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Sleep Disorders clinical trials

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NCT ID: NCT01286233 Active, not recruiting - Breast Cancer Clinical Trials

Study of Biomarkers Associated With Fatigue in Patients With Early-Stage Breast Cancer Treated With Metformin or Placebo on NCIC-CTG-MA.32

Start date: July 2011
Phase: N/A
Study type: Observational

RATIONALE: Studying samples of blood in the laboratory from patients with breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to fatigue. PURPOSE: This research study is studying biomarkers associated with fatigue in patients with early-stage breast cancer treated with metformin or placebo on NCIC-CTG-MA.32.

NCT ID: NCT01280097 Completed - Delirium Clinical Trials

Study of Sleep and Delirium in the Intensive Care Unit (ICU)

SID
Start date: December 2010
Phase: N/A
Study type: Observational

The investigators will perform a prospective, cohort study of 100 older intensive care unit (ICU) patients, to investigate the association between sleep disruption and ICU delirium.

NCT ID: NCT01259401 Completed - Insomnia Clinical Trials

Treating Sleep Problems in VA Adult Day Health Care

HERO-ADHC
Start date: November 2010
Phase: N/A
Study type: Interventional

The Veterans Millennium Health Care and Benefits Act (Millennium Act) of 1999 mandated the Department of Veterans Affairs (VA) to provide non-institutional long-term care to veterans. Adult Day Health Care (ADHC) is a key component of that spectrum of long-term care services. Veterans in ADHC commonly suffer from limited poor functioning, depression, cognitive problems and low quality of life. These factors can lead to continued deterioration in functioning, loss of independence, hospitalizations, nursing home placement and death. Sleep disruption is associated with depression, low quality of life, functional decline, nursing home placement, and death among older people. Sleep disturbance is common among ADHC patients, it is not addressed within routine clinical care, and treatment may be limited to medications. Studies show that untreated insomnia and medications for insomnia can increase risk of falls and other health events among older persons. On the other hand, non-medication treatments for sleep do not show these problems. These treatments have been shown to be effective in other studies. The goal of this study is to test non-medication treatments to improve sleep among older Veterans with insomnia in a VA ADHC program. The study design will facilitate translation into routine care and application in other similar VA programs.

NCT ID: NCT01256983 Completed - Sleep Disorders Clinical Trials

Light for Renal Transplant Recipients Having a Sleep-Wake Dysregulation

SleepTx-1
Start date: October 2010
Phase: Phase 0
Study type: Interventional

Sleep-wake dysregulation is a disturbance in the roughly 24-hour cycle of the circadian rhythm. Well known disorders presenting a sleep-wake dysregulation are seasonal affective disorder, jet lag and shift work. These people experience a serious mood change when the seasons change. When the day-night rhythm is desynchronized, they have sleep disturbances, little energy, and often feel depressed. An established intervention to treat this disorder is bright light therapy. Light therapy is used for affective disorders for shift workers, jet lag symptomatology and for advancing or delaying desynchronized rhythms.Two proxy measures for sleep-wake dysregulation are sleep quality and daytime sleepiness. It is known from cross sectional studies that renal transplant (RTx) recipients have a prevalence between 30% to 62% of poor sleep quality measured by self report; a prevalence of impaired daytime functioning of 34% 12 and a prevalence of depressive symptomatology of 20% to 22%. Sleep-wake dysregulation in other chronically ill population are a risk factor for morbidity and mortality. RTx nurses in the follow-up care are in the frontline for recipient's symptoms respectively problems. The psychosocial variables that should be addressed, having an association with morbidity and mortality are sleep, daytime functioning, adherence to immunosuppressive medication, exercise, smoking and depressive symptomatology. In the following research project we will address the following gaps: the fact that nature of sleep disturbances in RTx recipients has never been assessed, that there is no prevalence available on sleep-wake dysregulation and that there is no data on bright light therapy intervention in RTx recipients. Hypothesis: Renal transplant recipients having a sleep wake disregulation will have an improved sleep quality and less daytime sleepiness after 21 days of light therapy.

NCT ID: NCT01234675 Completed - Fibromyalgia Clinical Trials

The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia

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

Fibromyalgia is a condition of chronic widespread pain, sleep disturbance and fatigue. Most of the patients with fibromyalgia complain of either non-restorative sleep or complaints of disturbed sleep due to pain. The study aimed at examining the effects of milnacipran on sleep disturbance in patients with fibromyalgia. The study is a randomized, double-blind, placebo controlled, two way crossover polysomnography (PSG) study to explore the effects of milnacipran on sleep disturbance. Patients received either milnacipran 50 mg twice a day (BID) or matching placebo.

NCT ID: NCT01220401 Completed - PTSD Clinical Trials

Efficacy of a Brief Nightmare Treatment for Veterans

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

The purpose of this study is to find out what effects Exposure, Rescripting, and Relaxation Therapy (ERRT) has on nightmares and associated problems in veterans.

NCT ID: NCT01184235 Completed - Mood Disorders Clinical Trials

Multidimensional Measurement of Psychopharmacological Treatment Response

Start date: August 2010
Phase: N/A
Study type: Observational

The study examines actigraphic, observational, psychometric and associated repeated measurements obtained prior to and during psychopharmacological treatment.

NCT ID: NCT01164592 Completed - Heart Failure Clinical Trials

Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation

MS
Start date: August 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess changes in left ventricular performance using echocardiography as well as ventricular remodelling, changes in sleep and changes in mood, anxiety and cognitive functions occurring as a result of treatment of predominant central sleep apnoea by adaptive servoventilation (ASV) in chronic heart failure in addition to optimal medical therapy in chronic heart failure. This will be a substudy of the SERVE-HF study.

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.