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Insomnia clinical trials

View clinical trials related to Insomnia.

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NCT ID: NCT00569972 Completed - Insomnia Clinical Trials

A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia

Start date: October 2007
Phase: Phase 2
Study type: Interventional

To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.

NCT ID: NCT00568789 Completed - Insomnia Clinical Trials

Safety of Ramelteon in Elderly Subjects

Start date: June 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate the effects of ramelteon in elderly subjects on balance, mobility and memory impairment after awakening in the middle of the night following bedtime dosing.

NCT ID: NCT00566371 Completed - Insomnia Clinical Trials

The Effect of a Once Daily Dose of Atomoxetine (ATX) on ADHD-Related Insomnia in Children and Adolescents

Start date: June 2005
Phase: Phase 4
Study type: Interventional

This study is a single site, double-blind, randomized, placebo-controlled parallel group design. this study is designed to directly examine the efficacy of a single daily dose of atomoxetine taken in the morning in alleviating sleep initiation insomnia in children with ADHD. Primary outcome measures are sleep parameters, specifically mean sleep onset latency (time of onset to persistent sleep), as measured by actigraphy/sleep diary, and parent and child-reported evening settling difficulties, as measured on the evening subscale items of the parent and child versions of the DPREMB-R. Secondary outcome measures include: additional actigraphic sleep parameters (night wakings, sleep duration, and sleep efficiency), daytime sleepiness (Pediatric Daytime Sleepiness Scale, sleepiness visual analogue scale (VAS), and morning behaviors on the DPREMB-R); ADHD symptom improvement (ADHD-RS, parent version; provider-completed CGI); a neurocognitive measure of attention and impulsivity (CPT); executive functions (Brown ADD Scale for Children) and functional outcomes/quality of life (CHQ).

NCT ID: NCT00561821 Completed - Insomnia Clinical Trials

Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709)

Start date: November 20, 2007
Phase: Phase 3
Study type: Interventional

This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine) compared to placebo in elderly participants with chronic primary insomnia. Primary efficacy variable is Wake time After Sleep Onset (WASO), averaged over all in-treatment time points and measured by polysomnography (PSG).

NCT ID: NCT00534872 Withdrawn - Insomnia Clinical Trials

A Clinical Study to Evaluate the Pharmacokinetic Profile of SB-649868 in Elderly and Female Population

Start date: October 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the blood levels and the tolerability of SB-649868 in Elderly and Female population

NCT ID: NCT00525941 Withdrawn - Insomnia Clinical Trials

An Exploratory Study of NBI-34060 Capsules and Next Day Functioning

Start date: September 2007
Phase: Phase 3
Study type: Interventional

NBI-34060 is an investigational (research) medication being studied in people with insomnia. The current study is designed to evaluate how people, who experience a nighttime awakening with difficulty returning to sleep, feel during the next day after dosing with NBI-34060. The study will also examine the pattern and extent of nighttime awakenings as reported by the patients, as well as and the patient's sleep experience during treatment.

NCT ID: NCT00511134 Terminated - Insomnia Clinical Trials

Study of Lunesta Versus Placebo for Sleep Problems Related to Smoking Cessation and Zyban

Start date: April 2007
Phase: Phase 4
Study type: Interventional

Objectives: The primary objective of this study is to determine the efficacy of eszopiclone at treating sleep problems related to withdrawal from nicotine in healthy smokers attempting smoking cessation. Sleep disturbances are a significant problem for smokers who are trying to quit smoking. Smokers may be more likely to have sleep problems and both nicotine withdrawal and agents used to aid smoking cessation (e.g., pharmacotherapies) may disrupt sleep. Lunesta (eszopiclone) is a medication that has been approved by the FDA to treat insomnia. Eszopiclone's efficacy for treating insomnia makes it a promising agent for treating nicotine withdrawal-related symptoms of sleep disturbance. This study will be 7 weeks duration. All participants will begin taking Zyban at the beginning of week 1 and will be asked to try to quit smoking at the beginning of week 2. Participants will also begin to take Lunesta or matched placebo (3 mg qd x 6 weeks) on the target quit date at the beginning of week 2. All subjects will receive eight (8) weekly sessions of brief individual supportive smoking cessation counseling. Hypothesis: It is hypothesized that significantly fewer sleep problems will be reported by participants taking Lunesta as compared to placebo. Specifically, it is expected that participants taking Lunesta will report less difficulty falling and staying asleep, higher sleep quality, and less insomnia-related fatigue and distress than participants taking placebo.

NCT ID: NCT00507546 Completed - Insomnia Clinical Trials

Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

Start date: July 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if replacing melatonin function with a melatonin agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia) helps to alleviate self-reported sleep disruption.

NCT ID: NCT00506389 Completed - Insomnia Clinical Trials

A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)

Start date: June 6, 2007
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.

NCT ID: NCT00494468 Completed - Insomnia Clinical Trials

Single Dose Pharmacokinetic and Pharmacodynamic Evaluation of Three Different Doses of Zolpidem in Children

Start date: October 2002
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter trial to evaluate the single-dose safety, tolerability and pharmacokinetics-pharmacodynamics of Zolpidem in a group of children with sleep disturbances stratified by age and dose.