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The objective of the study is to determine if treatment with Ramelteon will help to improve insomnia in older adults with co-existent insomnia and sleep apnea. The primary study objective is sleep latency (a measure of insomnia). The hypothesis is that sleep latency will be reduced in subjects taking Ramelteon relative to the placebo arm. The secondary study objective is to determine if subject compliance with CPAP treatment of their sleep apnea is improved in subjects taking Ramelteon (their compliance may be improved because they would have less insomnia due to Ramelteon treatment when using their CPAP). The hypothesis is that compliance with CPAP will be improved in subjects taking Ramelteon relative to the placebo arm.
Randomized, double-blind, placebo-controlled, parallel arm clinical trial with two study arms.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
University of Pennsylvania
University of Pennsylvania
Published on BioPortfolio: 2014-07-23T21:11:08-0400
The purpose of this study is to determine the efficacy of Rozerem in subjects with mild to moderate Alzheimer's Disease and sleep disturbance
To study the effect of Rozerem, a high affinity MT1 and MT2, low affinity 5-HT2B receptor agonist used for insomnia, as a migraine prophylactic agent.
The purpose of this research study is to evaluate the safety and efficacy of ramelteon (Rozerem™) as an add-on treatment for sleep problems in patients with bipolar disorder. This study ...
Acupuncture is widely used for treatment of insomnia. The research hypothesis is that acupuncture may be more effective than sham acupuncture to treat insomnia during pregnancy. GAS is a ...
Insomnia is a common and distressing symptom for patients on hemodialysis (HD), and there is evidence for a much larger impact on the health of patients. Chronic insomnia is disrupted slee...
There is limited evidence about the role of herbal and traditional medicine in pregnancy-related insomnia. Extant documents on traditional Persian medicine refer to many plants which could induce slee...
Partial or non-response to antidepressants in Generalized Anxiety Disorder (GAD) is common in clinical settings, and adjunctive biological interventions may be required. Adjunctive herbal and nutraceu...
There is limited research on the association between insomnia and negative self-conscious emotions. This study assessed if individuals with insomnia reported higher scores in self-disgust than normal ...
It has been suggested that insomnia patients with short sleep duration and insomnia patients with normal sleep duration may respond differently to cognitive behavioral treatment for insomnia (CBT-I). ...
Insomnia is a risk factor for new onset, exacerbation, and relapse of mental illness. The goal of this study was to examine the prevalence, severity, and predictors of insomnia in hospitalized psychia...
An autosomal dominant disorder characterized by degeneration of the THALAMUS and progressive insomnia. It is caused by a mutation in the prion protein (PRIONS).
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
A hypnotic and sedative used in the treatment of INSOMNIA.
A benzodiazepine used in the treatment of anxiety, alcohol withdrawal, and insomnia.
Sleep disorders disrupt sleep during the night, or cause sleepiness during the day, caused by physiological or psychological factors. The common ones include snoring and sleep apnea, insomnia, parasomnias, sleep paralysis, restless legs syndrome, circa...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...