Treatment Trials

9 Clinical Trials for Various Conditions

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COMPLETED
Two Contrasting Interventions for Sleep Management
Description

This study will determine whether Mind-Body Bridging (MBB), a mindfulness training program is more effective than a common sleep medication, Zolpidem, in treating insomnia. It will also investigate whether MBB is additionally beneficial for co-morbid conditions such as stress, PTSD, depression, etc, compared with that of Zolpidem.

COMPLETED
An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia
Description

The purpose of this study is to compare an investigational drug (LY2624803) with placebo and with zolpidem in the treatment of outpatients with chronic insomnia.

COMPLETED
Behavioral Insomnia Therapy in Primary Care
Description

Insomnia reduces quality of life, increases risks for other illnesses, and enhances health care costs/utilization. Several efficacy studies have shown that Cognitive-Behavioral Therapy (CBT) for insomnia improves sleep and diurnal complaints among highly screened samples; however, its effectiveness among �real-world� primary care patients is yet to be tested. This project is highly relevant to the VA health care mission, given the high prevalence of insomnia in middle-aged and older adults. Pilot data from this VA suggest that 40% of primary care patients report trouble sleeping.

COMPLETED
Study of Eszopiclone Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause/Menopause
Description

To demonstrate improved subjective sleep in women with insomnia secondary to perimenopause or menopause following treatment with 3 mg of eszopiclone.

Conditions
COMPLETED
Treatment of Insomnia Secondary to Chronic Pain
Description

Several studies have shown that behavioral therapy for chronic pain can be beneficial for chronic pain and that behavioral therapy for insomnia can be beneficial for insomnia. However, seldom do chronic pain patients with insomnia receive a behavioral treatment for insomnia. The purpose of this study is to evaluate whether treatment for insomnia is helpful for pain and whether treatment for pain is helpful for insomnia. It will also assess whether a combined treatment is any more or less effective for pain or for sleep. Finally, the study will assess whether any of these treatments leads to improvements in immune function.

Conditions
COMPLETED
Robustness and Usability of the Dreem 3 System for at Home Sleep Monitoring in an Insomnia Population.
Description

There is an unmet medical need for monitoring sleep for multiple nights in a patient's home, without the inconvenience of traveling and staying overnight in a medical center, and without the need for a technician to set up a polysomnography (PSG) device at the patient's home. Several disorders, and particularly sleep disorders, are associated with insomnia symptoms, and longitudinal sleep assessment may support a better understanding and management of these patients, who currently seldom access sleep lab PSG. On one hand, this study aims at demonstrating whether the final device's user interface supports safe and effective use when being used at home over multiple nights. On the other, the study aims at confirming that stable and consistent data are measured in the device's actual use, for the records to be clinically usable in daily practice.

RECRUITING
Insomnia in Patients With Metastatic Lung Cancer
Description

This study evaluates how common insomnia (difficulties with sleep) is in patients with lung cancer that has spread from where it first started (primary site) to other places in the body.

WITHDRAWN
Insomnia in Patients Undergoing Chemotherapy and Radiation Therapy for Head and Neck Cancer
Description

RATIONALE: Learning about insomnia and quality of life in patients undergoing chemotherapy and radiation therapy for cancer may help doctors learn about the effects of treatment and plan the best treatment. PURPOSE: This clinical trial is studying insomnia in patients undergoing chemotherapy and radiation therapy for head and neck cancer.

COMPLETED
Automating Peer Learning to Reduce Alcohol Use and Related Deviant Behavior in Secondary School
Description

Deviant peer affiliation is one of the most important predictors of alcohol use in adolescence. These affiliations arise when socially marginalized youth self-aggregate and reinforce alcohol use and other deviant activity (i.e., "deviant peer clustering"). Existing efficacious school-based prevention programs generally have small effects and can be difficult to disseminate with fidelity and challenging to sustain due to complex designs and significant time-and-money expenditures required for materials and training. Existing school-based prevention programs have not provided compelling value to schools, which has limited their dissemination. The investigators found significantly lower rates of deviant peer affiliation and alcohol/tobacco use and moderate-to-strong suppressive effects on bullying, victimization, stress, and emotional problems, and strong positive effects on student engagement, achievement, and social-emotional skills in peer-learning intervention schools compared to control schools. However, teachers in intervention schools faced challenges implementing peer learning, including: (1) design fidelity: ensuring that peer learning provided the most positive student experience by including all the essential design elements; and, (2) instructional support: managing the flow and timing of the activities to complete the lesson on time while dealing with unexpected disruptions. Investigators developed an initial version of a mobile software application (PeerLearning.net) that provided easy-to-use organizational templates with workflow support that teachers used to automate the design and delivery of peer learning lessons. In this cluster randomized trial of the app, the investigators will use a sample of middle and high schools and conduct pre/post student assessments of peer relations, alcohol/drug use, antisocial/prosocial behavior, and social-emotional skills. They will also collect information on stress, bullying/victimization and related outcomes, including sleep quality and mental health. Investigators will also collect data on the frequency of lesson delivery with the app by teacher and school to assess dosage, which will be incorporated into our analyses. The investigators hypothesize that use of PeerLearning.net will have significant suppressive effects on alcohol use and related outcomes (i.e., tobacco/marijuana use, antisocial behavior, bullying, emotional problems) and promote increased levels of social-emotional skills and prosocial behavior. The investigators hypothesize that these results will be moderated by dosage (i.e., use of the app), such that greater usage yields larger effects.