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Sleep Wake Disorders clinical trials

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NCT ID: NCT02108353 Completed - Clinical trials for Sleep Disorders, Circadian Rhythm

Circadian Phase Adjustment and Improvement of Metabolic Control in Night Shift Workers

Start date: January 2015
Phase: Phase 3
Study type: Interventional

EuRhythDia II is a multicenter, randomized, double-blind controlled study. The rationale of EuRhythdia is to explore the effects of 12 weeks of timed melatonin treatment on circadian rhythm, metabolic control and cardiovascular function in night shift workers. The 12 weeks of intervention will be followed by 12 weeks of washing out.

NCT ID: NCT02061514 Recruiting - Surgery Clinical Trials

The Effect of Two Different General Anesthesia Regimes on Postoperative Sleep Quality

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

- Major surgery can lead to postoperative disturbances in sleep patterns with subjective deterioration of sleep quality according to patients' reports as well as objective alterations of sleep architecture, as recorded by polysomnography - Factors implicated in postoperative sleep disturbances include but are not limited to the severity of the surgical procedure, the neuroendocrine response to surgery, inadequate treatment of postoperative pain and external factors interfering with sleep, such as light, noise and therapeutic procedures - There are differences in the molecular mechanisms inhalational anesthetics and intravenous agents affect different brain regions to induce anesthesia. Our hypothesis is that these differences may also be evident during the postoperative period, affecting brain functions which are involved in postoperative sleep architecture. So, the aim of this study will be to assess the effect of two different anesthetic techniques (propofol versus desflurane) of maintaining general anesthesia in patients subjected to similar major operations - Patients will be assessed with the Pittsburgh Sleep Quality Questionnaire (PSQI), regarding preoperative and long term postoperative sleep quality, sleep diaries regarding early postoperative sleep quality and biochemical markers (cortisol, prolactin and melatonin) regarding neuroendocrine response to surgery and disturbances in endogenous circadian secretion associated with sleep

NCT ID: NCT02059421 Active, not recruiting - Clinical trials for Sleep Disturbances in Survivors of Critical Illness

Johrei Therapy and CBT-I in Facilitating Sleep in ICU Survivors

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

The purpose of this project is to compare the effectiveness of Johrei therapy (JT) and Cognitive-behavioral Therapy for Insomnia (CBT-I) in the treatment of sleep disturbances in survivors of critical illness. Subjects will be recruited following discharge from the Intensive Care Unit (ICU) and followed for 6 weeks. All subjects will undergo objective measurements of sleep quality and duration at baseline and at 6 weeks. Objective measurements will be made by portable (home-based) sleep studies and will wear a watch that measures sleep. Subjective measurements will be performed by sleep questionnaires: PSQI, Epworth sleepiness scale, sleep log, and Stanford Sleepiness Scale which will be performed at baseline, 2 and 6 weeks. A blood draw and urine collection will be done at both baseline and 6 weeks. The central purpose of this proposal is to perform a comparative-effectiveness study of a complementary and alternative approach (Johrei therapy) and CBT-I in the treatment of sleep disturbances in survivors of critical illness. The investigators hypothesize that, in survivors of critical illness, Johrei therapy is superior or comparable to CBT-I in improving sleep quality (Pittsburgh Sleep Quality Index [PSQI] and sleep efficiency [measured by polysomnography]). A secondary objective is to compare the effect of Johrei therapy and CBT-I on systemic markers of inflammation and urinary biomarkers of sleep and stress. The investigators hypothesize that, in survivors of critical illness, Johrei therapy is superior or comparable to CBT-I in reducing systemic markers of inflammation and urinary biomarkers of sleep and stress. A tertiary objective is to determine whether the presence of insomnia or other sleep characteristics is associated with hospital readmissions within 30-days.

NCT ID: NCT02043977 Completed - Insomnia Clinical Trials

Efficacy and Safety Study of Propofol Infusion for Refractory Chronic Primary Insomnia

Start date: June 2013
Phase: Phase 1
Study type: Interventional

Insomnia is a widespread condition in which approximately one-third of adults in the United States are symptomatic with 6% of the population meeting the diagnostic criteria for insomnia. There is an increased risk of insomnia in certain segments of the population including women, middle-aged and older adults, shift workers and individuals with medical or psychiatric disorders. Individuals with insomnia have a decreased quality of life compared to those who report other serious illnesses such as major depression and congestive heart failure. Chronic insomnia can be caused by medications, drug or alcohol abuse, psychiatric disorders, medical and neurologic disorders. It can impair cognitive and physical functioning. Propofol is an approved drug administered intravenously for use in the induction and maintenance of anesthesia or sedation. Some research suggests that propofol when administered as a two hour infusion may improve the ease of sleep onset, sleep quality, ease of awakening and the integrity of behavior following waking. This study will be conducted in the Broward Health Medical Center Sleep Lab, under the direct care of a Board Certified Anesthesiologist, dedicated to the study involving participants who have refractory chronic primary insomnia and have not responded to conventional pharmacologic therapies within the past 90 days. Each qualifying participant will receive an IV infusion of the study medication for 5 consecutive nights. Assessments including polysomnography with completion of questionnaires will occur at screening, Days 1 through 5 of study product administration, Day 6 and Day 90. Follow-up questionnaires will also be distributed on Day 180.

NCT ID: NCT02037438 Completed - Insomnia Clinical Trials

Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study

SMART DOCS
Start date: January 2014
Phase: N/A
Study type: Interventional

Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART DOCS) was designed to develop and evaluate a new approach (patient-centered outcomes and coordinated-care management [PCCM]) for the diagnosis and treatment of sleep disorders. Specialized and pertinent information and resources regarding sleep disorder management were developed and made available through an online portal, allowing patients to make informed health care decisions, and providers to assist patients in achieving what they feel are the most important goals regarding their care. Half of participants were randomized into the conventional diagnosis and treatment (CONV) arm and the other half into the patient-centered outcomes and coordinated-care management (PCCM) arm. Validated objective and subjective assessment measures were administered at intervals throughout a 13 month participation period in both the CONV and PCCM arms to determine whether the new PCCM approach for sleep medicine results in increased patient satisfaction, quality of care, and improved health outcomes. Qualifying participants were 18 years of age or older and presenting with a new sleep disorder. Patients received no monetary compensation.

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: NCT02025959 Completed - Sleep Clinical Trials

Sleep for Inpatients: Empowering Staff to Act

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

Getting better sleep in the hospital is especially important due to a variety of adverse health effects that can potentially worsen patient recovery. To address these concerns and improve sleep in US hospitals, we aim to develop the SIESTA (Sleep for Inpatients: Empowering Staff to Act) program as an educational intervention designed to prepare hospital staff to assist patients in obtaining better sleep in hospitals and recognize the importance of screening for sleep disorders. The major educational goals of this proposal is to develop and pilot test an online educational program (SIESTA) which aims to train and motivate medical professionals to provide better sleep for hospitalized patients. We will utilize data from an ongoing sleep study, performed by the research team at the University of Chicago that looks at how adult patients are able to sleep while they are in the hospital, as a means of education for the participating medical staff.

NCT ID: NCT02002533 Completed - Sleep Disorder Clinical Trials

Brief Behavioral Therapy in Improving Sleep Disorders in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy

Start date: February 3, 2014
Phase: N/A
Study type: Interventional

This randomized phase II trial studies how well brief behavioral therapy works in improving sleep disorders in patients with stage I-III breast cancer undergoing chemotherapy. Sleep disorder counseling may reduce fatigue and insomnia as well as improve the well-being and quality of life in patients with breast cancer who are undergoing chemotherapy.

NCT ID: NCT01993251 Completed - Sleep Disorders Clinical Trials

Does Melatonin Restore Sleep Architecture in Autistic Children

SOMELIA
Start date: June 2014
Phase: Phase 2
Study type: Interventional

Although behavioral disorders origins in autistic children are still unclear, they seem to be influenced by sleep disorders. Results of studies performed on sleep quality in autistic children showed a high prevalence of sleep disorders in these children, estimated between 50 and 80% compared to children with typical development and insomnia is one of the sleep disorders most frequently reported by autistic children's parents. Others studies showed circadian rhythm disorder in autistic children which could be the consequence of genetic abnormalities in the melatonin synthesis and the melatonin role in the synaptic transmission modulation. Melatonin by its sedative effects and its action on circadian pacemaker is a promoter of sleep proposed for insomnia treatment and circadian rhythm disorders. Two major recent studies (not yet published) in the United States and in England seek to show the effectiveness of melatonin by testing the effects of three doses of melatonin on reducing sleep disorders. It is therefore interesting and important to conduct a parallel study to assess the melatonin effect not only on the reduction of sleep disorders (sleep onset latency, total sleep timeā€¦), but on sleep quality (number of nocturnal awakenings). The strength of this study lies in the combination of several measurement tools to assess the melatonin dose-effect on all parameters in both physiological (actimetrics, polysomnography), biological (dosage 24h sulfatoxymelatonin), behavioral (sleep questionnaire, index of insomnia severity, rating scale autistic disorder) as well as possible side effects. The primary objective is to determine the most effective dose of melatonin to improve sleep quality in autistic children.

NCT ID: NCT01978340 Withdrawn - Clinical trials for Sleep Apnea, Obstructive

Eval EarlySense Bet Lowenstein Sleeplab

Start date: November 2013
Phase: N/A
Study type: Observational [Patient Registry]

The study objective is to collect heart rate, respiration rate and motion data of patients admitted to sleep lab and to determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab (e.g., Polysomnography, respiratory belts, ECG, etc..) . Data regarding sleep condition, scoring and quality of sleep and in and out of bed status, patient turns will also be collected and compared to data collected by EarlySense contactless monitor. Different patient population will be monitored including obese, morbidly obese, patients with or without obstructive/central apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored