Active clinical trials for "Sleep Initiation and Maintenance Disorders"

This study looks at two different interventions used for the treatment of insomnia in survivors of breast, colon, lung, prostate and gynecologic cancer.

Depression with ongoing insomnia is a common clinical presentation with patients. Clinical data suggests that patients with insomnia that receive concomitant treatment with a sleep aid experience a more robust antidepressant response along with a quicker response. The purpose of this clinical study is to compare the effectiveness of the FDA-approved insomnia medication suvorexant, also known as Belsomra®, as add-on treatment to an antidepressant to that of placebo plus antidepressant treatment in patients with depression and residual or ongoing insomnia.

Insomnia and depression are two of the most prevalent mental health disorders and often co-occur. Health disparities in rural America and among African-Americans are well documented. The investigators propose an R34 exploratory project to test the feasibility of delivering high-fidelity insomnia and depression psychological services to an underserved population. Treatment of Insomnia and Depression in Elders (TIDE) is a pilot study that will treat rural, predominantly African-American older adults who present to their primary care physician with co-occurring insomnia/depression. Stage 1 will be an uncontrolled case study series (n = 10) focusing on treatment development/refinement and patient acceptability. In stage 2, feasibility will be experimentally tested with 46 participants randomized to integrated cognitive-behavior therapy (CBT) + usual care or to usual care only in an effectiveness pilot study. The treatment will combine/integrate compact CBT for insomnia (including relaxation, sleep restriction, and stimulus control) and for depression (including cognitive therapy and behavioral activation). The experimental intervention comprises delivering CBT services by videoconferencing to patients in primary care settings who live in rural areas. Treatment will be evaluated by pre, post, and follow-up self report instruments on insomnia, depression, and quality of life. In addition, the stage 1 pilot will use investigator designed quantitative and qualitative measures to evaluate critical process variables including patient acceptability of the video format, patient acceptability of the treatments, and obstacles to adherence. Depending on stage 1 data, these measures may be incorporated into stage 2 as well. Several innovative features of this exploratory project include: intervening with CBT on both disorders hoping to gain a synergy by their combined presentation; use of telehealth to deliver treatment to distant locations; translation of efficacy findings to an effectiveness trial; treatment will be delivered in the primary care setting, the preferred locale of rural, older adults; the study will extend knowledge of the range of CBT applications by enrolling under-represented groups with respect to ethnicity, literacy, and financial resources. The primary aims of this project are (1) to determine the feasibility and maximal therapy characteristics of integrated CBT for co-occurring insomnia/depression in both the case study series (stage 1) and the experimental investigation (stage 2), (2) collect pilot data on whether participants receiving integrated CBT + usual care show comparable or greater reductions in insomnia symptoms compared to participants receiving usual care at posttreatment and follow-up, and (3) collect pilot data on whether participants receiving integrated CBT + usual care show comparable or greater reductions in depression symptoms compared to participants receiving usual care at posttreatment and follow-up.

Many women with breast cancer who are treated with aromatase inhibitor medications develop difficulty sleeping and fatigue during treatment. Some examples of aromatase inhibitor medications include anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara). Frequently, sleeping pills do not work very well to improve sleep. Cyclobenzaprine (Flexeril) is a medication that was originally developed to treat muscle spasms. It may also improve sleep in patients with chronic pain disorders, such as fibromyalgia. In this study we are testing to see if cyclobenzaprine at bedtime will help improve sleep in women treated with aromatase inhibitors.

The aim of this clinical study is to observe the therapeutic effect of acupuncture and intradermal acupuncture in the treatment of insomnia Participants were randomized into the acupuncture group and control group. Both groups were treated 3 times in a week and assessed before and after the treatment. Hypothesis : Acupuncture group will produce superior effect in the treatment of insomnia compared with control group. Acupuncture group will produce superior improvement in anxiety, depression, quality of life, sleep log, recognition, attention, and memory.

The specific aims of the proposed study are to compare the sleep, daytime functioning, and circadian phase effects of ROZEREMTM (ramelteon/TAK-375) a selective MT1/MT2 melatonin receptor agonist in humans alone and in combination with multi-component behavior therapy (MCBT) in patients with chronic insomnia.

Preliminary studies suggest that the response to antidepressant medication can be accelerated by targeting insomnia with adjunctive use of eszopiclone. It is not yet known what mechanism(s) support this acceleration in response, though preliminary findings support the hypothesis that early restoration of sleep may facilitate BDNF-based effects of antidepressant medications. The optimal duration of co-treatment is also unknown. This study will test specific hypotheses about brain mechanisms and evaluate the effects of continued eszopiclone beyond the time window when response acceleration should be observed.

The primary hypothesis is that quetiapine will improve sleep in persons with Alzheimer's Disease (AD), with higher doses producing greater total sleep time and sleep efficiency.

HYPTHOTHESIS: The researchers hypothesize that application of active magnetic therapy vs. sham utilized while individuals sleep can reduce neuropathic pain in the spine and improve the quality of sleep. The null hypothesis is that treatment of subjects with spine pain with exposure to permanent/static magnetic fields has no measurable effect on neuropathic pain scores or quality of sleep scores.

Biolab Sanus is developing a product in the form of orodispersible tablet containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®. Thus, it is intended to evaluate the efficacy of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and Zolpidem Orodispersible 1.75 mg or 3.5 mg in men for the improvement of the maintenance insomnia disorder, through the evaluation of the Insomnia Severity Index, and using a Sleep Diary throughout the study, as well as to evaluate the latency of the sleep after a spontaneous or provoked wake up measured by polysomnography.