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Dyssomnias clinical trials

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NCT ID: NCT00792077 Completed - Leukemia Clinical Trials

A Pilot Study to Investigate the Effect of Cytotoxic Therapy and/or Radiotherapy on Cancer Related Sleep Disturbances in CLL and Breast Cancer Patients Experiencing Fatigue

Start date: November 2008
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if treatments to kill cancer cells including lenalidomide and/or radiation therapy can help to control symptoms such as sleep problems and fatigue in patients with chronic lymphocytic leukemia (CLL) and/or breast cancer.

NCT ID: NCT00750919 Terminated - Mental Disorders Clinical Trials

Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)

Start date: October 7, 2008
Phase: Phase 3
Study type: Interventional

This trial is a 26-week, open label extension trial to investigate safety and explore efficacy of esmertazapine in participants with insomnia who completed protocol 21106/P05701/MK-8265-002 (NCT00631657).

NCT ID: NCT00748098 Completed - Clinical trials for Restless Legs Syndrome

Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance

Start date: October 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.

NCT ID: NCT00694447 Completed - Pain Clinical Trials

Acupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis

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

The hypotheses of this study are: In the older population with knee OA, - When acupoints are chosen for both sleep and pain, there are additive effects on sleep improvement and pain relief (i.e. no interaction). - Main effects of acupuncture on sleep improvement and pain relief are anticipated when acupoints are separately targeted for sleep and for pain, respectively.

NCT ID: NCT00691080 Completed - Sleep Problems Clinical Trials

Understanding Sleep Problems in Children With Autism Spectrum Disorder

REST
Start date: September 2007
Phase: Phase 2/Phase 3
Study type: Observational

The investigators will examine whether sleep problems in children with autism spectrum disorder (ASD) are related to alterations in the production of melatonin (MT), a hormone that plays an important role in regulating sleep-wake cycle. Children with ASD experience high rates of sleep disturbances that potentially contribute to problems with thinking and behavior. It is unclear if changes in MT production cause sleep problems in children with ASD. MT is frequently used to treat these sleep problems; however, it has not been well established whether MT is an effective treatment. Our hypotheses concerning MT is children with ASD and sleep problems will have a delayed sleep-wake cycle and/or decreased MT production. This study will compare children diagnosed with ASD to "healthy" control children with no ASD diagnosis. All subjects will be recruited from one of three sites: Baylor College of Medicine, Oregon Health & Science University and Columbia University. The investigators will use a standardized questionnaire to determine whether the child has sleep problems. The investigators will measure MT levels in saliva in ASD children with sleep problems and in a group of control children without sleep problems. Total 24-hour MT production will be determined from urine samples in these same two groups.

NCT ID: NCT00690196 Active, not recruiting - Mental Disorders Clinical Trials

Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms

Start date: March 2008
Phase: N/A
Study type: Interventional

Breast Cancer is the most common cancer in women. After completion of successful therapy, may behavioral symptoms persist with over 20% of breast cancer survivors reporting chronic insomnia of greater than 6 months duration that fulfils clinical diagnostic criteria with associated functional limitations, decreased quality of life, and possible effects on long-term survival. Behavioral interventions are highly efficacious in the treatment of insomnia and preferred over hypnotic medication when insomnia is chronic. However, insomnia studies conducted in cancer are scarce. The proposed research builds upon program of study that has examined the efficacy of mind-body intervention, Tai Chi Chih (TCC), on health outcomes including sleep impairments. Preliminary studies show that TTC, a slow moving meditation, contributes to improvement in subjective sleep quality, sleep amounts and sleep efficiency. The investigators have further found that sleep, fatigue and proinflammatory cytokine activity are reciprocally related and that TCC decreases the mechanism through TCC carries its effects on sleep outcomes.

NCT ID: NCT00641186 Completed - Parkinson Disease Clinical Trials

Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)

Xyrem
Start date: September 2004
Phase: Phase 2
Study type: Interventional

This clinical trial is designed to evaluate the safety and potential efficacy of Xyrem for the treatment of excessive daytime sleepiness (EDS) and nocturnal sleep disturbance in patients with mild to moderate Parkinson's Disease (PD).

NCT ID: NCT00631657 Completed - Mental Disorders Clinical Trials

A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)

Start date: March 4, 2008
Phase: Phase 3
Study type: Interventional

To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081, SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia. Primary efficacy variable is Total Sleep Time (TST).

NCT ID: NCT00628342 Completed - Clinical trials for Gastroesophageal Reflux Disease (GERD)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)

Start date: April 2003
Phase: Phase 4
Study type: Interventional

This study includes patients with sleep disturbances associated with gastroesophageal reflux disease (GERD) and has 3 treatment arms. Patients will receive only one of the following treatment arms: esomeprazole 20 mg once daily, esomeprazole 40 mg once daily, matching placebo once daily. The relief to the sleep disturbances will be assessed.

NCT ID: NCT00596713 Completed - Healthy Clinical Trials

Epidemiology of Sleep Disturbances Among the Adult Population of the Sao Paulo City

Start date: June 2007
Phase: N/A
Study type: Observational

Sleep disturbances are of great relevance within the context of public health as they affect a sizable portion of the population with far reaching consequences. Many automobile and labor accidents as well as poor school and work performance can be traced to sleep disturbances, which are also linked to cardiovascular disease, metabolic syndrome, and psycho-cognitive alterations. OBJECTIVES: 1. Establish the epidemiologic profile of sleep disturbances among the adult population of the city of Sao Paulo in 2007; 2. Investigate associations between sleep patterns and disturbances in that population, taking into account the following variables: social-demographic status, anthropometrics, clinical, activity/rest cycle, eating and physical activity habits, mood disturbances, sexual dysfunction in males, alcoholism, drug addiction, genetic markers, biochemical, hematological, endocrine, immunologic and inflammatory indicators; 3. assess the compatibility of the results collected in the current study with those of epidemiologic sleep investigations of said city carried out in 1987 and 1995 with the aim of determining the secular sleep disturbance trend. METHODS: The two-stage cluster randomized sample included 1100 individuals of the city of Sao Paulo, representing the population proportionally to gender, age groups and social classes. Data were amassed as follows: 1. the application of home and institution questionnaires; 2. description of the sleep patterns and disturbances through polysomnography and actigraphy, performed at the Sleep Institute; 3. collection of peripheral blood for biochemical, hematologic, endocrine and genetic assays. STATISTICS: Subsequent to double typing (inputting) and analysis of data consistency, descriptive and analytical statistical assessments will be performed with the aim of describing patterns of sleep disturbances associated to the explanatory variables under investigation. In the light of bi-varied analysis, predictive/explanatory multivaried models were adjusted.