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Insomnia clinical trials

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NCT ID: NCT01236105 Completed - Insomnia Clinical Trials

Effect of Activated Charcoal and Time of Dose on the Pharmacokinetics of LY2624803 in Healthy Subject

Start date: October 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the effect of activated charcoal and dosing time on the absorption of LY2624803 in healthy subjects. In this crossover study, there are three treatments with a washout period of at least 7 days in between treatments. Each subject will participate in all three treatments with random assignment to the treatment sequence.

NCT ID: NCT01224912 Completed - Insomnia Clinical Trials

Internet Delivered Self-Help CBT for Insomnia

Start date: October 2010
Phase: Phase 3
Study type: Interventional

The object of this study is to determine variables associated with therapy-success of a cognitive behavioral self help intervention for insomnia. In this study all participants receive an online self-help CBT manual consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.

NCT ID: NCT01209728 Completed - Insomnia Clinical Trials

Effects of Insomnia on Simulated Driving (MK-0000-183-00)

Start date: October 1, 2010
Phase: Phase 1
Study type: Interventional

This is a double-blind, parallel design study in elderly primary insomnia patients and demographically matched controls. The objectives if this study are primarily: 1. To determine if functional deficits in simulated driving performance can be demonstrated in primary insomnia patients, and detected in healthy volunteers, impaired by alcohol; and secondarily: 2. To compare simulated driving performance deficits in elderly primary insomnia patients to those in healthy elderly volunteers impaired by alcohol, for at least one of the following driving endpoints: standard deviation of lane position (SDLP), standard deviation of speed (speed deviation), lane excursions, and a driving composite score.

NCT ID: NCT01207050 Active, not recruiting - Insomnia Clinical Trials

Effect of Rozerem on Sleep Among People With Traumatic Brain Injury

Start date: September 2010
Phase: Phase 4
Study type: Interventional

This pilot study proposes to examine the effect of Rozerem on sleep/wake patterns among individuals with Traumatic Brain Injury (TBI) experiencing sleep disturbance, using both objective and subjective measures. It will also show that improvement in sleep/wake patterns resulting from Rozerem will impact daytime functioning using objective and subjective measures.

NCT ID: NCT01188460 Completed - Chronic Pain Clinical Trials

A Cognitive-Behaviour Therapy (CBT) Self-Management Approach for Insomnia in Chronic Pain: A Randomized Control Trial

Start date: April 2010
Phase: N/A
Study type: Interventional

This study will test the impact of a cognitive-behavioural self-management approach for the management of insomnia among patients with chronic pain. This self-management approach consists of a manual describing cognitive behavioural techniques for the management of insomnia. In terms of primary outcomes, it is anticipated that there would be improvements in sleep-related dimensions such as sleep quality, sleep efficiency, and night-time awakenings in the sample group receiving a copy of the self-help manual intervention to be implemented by participants in their home (intervention group), relative to the group receiving treatment as usual (control group). In terms of secondary outcomes, it is anticipated that the intervention group will show improvements in mood, fatigue, pain severity, and pain-related disability relative to the control group. The tertiary outcome variable of pre-sleep arousal is anticipated to have a moderating or mediating relationship with the sleep variables investigated.

NCT ID: NCT01180855 Active, not recruiting - Insomnia Clinical Trials

Effects of Ramelteon (8mg) Alone and in Combination With Multi-Component Behavioral Therapy on Sleep and Circadian Phase in Patients With Chronic Insomnia

CBT
Start date: August 2007
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT01162655 Completed - Insomnia Clinical Trials

Cognitive-Behavioural Therapy (CBT) for Insomnia Via Internet or Telehealth

Start date: April 2010
Phase: N/A
Study type: Interventional

Cognitive-Behavioural Therapy (CBT) is an effective treatment for chronic insomnia, which is a prevalent and costly problem. This pilot study will compare the effectiveness of two brief (6 week) psychological interventions delivered to residents of rural Manitoba using Telehealth or an interactive Internet-based platform. It is hypothesized that a) participants in the Telehealth condition will report significantly greater improvements in sleep parameters(e.g., sleep efficiency, time awake in bed, sleep-onset latency),insomnia severity, and daytime fatigue than those in the Internet condition and that b)participants in the Telehealth condition will show better adherence to treatment and greater satisfaction with treatment than those in the Internet condition.

NCT ID: NCT01161108 Completed - Epilepsy Clinical Trials

Trial of Melatonin to Improve Sleep in Children With Epilepsy and Neurodevelopmental Disabilities

Start date: July 2010
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of oral melatonin in improving sleep continuity in children with epilepsy and neurodevelopmental delay who have chronic insomnia by comparing Fast Release Melatonin (FR MLT) to placebo and Timed Release Melatonin (TR MLT) with placebo in a randomized cross-over design trial.

NCT ID: NCT01159197 Recruiting - Depression Clinical Trials

Cognitive-Behavioral Therapy for Sleep Disturbance in Patients Undergoing Hemodialysis

Start date: August 2009
Phase: N/A
Study type: Interventional

Background More than 50% of dialysis patients experience sleep disturbances that significantly affect quality of life, overall morbidity, and mortality. There is no effective therapy except hypnotics, which have notable side effects. Cognitive-behavioral therapy (CBT) is effective for treating peritoneal dialysis (PD) patients, the elderly and cancer patients with chronic insomnia, but its effectiveness has never been reported in hemodialysis (HD) patients and its impacts on the inflammatory cytokines, oxidative stress and autonomic dysfunction in this population are unknown. The investigators investigated the effectiveness of CBT in HD patients by assessing changes in sleep quality, inflammatory cytokines, oxidative stress and autonomic dysfunction. Objects This study is designed to assess the effectiveness of CBT on sleep disturbance in insomnias HD patients. The investigators also evaluate the impacts of CBT on the inflammatory cytokines, oxidative stress and autonomic dysfunction in these insomnias HD patients. Methods The investigators expected to recruit 80 insomnias HD patients undergoing maintenance HD for more than 3 months for the investigation. Besides, 40 HD patients without sleep disturbance will be recruited for comparison. Patients with sleep disturbance (N=80) was randomized to either intervention (CBT) group (N=40) or control group (N=40). Participants in CBT group will receive 6-week CBT while in control group and patients without sleep disturbance only receive sleep hygiene education. The subjects were assessed at baseline and after the intervention with the Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), Beck depression index (BDI) and the International Index of Erectile Function (IIEF) for men and the Index of Female Sexual Function (IFSF) for women; and inflammatory cytokines (serum IL-1β, IL-18, and TNF-α levels), oxidative stress (TBARS, Total antioxidant status and serum 8-OHdG) and autonomic dysfunction (Baroreflex sensitivity, BRS) were measured. Expected results The investigators expect that CBT can improve the sleep disturbance in HD patients and may change the inflammatory cytokines, oxidative stress and autonomic dysfunction after the intervention in insomnias HD patients.

NCT ID: NCT01156051 Terminated - Insomnia Clinical Trials

Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia

Start date: June 2010
Phase: Phase 4
Study type: Interventional

This study seeks to determine, using special sleep tests (polysomnography and actigraphy) if guanfacine extended release is able to improve nighttime sleep in children with ADHD - associated insomnia while improving daytime ADHD symptoms. Male and female children with diagnosed or suspected ADHD with sleep problems (difficulty falling asleep, difficulty staying asleep, or less than expected hours of sleep) will be recruited. After obtaining informed consent and assent (when appropriate) and after discontinuation of excluded medications, children will have evaluations of his or her sleep and evaluations confirming the ADHD diagnosis. Children who successfully pass screening will be enrolled into the double-blind, placebo-controlled, randomized investigation with 50% of participants receiving guanfacine extended release and 50% of participants receiving matching placebo. Using a flexible-dose optimization design based on ADHD symptom improvement and medication tolerability, the dose will be adjusted between 1 to 4 mg over the course of four weeks. At the end of medication adjustment (week 4 or 5), ADHD questionnaires, sleep questionnaires, and sleep tests will be repeated and analyzed. The medication will be weaned over the course of the following 3-10 days.