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Sleep Disorders clinical trials

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NCT ID: NCT02453633 Not yet recruiting - Sleep Disorders Clinical Trials

Theory Based SMS Reminders - Text's Impact on Patient Attendance

Start date: May 2015
Phase: N/A
Study type: Interventional

The project will be done at the ear, nose and throat outpatient department at Lovisenberg Diakonale Hospital (LDS) in 2015-2016. About 12% of patients with appointments at the surgical outpatient clinic at LDS do not attend their appointment even after receiving both letters and shot message service (SMS) reminders. Persuasion theory suggests that the SMS reminders may be more effective if the text appeals more to the patient's feelings. The project is designed as a randomized controlled trial in which the control group receives the standard text that has neutral content and the intervention group receives a more emotion-based SMS reminder. The aim is to determine whether the more emotional text reduces the proportion of patients who do not show up for their scheduled appointment at the surgical outpatient clinic.

NCT ID: NCT02452606 Recruiting - Parkinson Disease Clinical Trials

Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease

Start date: March 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the genetic variants of clock and narcolepsy genes that determine the therapeutic effects of Stalevo® on the quality of sleep in patients with Parkinson's Disease.

NCT ID: NCT02403492 Completed - Obesity Clinical Trials

Treatment of Obstructive Sleep Apnea in Children: An Opportunity for Cardiovascular Risk Modification

TREAT
Start date: August 2013
Phase: N/A
Study type: Interventional

Heart disease is a major cause of ill-health and death in adults. The risk factors for heart disease, if present in children, carry over into adult life. Childhood obesity has reached epidemic proportions in Canada and is associated with many heart disease risk factors such as high blood pressure. Another complication of obesity is obstructive sleep apnea. Sleep apnea is marked by snoring at night, pauses in breathing and low oxygen levels and occurs in up to 60% of obese children, but it is diagnosed in less than 20% of obese children. Importantly, sleep apnea in children, like obesity, is linked with high blood pressure and heart disease. Thus, children with sleep apnea who are obese are likely to have an increased risk for high blood pressure and heart disease. Currently, there is little knowledge of the extent of heart disease in obese children with sleep apnea. The best treatment for both obesity and sleep apnea is weight loss. Weight loss strategies are generally not very successful and since 75% of obese children will become obese adults, urgent treatments are needed to reduce heart disease in the long-term. Treating sleep apnea in obese children may be one of the ways to reduce heart disease. Sleep apnea can be treated with continuous positive airway pressure (CPAP), which involves wearing a mask attached to a breathing machine while asleep. It is unknown how effective CPAP is in reducing heart disease in obese children. The investigators will recruit children with sleep apnea who are obese and test for heart disease risk. The investigators will then treat these children with CPAP. After 6 months of CPAP, the investigators will repeat the tests to determine if CPAP lowers the risk for heart disease. At the end of the 6 months, those receiving CPAP will be randomized to either continue CPAP or discontinue CPAP for a 2 week period. At the end of the 2 week period the participants will repeat the tests again to determine the magnitude of the effect of CPAP. The investigators expect that CPAP treatment for sleep apnea in obese children will reduce blood pressure and lower heart disease. These results will increase awareness of the dangers of sleep apnea in obese children, which will facilitate early diagnosis and treatment, ultimately reducing heart disease long-term.

NCT ID: NCT02387320 Recruiting - Pain Clinical Trials

Evaluation of a Self-Care Toolkit in Surgical Breast Cancer Patients

Start date: July 2014
Phase: N/A
Study type: Interventional

This randomized controlled trial (RCT) in newly-diagnosed breast cancer patients seeks to determine the effectiveness of a self-care toolkit on specific symptoms associated with surgery as compared to a standard care group.

NCT ID: NCT02369705 Completed - Sleep Disorders Clinical Trials

Validation of Ambulatory Sleep Test (WP200/U) Compared In-lab Sleep Testing in Cardiac Subjects

Start date: June 2015
Phase: N/A
Study type: Observational

Subjects with cardiac disorders will be tested in the sleep laboratory with a conventional full-night PSG recording along with WP 200/WP200U ambulatory sleep diagnostic device in a synchronized manner. The PSG data will be scored manually by a trained polysomnographic scorer, according to standard criteria for this clinical routine. The data obtained by the WP200/WP200U will be analyzed automatically for RDI, AHI, sleep stages, snoring (optional) and body position (optional), in addition to parameters specific to cardiac subjects. The analysis will be performed by the WP200/WP200U software (zzzPAT) and will be compared to the PSG's manual scoring which serves as a "Gold Standard".

NCT ID: NCT02321826 Completed - Insomnia Clinical Trials

Music for Insomnia

Start date: April 2015
Phase: N/A
Study type: Interventional

The aim of this study is to determine the effect of listening to music on sleep quality (subjective and objective), daytime dysfunction and neurophysiological arousal in patients with insomnia.

NCT ID: NCT02296957 Recruiting - Sleep Disorders Clinical Trials

Impact of the Decrease of Exposure to Hypnosedative Drugs in the Elderly Through the Discontinuation of Hospital-initiated Prescription

HYPAGE
Start date: November 2014
Phase: N/A
Study type: Interventional

Brief Summary Context. Sleep disorders complaints are common in elderly and hypnosedative drugs are widely prescribed in community-dwelling elderly. Furthermore, acute hospitalisation may induce sleep disorders and hypnosedative initiation occurs in 14 to 29% of elderly during a hospital stay. These hospital-induced sleep disorders should spontaneously disappear after discharge and, because of their potential impact on falls, hip fractures, psychiatric side effects and induced dependence, hypnosedative drugs should therefore be discontinued at discharge in these naïve-treated patients. Adhesion to this recommendation is poor. Recent and on-going research on this topic mostly concerns adverse effects although these are already substantially documented and evidence-based, while there is a poor interest on developing research on potential strategies susceptible to practically improve the current adhesion to recommendations. Design and objectives. This project proposes multi-component intervention and is directed towards hospital prescribers, patients, and their general practitioner. It aims at discontinuing, at hospital discharge, the hypnosedative treatment that was initiated during hospitalization in naïve-treated elderly (ageā‰„65) patients. The value of the intervention, as compared to usual care management, will be estimated in a multicentre (6 hospitals gathering 8 centres: 5 internal medicine departments, 3 cardiology departments) randomised, cross-over, two-period trial. Two hospitals will gather 2 centres (2x2 centres) and 4 hospitals will gather only 1 centre (4x1 centres). An equilibrated randomization will be applied to the 8 centres, making sure that, in hospitals gathering 2 centres, these 2 centres will apply the same strategy in a given period and that the 2 hospitals will apply alternative strategies. This randomisation is set up to avoid the risk of a potential contamination between the 2 strategies from one centre to the other within the same hospital. As a result, 3 hospitals (including 4 medical departments) will apply the intervention during the first 11-month period, while the 3 others (including 4 medical departments) will apply usual care during this period, as a result of an equilibrated hospitals randomization. During the second 11-month period, each hospital will apply the alternative management. The two periods will be separated by a 1-month wash-out period. In all 240 patients (15 patients / centre) will be enrolled (120 in the intervention group and 120 in the usual care group). Patient follow-up duration will be 12 months after discharge. Patient status in regards with quality of sleep (study primary objective), hypnosedative consumption and frequency of falls (secondary objectives) will be collected by telephone interviews 1, 3, 6 12 months after discharge. Expected results. The results of the study should contribute to guide research and public decisions to practically decrease hypnosedative prescription and consumption, and associated adverse events.

NCT ID: NCT02277886 Recruiting - Sleep Disturbance Clinical Trials

Esomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and Sleep Disturbances

Start date: November 2014
Phase: Phase 4
Study type: Interventional

Among those patients experienced GERD symptoms, up to 89% report nocturnal symptoms, resulting in poor sleep quality. Sodium alginate oral suspension (Alginos) is a medication indicated for the relief of gastroesophageal reflux symptoms. This multi-center, open-label, randomized trial intends to compare the addition of one dose Alginos (50mg/ml, 20ml) at bed time (Nexium plus Alginos), with no additional alginate treatment (Nexium alone), in erosive GERD patients taking Nexium (40mg/tablet) daily for 4 weeks. Efficacy endpoints include percentage of patients with relief or complete resolution of nighttime heartburn (or regurgitation), percentage of patients with relief or complete resolution of GERD-related sleep disturbance, the percentage of nights without nighttime heartburn (or regurgitation) over treatment period, change from baseline of the Pittsburgh Sleep Quality Index (PSQI) questionnaire total score, and change of the percentage of patients with relief of nighttime heartburn (or regurgitation) at post-treatment visit as compared to final visit in test group (Nexium plus Alginos). Safety endpoint is incidence of adverse events. The study hypothesis is that sodium alginate plus esomeprazole is superior to esomeprazole alone in relieving nighttime reflux symptoms and sleep disturbance in erosive GERD patients.

NCT ID: NCT02260297 Completed - Sleep Disorders Clinical Trials

A Study of Wrist Actigraphy in Overweight and Obese Adults With Sleep Disorders

Start date: January 2014
Phase: N/A
Study type: Observational

70 overweight or obese adults with sleep disorders will be recruited for this study, in which the investigators aim to compare wrist actigraphy with polysomnography (PSG) for sleep monitoring. It is to evaluate the applications of Jawbone Up2 with the sleep parameters derived from this actigraphy.

NCT ID: NCT02245594 Not yet recruiting - Crohn's Disease Clinical Trials

GI Symptoms and Sleep Disturbances in Patients With Quiescent Crohns Disease

Start date: October 2014
Phase: Phase 0
Study type: Observational

In this study we would like to clarify the effect of long lasting Crohn's Disease on motility of the gastrointestinal system in patient and the effect regarding sleep disturbances. This will be done with a newly developed 3D-Motility-and-Transit-detector (Motilis Medica, Schweiz) and the well known polysomnographic equipment. Our hypothesises are: Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal colonic transit (primary endpoint). 1. Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal gastric emptying and small intestinal transit (secondary endpoints). 2. Total and segmental transit times found in patients with CD will be compared with corresponding transit times in healthy volunteers found in a previous study. 3. Patients with ileocoecal and/or colonic CD in remission have abnormal sleep patterns. 4. Nocturnal basic colonic activity, have changed in patients with ileocoecal and/or colonic CD in remission and sleep disturbances.