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NCT ID: NCT02541318 Recruiting - Sleep Disturbances Clinical Trials

Study of Effects of Dao-In Exercise on the Perimenopausal Women With Sleep Disturbance

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

Among health problems of peri-menopausal women, sleep disturbances is very common complaint. The aim of this study is to realize the body constitution of the peri-menopausal women with sleep disturbance; and to evaluate the effects of Duo-in practice on this population to see if this intervention can decrease the dosage of hormone replacement therapy. Quasi-experimental design and convenient sampling are both adopted. Participants will be recruited from China Medical University, Tri-Service General Hospital, Taiwan Society of Health Promotion, and Dr. Chen's Obstetrics and Gynecology Clinic. One hundred of participants who are willing to try Duo-in exercise to improve their sleep quality will be randomly assigned into experiment group and control group. The experiment group will practice Duo-in exercise 20 minutes every day for 2 months; while there is no intervention in the control group. Then, after 2 weeks, the participants of experiment and control group will crossover. The experiment group has no intervention, but the control group will practice Duo-in exercise for 2 months. Chinese version of the Pittsburgh Sleep Quality Index (CPSQI), Body Constitution Questionnaire (BCQ), peri-menopausal disturbance scale, and peri-menopausal fatigue scale will be used in the assessment at each time point. According to previous experience, a total of 70 participants will completed the whole observation course. Generalized estimating equations (GEE) is applied to analyzed the repeated measurement of different time and groups. This study will provide the evidence for Duo-in exercise as complementary treatment for hormone replacement therapy for peri-menopausal women, and also for integration of Dao-in exercise into mainstream treatment for other patients with sleep disturbance.

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: 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: 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: NCT02037971 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Aerobic Exercise on Improving Sleep in Systemic Lupus Erythematosus.

EFEXO
Start date: February 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effectiveness of exercise training on improving sleep in patients with systemic lupus erythematosus.

NCT ID: NCT02036996 Recruiting - Sleep Disorders Clinical Trials

Evaluation of EarlySense; a Contact-less Heart and Respiration Rate Monitoring in Sleep Lap Examined

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

The objective of this study is to collect heart rate, respiration data and motion data of patients admitted to sleep lab and to determine the current accuracy level of the EarlySense system vs. the standard system, and predicate device for EarlySense (Embla) used in sleep lab in monitoring heart rate and respiration rates monitors (ECG, respiratory belts, oximeter) that are currently used in the sleep lab among different population (Obese, patients with or without apnea, patients with or without arrhythmia). It is emphasized that no interpretations or clinical decisions will be made based on data received from the ES study device.

NCT ID: NCT01966835 Recruiting - Clinical trials for Rheumatoid Arthritis

Effect of Moderate to High Intensity Aerobic Interval Training on Polysomnographic Measured Sleep in Patients With Rheumatoid Arthritis

JR
Start date: May 2013
Phase: N/A
Study type: Interventional

Poor sleep quality and sleep disturbances are common in patients with rheumatoid arthritis and are associated with an increased risk of co-morbidity and all-cause mortality.Few studies have examined the possibilities of improving sleep in patients with rheumatoid arthritis, and the focus has primarily been on medical treatment. Aerobic exercise training constitutes a potentially promising, non-pharmacological alternative to improve sleep. This study is a randomized controlled trial of 44 patients with rheumatoid arthritis. The aim is to investigate the effect of a moderate-to-high intensity aerobic interval training intervention on sleep quality and sleep disturbances in patients with rheumatoid arthritis. The primary hypothesis is that moderate-to high intensity aerobic exercise will improve objective measured sleep quality and sleep disturbances. The secondary hypothesis is that the intervention may improve fitness, subjective sleep quality and physical function as well as reduce pain, fatigue, depressive symptoms and improve health-related quality of life.

NCT ID: NCT01924507 Recruiting - Clinical trials for Acute Myocardial Infarction

Bedside Sleep Medicine

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

The investigators aimed to evaluated the role of bedside sleep medicine in an cardiology intensive care unit. The patients will be submitted to a overnight polysomnography. Those individuals with sleep apnea will be treated with CPAP during the ICU admission. Also, the investigators will identify the factors that compromise the sleep and will act to minimize them to improve the sleep quality. After the interventions, the investigators will evaluate if there are reduced days of hospital admission, major cardiovascular events (infarction, reinfarction, heart failure and stroke) and overall mortality.

NCT ID: NCT01922999 Recruiting - Clinical trials for Chronic Kidney Disease

Different Doses of Oral Melatonin Supplements in Chronic Kidney Disease (CKD)-Associated Sleep Disorders

Start date: December 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The study will evaluate the safety and efficacy of melatonin supplementation in CKD and ESRD patients with sleep disorders to reduce sleep latency times, the number of apnea/hypopneic episodes, and prolong duration in rapid eye movement (REM) sleep in CKD and ESRD patients with sleep disordered breathing.