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Insomnia clinical trials

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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: 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.

NCT ID: NCT00484497 Completed - Insomnia Clinical Trials

Evaluation of a Food Supplement on Sleep Quality

Cyclamax
Start date: September 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.

NCT ID: NCT00482612 Completed - Insomnia Clinical Trials

Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)

RUBY
Start date: December 7, 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.

NCT ID: NCT00466193 Completed - Insomnia Clinical Trials

A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia

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

The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.

NCT ID: NCT00465972 Completed - HIV Infections Clinical Trials

The Treatment of Insomnia in Patients With HIV Disease

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

This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are HIV positive and suffer from insomnia.

NCT ID: NCT00462618 Completed - Insomnia Clinical Trials

Group Cognitive Behavioral Therapy (CBT I) Vs. Quetiapine for Residual Insomnia Impairing Recovery Among Elderly With Stable Major Affective Disorders

Start date: April 2007
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this pilot study is to assess feasibility and patient accessibility in order to design an adequately powered study to compare group cognitive behavioral therapy for insomnia (CBT-I) to quetiapine in non-demented patients aged 60 years or older with controlled bipolar disorder (I or II) or major depressive disorder who suffer from residual insomnia.