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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT00468052 Completed - Clinical trials for Obstructive Sleep Apnea

Pain Relief for Children Undergoing Tonsillectomy & Adenoidectomy

Start date: March 2007
Phase: Phase 3
Study type: Interventional

Pediatric tonsillectomy (with or without adenoidectomy) is a brief but painful surgery carried out in children who very often also present with obstructive sleep apnea. To provide pain relief, i.e. analgesia, current practice relies on opioids , e.g., morphine or fentanyl. These narcotics are known to depress respiration and to increase the incidence of post-operative nausea and vomiting. These side effects are worrisome in this patient cohort. An alternative medication, dexmedetomidine, may have an opiate sparing effect and has a high safety profile in adults as well as in sedation in children. The purpose of this study is to determine if intravenous dexmedetomidine given as an infusion during general anesthesia for tonsillectomy or adenotonsillectomy reduces the incidence and severity of emergence agitation, improves analgesia and reduces nausea and vomiting in the 60 minutes following surgery.

NCT ID: NCT00466011 Completed - Clinical trials for Obstructive Sleep Apnea

Validation of the Stardust Cardio-Respiratory Recorder

Stardust
Start date: April 2007
Phase: N/A
Study type: Observational

Introduction: The full night polysomnography (PSG) in sleep lab is the gold standard to Obstructive Sleep Apnea (OSA) diagnosis. However, there is a need to evaluate simple and accurate home diagnostic equipment that can reliably detect or exclude OSA. The aim of our study was to evaluate if an ambulatory portable monitor (SD) is accurate to measure apnea-hypopnea index (AHI) in OSA patients referred to a Sleep Lab. Methods: Patients with clinical suspicion of OSA were selected. Three-order randomized evaluations had been performed within a period of two weeks: the 1) SD (Stardust®, Respironics, Inc, USA) was used at patients home (SD home), 2) SD was used simultaneously with PSG in the sleep lab (SD+PSG lab) and 3) PSG was performed without the use of SD (PSG lab). Four AHI were generated and analyzed: AHI from SD home, AHI from SD of SD+PSG lab, AHI from PSG of PSG+SD lab and AHI from PSG lab. The analyses of SDs and PSGs recordings were performed by two blinded technicians.

NCT ID: NCT00464659 Completed - Memory Deficit Clinical Trials

Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome

Start date: April 2007
Phase: N/A
Study type: Interventional

The main objective of this study is to evaluate the evolution of memory deficit (verbal episodic memory, procedural memory, working memory, short-term memory) in Sleep Apnea Obstructive Syndrome (SAOS) patients after treatment by Continuous Positive Airway Pressure treatment (CPAP). For thus, we will compare memory tests in two separate groups of SAOS patients with "effective " versus "ineffective" ( or sham) CPAP, before and 6 weeks after the beginning of the treatment. Thus we will assess the evolution of memory deficit, the effectiveness of the treatment on the evolution of memory deficit before and 6 weeks after the beginning of the treatment by "effective " versus "ineffective" CPAP. We feel the results of the tests of memory will show greater memory disorders in patients with SAOS before beginning the treatment rather than six weeks afterwards. Thus we hypothesise that, after the treatment by "effective" CPAP, the patients with SAOS will have greater improvement of their memory disorders than those treated by "sham CPAP".

NCT ID: NCT00462306 Completed - Pregnancy Clinical Trials

Incidence of Obstructive Sleep Apnea in Pregnancy

OSA
Start date: September 2005
Phase: N/A
Study type: Observational

Obstructive sleep apnea is a condition characterized by obstruction of the upper airways and episodes of apnea and hypopnea during sleep. It is associated with significant adverse health effects. The incidence of obstructive sleep apnea in the general female population is approximately 2% but the incidence of obstructive sleep apnea in pregnancy is unknown. There is some evidence that pregnancy precipitates or at least exacerbates this condition and that there may be a relationship between intrauterine fetal growth retardation and maternal preeclampsia. In addition, there are several anesthetic implications that are concern for the patient with obstructive sleep apnea. These include: exquisite sensitivity to all central nervous system depressant drugs and the potential for upper airway obstruction or apnea with even minimal drug doses; difficult mask ventilation; difficult intubation; arterial hypoxemia; arterial hypercarbia; polycythemia; hypertension; pulmonary hypertension and cardiac failure. All of these conditions pose significant anesthetic risk for the patient, and this risk may be increased further by pregnancy.

NCT ID: NCT00458406 Completed - Clinical trials for Obstructive Sleep Apnea

Evaluation of Adherence and Therapeutic Effectiveness of Bi-Flex Versus CPAP in Children With OSA

Start date: May 2007
Phase: N/A
Study type: Interventional

Context: The obstructive sleep apnea syndrome (OSAS), i.e., snoring with difficulty breathing during sleep, is common in children. Continuous positive airway pressure (CPAP) therapy is the usual treatment for children who do not improve following surgery. However, CPAP is uncomfortable and is often not tolerated. We therefore plan to study a modification of bilevel positive airway pressure therapy, BiPAP with Bi-Flex that may be more comfortable. Objectives: The primary objective of this study is to determine whether BiPAP with Bi-Flex results in improvement in adherence as compared to CPAP. The secondary objective is to determine whether Bi-Flex has similar therapeutic efficacy compared to CPAP, as determined by sleep study. Additional objectives include comparing CPAP and Bi-Flex effects on comfort and determining which parameters predict adherence. Study Design/Setting/Participants: A single center, randomized controlled double-blind study of Bi-Flex vs CPAP use in children with OSAS over a 3 month period. Intervention: Bi-Flex vs CPAP Study Measures: Objective compliance recordings, sleep study results, subjective questionnaire results. .

NCT ID: NCT00456573 Completed - Clinical trials for Obstructive Sleep Apnea Syndrome

Cytokine Profiles in Children With Obstructive Sleep Apnea

Start date: April 1, 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the cytokine profile of tonsillar and peripheral blood mononuclear cells in patients with obstructive sleep apnea (OSA) and to compare the blood mononuclear cell cytokine secretion profile between patients with obstructive sleep apnea and controls without apnea.

NCT ID: NCT00435643 Completed - Obesity Clinical Trials

Influence of nCPAP on Metabolic Consequences Associated With OSAS

Start date: October 2004
Phase: N/A
Study type: Interventional

Context: Obstructive sleep apnea syndrome (OSAS) is associated with cardiovascular morbidity. Recurrent episodes of occlusion of upper airways during sleep result in hormonal changes that may predispose to high cardiovascular risk.These risks can rapidly be reduced by effective nasal continuous positive airway pressure (nCPAP) therapy Objective: To evaluate hypothalamic pituitary adrenal axis, insulin resistance, blood pressure values and adipokines in severe obese patients with and without OSAS and to determine if continuous positive airway pressure therapy (nCPAP) influenced responses.

NCT ID: NCT00425659 Completed - Sleep Apnea Clinical Trials

Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea

Start date: January 2007
Phase: N/A
Study type: Interventional

Newer home sleep study device and algorithm provides an alternative for inpatient sleep study and improve the service provides to patients

NCT ID: NCT00410085 Completed - Healthy Clinical Trials

Renal Hemodynamics and Tubular Function in Patients With Obstructive Sleep Apnea and Healthy Controls

Start date: January 2005
Phase: Phase 4
Study type: Interventional

Nitrogen-oxide (NO) plays an important role for blood pressure regulation, renal hemodynamics, and the renal excretion of sodium. NO is synthesized from L-arginine in the vascular endothelium and have a very short half-life in plasma and is therefore very difficult to measure directly. L-mono-methyl-L-arginine (L-NMMA) is an analogue to L-arginine and a competitive inhibitor of NO, and therefore can be used to study the effect of NO on the circulation. In normal subjects, infusion of L-NMMA will cause an increase in blood pressure, decreased renal plasma-flow, decreased glomerular filtration rate, and a decreased excretion of sodium. Hypothesis: Patients with obstructive sleep apnea has a decreased activity in the NO-system. This is contributing to the hypertension often seen in these patients. Decreased activity in the NO-system can be revealed by diminished fall in renal hemodynamic and sodium excretion after infusion of L-NMMA.

NCT ID: NCT00409487 Completed - Clinical trials for Obstructive Sleep Apnea

Effects of Continuous Positive Airway Pressure and Valsartan Treatments on Arterial Blood Pressure in OSAS Patients

VALSAS
Start date: December 2006
Phase: Phase 4
Study type: Interventional

The main objective of the study is to compare the decrease of mean arterial blood pressure over 24 hours in patients having obstructive sleep apnea syndrome and weak or moderate hypertension, treated by Valsartan 160mg per day versus continuous Positive Airway Pressure.