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Sleep Wake Disorders clinical trials

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NCT ID: NCT00506259 Completed - Clinical trials for Sleep Disorders, Circadian Rhythm

Treatment Strategies for Children With Smith-Magenis Syndrome

Start date: July 17, 2007
Phase: Phase 1
Study type: Interventional

This study will examine the effect of bright light or melatonin treatment on sleep in children with Smith-Magenis syndrome (SMS), a genetic disorder characterized by certain physical, behavioral and developmental features. Patients have a disrupted sleep cycle involving early waking, frequent daytime napping and frequent nighttime awakenings. Melatonin is a hormone normally produced at night in healthy people. People with SMS produce high levels of melatonin during the daytime and very low levels at night. This may affect their behavior, mood, attention span and sleep patterns. Healthy volunteers between 18 and 45 years of age and children with SMS who are between 3 and 16 years of age may be eligible for this study. Healthy subjects are admitted to the NIH Clinical Center overnight. In the morning they take one dose of time-release melatonin and have blood and saliva samples collected hourly from 7:00 AM to 6:00 PM. Children with SMS participate in a 2-part study, as follows: Part 1 Inpatient Trial Pre-trial at-home phase: During the month before NIH inpatient admission, participants do the following: - Wear an actiwatch device or keep a daily sleep diary to monitor daytime alertness, mood shifts and sleep patterns. - Complete a behavior assessment survey related to the child s behaviors and sleep patterns. - Obtain frequent body temperature measurements. - Collect several saliva samples over a 24-hour period. NIH admission phase: - Children are admitted to the NIH Clinical Center for 2-3 nights for bright light treatment. They remain in their rooms for alternating periods of exposure to standard dim room light and bright light, using a light box placed within 3 to 5 feet of the child. An electroencephalogram (EEG) with additional electrodes to track eye movements is used to monitor the child s attention. Between 8AM and 6PM serial blood samples are collected to measure melatonin levels. A parent rates the child s mood and behavior during the 2-day test period. - Children are admitted to the NIH Clinical Center for 2-3 nights for melatonin treatment. They take a single dose of melatonin or placebo tablet at bedtime. During the daytime, EEG electrodes are placed to track eye movements. Between 7 PM and 7 AM serial blood samples are collected to measure melatonin levels. A parent rates the child s behavior and mood as described for the bright light study. - Children may receive either or both of the bright light and melatonin treatments. Part 2 Outpatient Trial Children participate in a combined bright light with melatonin trial at home. They undergo the same procedures outlined in the pre-trial at-home phase of Part 1 (actiwatch, behavior assessments, body temperature measurements, saliva samples) over an 11-week period. If saliva samples cannot be collected for melatonin testing, 24-hour urine samples may be collected instead.

NCT ID: NCT00359216 Completed - Clinical trials for Obstructive Sleep Apnea

The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726)

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

This is a Phase 4 randomized, placebo-controlled, parallel-group, single-center, double-blind study to evaluate the effects of mometasone furoate nasal spray (MFNS) in subjects with Sleep-disordered Breathing (SDB) associated with perennial allergic rhinitis (PAR) using Peak Nasal Inspiratory Flow (PNIF), Embletta device home-monitored cardiopulmonary evaluations, and rhinitis evaluations and questionnaires. Approximately 30 subjects 18 to 60 years of age with symptomatic PAR (with or without SAR) will be selected and randomized at one study site. The anticipated duration of subject participation in the study is approximately 39 days. Subjects who qualify at the Screening Visit will complete a 10-14 day run-in/screening period. Following the run-in period, subjects who meet the qualifications at the Baseline Visit will be treated with study medication for 4 weeks.

NCT ID: NCT00338429 Completed - Sleep Disorder Clinical Trials

Better Days, Better Nights: Treatment for Sleep Difficulties (Telephone Coached)

Sleep
Start date: April 2005
Phase: Phase 2
Study type: Interventional

The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the effectiveness of the Strongest Families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate sleep onset latency and/or bedtime resistance difficulties. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in sleep patterns (sleep onset latency and/or bedtime resistance).

NCT ID: NCT00246454 Completed - Clinical trials for Circadian Rhythm Sleep Disorder

Circadian Rhythms and Sleep in Familial DSPS and ASPS

Start date: September 2003
Phase:
Study type: Observational

The purpose of this study is to determine the properties of circadian rhythms and sleep propensity in familial advanced and delayed sleep phase syndrome (DSPS).

NCT ID: NCT00238108 Completed - Hypertension Clinical Trials

Melatonin Supplements for Improving Sleep in Individuals With Hypertension

Start date: October 2005
Phase: Phase 2
Study type: Interventional

This study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with high blood pressure who are taking beta-blockers.

NCT ID: NCT00199446 Completed - Sleep Disorder Clinical Trials

Study of Istradefylline (KW-6002) for the Treatment of Restless Legs Syndrome

Start date: July 2005
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) in patients with Restless Legs Syndrome.

NCT ID: NCT00179348 Completed - Depression Clinical Trials

Yoga-Based Rehabilitation Program in Reducing Physical and Emotional Side Effects in Patients With Cancer

Start date: February 8, 2001
Phase: N/A
Study type: Interventional

This clinical trial studies yoga-based rehabilitation in reducing physical and emotional side effects of living with cancer or its treatment. Yoga-based rehabilitation may reduce side effects and improve the quality of life of patients with breast, lung, or colorectal cancer.

NCT ID: NCT00133055 Completed - Child Behavior Clinical Trials

Parenting Matters: Helping Parents With Young Children

Start date: July 2005
Phase: Phase 2
Study type: Interventional

Sleep and discipline problems are the most common problems for parents of young children (ages 2 to 5 years old) and are the two concerns with the strongest relations to future child behavior problems. The Parenting Matters program combines treatment booklets and telephone support to help parents deal with sleep or discipline problems. Parents with concerns and who are interested in the study are identified during a visit to their family physician. We, the investigators at the University of Western Ontario, expect that parents receiving treatment booklets, along with usual care by their family physician, will have greater reductions in their child's sleep or discipline problems, improved parenting practices, and greater reductions in child behaviour problems after receiving the Parenting Matters intervention, compared to parents receiving usual medical care.

NCT ID: NCT00132821 Completed - Sleep Disorders Clinical Trials

Impact of Smoking Cessation on Sleep - 5

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

Smoking is a major health problem with a direct link to elevated heart- and lung-related problems. Nicotine is highly addictive, which makes quitting difficult and relapse after quitting highly probable. Any type of sleep disturbance may make quitting even harder. The purpose of this study is to evaluate the effect of bupropion and nicotine replacement therapies (NRT) on sleep disturbances. In turn, this might show how such medications affect attempts at smoking cessation.

NCT ID: NCT00075842 Completed - Fatigue Clinical Trials

(Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy

Start date: August 2003
Phase: Phase 3
Study type: Interventional

RATIONALE: The herb Valeriana officinalis (valerian) may promote sleep. It is not yet known whether valerian is effective in improving sleep in patients who are receiving adjuvant therapy for cancer. PURPOSE: This randomized phase III trial is studying how well valerian improves the quality of sleep in patients who are receiving adjuvant therapy (radiation therapy, chemotherapy, or hormone therapy) for cancer.