosis, now beginning to be studied, such as sleep apnea, the diagnosis provides important prognostic information and a potential therapeutic option for these patients. Objectives. Demonstrate the benefits of physical training for patients with heart failure and sleep apnea, and compare treatment with CPAP alone and associated with the exercise program. Will also be assessed risk and adherence to physical training. Material and Methods. The design will be prospective, longitudinal, randomized consecutive patients. After screening and baseline evaluations the patients will be randomized into Group 1 (CPAP, n = 20), Group 2 (CPAP + Physical training, n = 20), Group 3 (Physical Training, n = 20) and Group 4 (Control without intervention, n = 20). Outcomes (baseline and 3 months): Quality of sleep (polysomnography), Quality of life (Minnesota and SF-36), sexual function (QS-M and QS-F) and functional capacity (cardiopulmonary exercise testing and isokinetic testing). Physical training: aerobic and resistance exercises three times a week for three months. CPAP therapy:after polysomnography for titration with ventilator servo-assisted, and outpatient follow monthly, for three months.

NCT ID: NCT01535521 Completed - Clinical trials for Positional Sleep Apnea

Sleep Positional Trainer for Positional Sleep Apnea After Mandibular Advancement Device (MAD) Therapy

SupPos
Start date: n/a
Phase: N/A
Study type: Interventional

The investigators will perform a clinical trial comparing mandibular advancement device (MAD) therapy with sleep positional trainer (SPT) and the combination of MAD and SPT in patients with positional sleep apnea using MAD. Patients are invited for 2 consecutive polysomnographies (PSGs) in randomized order: one PSG with SPT, one PSG with SPT and MAD. PSGs are performed at the Antwerp University Hospital.

NCT ID: NCT01532180 Completed - Clinical trials for Sleep Apnea, Obstructive

Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)

Start date: November 2009
Phase: N/A
Study type: Interventional

The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).

NCT ID: NCT01532050 Completed - Clinical trials for Obstructive Sleep Apnea Syndrome

PROMAD: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea

PROMAD
Start date: February 2012
Phase: Phase 4
Study type: Interventional

The present research intends to focus clinically on selecting the right type of patient for mandibular advancement devices (MAD) therapy using screening tools such as advanced imaging and computational methods based on CT-Scan images as well as drug-induced sleep nasendoscopy techniques with simulation of the mandibular repositioning. The core of the research project relies on known and established methods accepted in several neighboring fields, but aims at the transfer of this knowledge by integrating it into this new domain. Doing so, the proposed biomedical research is directed towards clinical applications that incorporate innovative developments on the level of the diagnosis and therapy of a specific disease, being obstructive sleep apnea syndrome (OSAS). Furthermore, this study aims at registering objective compliance during MAD therapy.

NCT ID: NCT01530451 Terminated - Nocturia Clinical Trials

Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients

Start date: March 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy of desmopressin on symptoms of nocturia in patients with Obstructive Sleep Apnoea (OSA). The improvement of sleep quality and the quality of life will be measured.

NCT ID: NCT01525160 Completed - Clinical trials for Obstructive Sleep Apnoea Hypopnoea Syndrome

New Markers to Measure Clotting in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome

Start date: October 2011
Phase: N/A
Study type: Observational

Obstructive Sleep Apnoea Hypopnoea Syndrome(OSAHS)affects at least 4% of males and 2% of females. OSAHS is the combination of excessive daytime sleepiness, snoring and apnoeas (stopping breathing at night). As well as affecting tiredness, mood, concentration and quality of life - there is growing concern that it can increase the risk of high blood pressure, heart problems, strokes and thromboses (clots in the veins). It appears that OSAHS may affect the thickness of the blood and cause it to clot more easily it also causes damage to the lining of the blood vessels (endothelial injury). These effects seem independent of other risk factors such as obesity, smoking, family history of clots etc. The investigators are testing new biomarkers: gel point and fractal dimension developed at the Swansea University to measure the 'clotting' of the blood in people with OSAHS and a similar group of people who snore and who are sleepy but do not have OSAHS on sleep studies (Controls) Also markers of vascular inflammation are being measured.

NCT ID: NCT01524510 Recruiting - Clinical trials for Obstructive Sleep Apnea Syndrome

Validation of Functional Imaging as Predictive Tool for Outcome of Mandibular Replacement Appliance Therapy in Obstructive Sleep Apnea Hypopnea Syndrome Patients

Start date: February 2011
Phase: Phase 4
Study type: Interventional

In this open prospective study 40 patients who received Mandibular Replacement Appliance (MRA) Therapy as treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) will be included. The patient's sleep will be registered during 2 periods of 2 days: one while the patient does not wear the MRA and, +/- 1 week later, one while the patient wears the MRA. Furthermore, 2 low dose CT scans (one with and one without the MRA device in the mouth) will be taken. These data must allow the investigators to validate the use of functional imaging (segmentation and Computational Fluid Dynamics) as a predictor of the outcome of the MRA therapy in OSAHS patients.

NCT ID: NCT01517763 Terminated - Clinical trials for Sleep Apnea, Obstructive

Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients

Start date: January 2012
Phase: N/A
Study type: Interventional

A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can improve therapy adherence when compared to standard care with a fixed pressure Continuous Positive Airway Pressure (CPAP) device and compared to a less aesthetically pleasing CPAP device without technologies (AutoCPAP, SensAwake™, ThermoSmart™) in patients previously diagnosed with moderate-severe obstructive sleep apnea (OSA).