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Insomnia clinical trials

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NCT ID: NCT02076165 Completed - Insomnia Clinical Trials

Insomnia Treatment for Women Veterans

Start date: September 1, 2014
Phase: N/A
Study type: Interventional

Women Veterans have high rates of insomnia. Prior research and our preliminary findings show that insomnia impacts the health and quality of life of women Veterans and that those with insomnia prefer non-medication treatments over sleeping pills. This study compared two non-medication behavioral treatments for insomnia to determine impacts on adherence rates and sleep/wake patterns. A novel treatment, Acceptance and the Behavioral Changes to Treat Insomnia (ABC-I) was compared to standard treatment, Cognitive Behavioral Therapy for Insomnia (CBT-I). The results showed that ABC-I was non-inferior to CBT-I and adherence to the treatments was similar in both groups. These results improve the repertoire of available behavioral treatments for insomnia within VA by showing that a new treatment, called ABC-I, works as well as standard CBT-I.

NCT ID: NCT02058992 Completed - Insomnia Clinical Trials

Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty

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

The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia.

NCT ID: NCT02044263 Completed - Insomnia Clinical Trials

Cognitive Behavior Therapy for Insomnia Delivered by a Therapist or on the Internet

Start date: July 2014
Phase: N/A
Study type: Interventional

Background: Insomnia is a highly prevalent and disabling disorder where Cognitive Behavior Therapy for Insomnia (CBT-I) is established as the best available treatment. Still, only a negligible number of patients with insomnia receive this treatment. One potential way of improving the dissemination of CBT-I is by using online adaptations of CBT-I. This is a new method for delivering CBT-I and it is not known how effective online treatment is compared to face-to-face CBT-I. This trial's purpose is to compare face-to-face CBT-I with online CBT-I. Because of the great advantage of online treatment in both availability and cost, the trial is designed as a noninferiority trial. Aim: To test if online CBT-I is noninferior in reducing insomnia complaints compared with CBT-I as delivered face-to-face by a therapist.

NCT ID: NCT02043977 Completed - Insomnia Clinical Trials

Efficacy and Safety Study of Propofol Infusion for Refractory Chronic Primary Insomnia

Start date: June 2013
Phase: Phase 1
Study type: Interventional

Insomnia is a widespread condition in which approximately one-third of adults in the United States are symptomatic with 6% of the population meeting the diagnostic criteria for insomnia. There is an increased risk of insomnia in certain segments of the population including women, middle-aged and older adults, shift workers and individuals with medical or psychiatric disorders. Individuals with insomnia have a decreased quality of life compared to those who report other serious illnesses such as major depression and congestive heart failure. Chronic insomnia can be caused by medications, drug or alcohol abuse, psychiatric disorders, medical and neurologic disorders. It can impair cognitive and physical functioning. Propofol is an approved drug administered intravenously for use in the induction and maintenance of anesthesia or sedation. Some research suggests that propofol when administered as a two hour infusion may improve the ease of sleep onset, sleep quality, ease of awakening and the integrity of behavior following waking. This study will be conducted in the Broward Health Medical Center Sleep Lab, under the direct care of a Board Certified Anesthesiologist, dedicated to the study involving participants who have refractory chronic primary insomnia and have not responded to conventional pharmacologic therapies within the past 90 days. Each qualifying participant will receive an IV infusion of the study medication for 5 consecutive nights. Assessments including polysomnography with completion of questionnaires will occur at screening, Days 1 through 5 of study product administration, Day 6 and Day 90. Follow-up questionnaires will also be distributed on Day 180.

NCT ID: NCT02038556 Completed - Insomnia Clinical Trials

Exploring the Outcomes and Financial Impact of a CBT-I Group Program Provided by Registered Nurses for Adults With Insomnia

Start date: May 2013
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to evaluate our RN CBT-I program outcomes and determine utility of this program as a high-value care model targeted specifically to our sleep center patient population. Hypothesis: PIRS will improve from baseline to 2 month follow up

NCT ID: NCT02037438 Completed - Insomnia Clinical Trials

Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study

SMART DOCS
Start date: January 2014
Phase: N/A
Study type: Interventional

Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART DOCS) was designed to develop and evaluate a new approach (patient-centered outcomes and coordinated-care management [PCCM]) for the diagnosis and treatment of sleep disorders. Specialized and pertinent information and resources regarding sleep disorder management were developed and made available through an online portal, allowing patients to make informed health care decisions, and providers to assist patients in achieving what they feel are the most important goals regarding their care. Half of participants were randomized into the conventional diagnosis and treatment (CONV) arm and the other half into the patient-centered outcomes and coordinated-care management (PCCM) arm. Validated objective and subjective assessment measures were administered at intervals throughout a 13 month participation period in both the CONV and PCCM arms to determine whether the new PCCM approach for sleep medicine results in increased patient satisfaction, quality of care, and improved health outcomes. Qualifying participants were 18 years of age or older and presenting with a new sleep disorder. Patients received no monetary compensation.

NCT ID: NCT02027558 Completed - Insomnia Clinical Trials

Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans

Start date: January 1, 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a novel intervention combining cognitive behavioral therapy for insomnia plus a positive airway pressure (PAP) behavioral adherence program provided by allied health personnel for older Veterans with obstructive sleep apnea and comorbid insomnia improves nighttime sleep and PAP adherence.

NCT ID: NCT02001077 Completed - Fibromyalgia Clinical Trials

Sleep and Pain Interventions in Fibromyalgia

SPIN
Start date: February 2009
Phase: N/A
Study type: Interventional

This is a single-center, randomized controlled trial study design. Enrolled participants had comorbid fibromyalgia and chronic insomnia. Participants were randomized to a behavioral intervention for pain, a behavioral intervention for insomnia, or a waitlist control. The study intervention period lasted eight weeks. The objective of the study is to examine the impact of two behavioral treatments on sleep and pain and to better understand what causes chronic pain and chronic sleep disturbance.

NCT ID: NCT01988129 Completed - Clinical trials for Obstructive Sleep Apnea

Fire Fighter Fatigue Management Program: Operation Healthy Sleep

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

Firefighters work some of the most demanding schedules known under highly stressful and demanding conditions. The need to work frequent extended shifts and long work weeks leads to acute and chronic partial sleep deprivation as well as misalignment of circadian phase. Sleep disorders are common, costly, and treatable, but often remain undiagnosed and untreated and it is likely that a significant proportion of firefighters suffer from undiagnosed sleep disorders which will further impair their sleep and exacerbate fatigue.In the current proposal, we aim to address the health, performance and safety issues related to fatigue in firefighters and test the effectiveness of a Comprehensive Firefighter Fatigue Management Program (CFFMP) that we have termed 'Operation Healthy Sleep.'

NCT ID: NCT01987089 Completed - Insomnia Clinical Trials

The Efficacy of CBT-I in Alcoholics & Its Effects on Remission & Relapse

Start date: August 15, 2014
Phase: N/A
Study type: Interventional

Insomnia is a highly prevalent disorder in those recovering from alcoholism. It has been associated with anxiety and depressive symptoms, as well as an increased risk of relapse back to the drinking. Cognitive Behavioral Therapy for Insomnia (CBT-I), a non-pharmacologic approach is the recommended standard of care for insomnia. Some preliminary studies have shown that CBT-I may be efficacious for insomnia during recovery. The current study proposes to use a standard 8-week CBT-I to treat the insomnia with a post-treatment follow-up at 3- and 6-months (after treatment). Further, it will evaluate if an improvement in the insomnia is associated with an improvement in the underling alcoholism and the daytime functioning. On an exploratory basis, the association of a first-degree family history of alcoholism with the insomnia severity and treatment response will also be evaluated.