Treatment Trials

12 Clinical Trials for Various Conditions

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WITHDRAWN
Sleep Application Diary and Sleep Hygiene in Adolescents
Description

The purpose of this study will be to see if adolescents can advance bedtime above what can be accomplished by counseling alone simply by inputting their information into a sleep application diary and reporting this information back to their sleep doctor.

Conditions
RECRUITING
Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)
Description

This randomized controlled trial will evaluate the impact of an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention on sleep and the extent to which it contributes to cognitive health in individuals with mild cognitive impairment. Participants with insomnia who meet the study criteria for mild cognitive impairment will be recruited to determine the effects of the CBT-I intervention compared to a patient education condition on sleep and cognition. Internet-based recruitment methods will be used, and outcomes include sleep variables, daytime variables, and cognitive status.

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

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.

COMPLETED
Intensive Care Unit (ICU) Sleep Quality and Neurocognitive Performance
Description

The purpose of this study is to understand patients' neurocognitive performance shortly after discharge from the Medical Intensive Care Unit (MICU) and the potential effect of sleep quality in the MICU on those neurocognitive outcomes. The investigators hypothesize that post-ICU neurocognitive function and patient overall ICU sleep experience will improve through a pre-existing MICU sleep improvement initiative.

COMPLETED
Sleep Disturbance and Bipolar Disorder
Description

The study aims to evaluate a psychological intervention for individuals who suffer from sleep disturbance and bipolar disorder. We are hoping that this treatment will: (1) improve the quality of life of individuals with bipolar disorder who are suffering from sleep disturbance and (2) reduce the risk of, or help prevent, episodes.

ACTIVE_NOT_RECRUITING
Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms
Description

Breast Cancer is the most common cancer in women. After completion of successful therapy, may behavioral symptoms persist with over 20% of breast cancer survivors reporting chronic insomnia of greater than 6 months duration that fulfils clinical diagnostic criteria with associated functional limitations, decreased quality of life, and possible effects on long-term survival. Behavioral interventions are highly efficacious in the treatment of insomnia and preferred over hypnotic medication when insomnia is chronic. However, insomnia studies conducted in cancer are scarce. The proposed research builds upon program of study that has examined the efficacy of mind-body intervention, Tai Chi Chih (TCC), on health outcomes including sleep impairments. Preliminary studies show that TTC, a slow moving meditation, contributes to improvement in subjective sleep quality, sleep amounts and sleep efficiency. The investigators have further found that sleep, fatigue and proinflammatory cytokine activity are reciprocally related and that TCC decreases the mechanism through TCC carries its effects on sleep outcomes.

COMPLETED
Study of Melatonin: Sleep Problems in Alzheimer's Disease
Description

This protocol is a multicenter clinical trial of melatonin for sleep disturbances associated with Alzheimer's disease (AD). Frequent nocturnal awakening is a common behavioral symptom of AD. Nighttime wandering and agitated behavior may result in injuries and sleep disruption for caregivers. Alternatives are sorely needed to the currently available sleep medications that have marginal efficacy and serious side effects. Melatonin is a naturally occurring hormone secreted by the pineal gland. It has soporific effects with oral administration and is well tolerated. It enhances sleep in normal older people. Melatonin also may help sleep disturbances associated with AD; however, this remains to be proven.

RECRUITING
Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
Description

The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in children with Hypotonic Upper Airway Obstruction (HUAO).

COMPLETED
Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder
Description

The purpose of this study is to evaluate the maintenance effect and safety of 20 mg tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder.

COMPLETED
Tasimelteon for the Treatment of Non-24-hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception
Description

The purpose of this study is to evaluate the safety of tasimelteon in male and female patients who suffer from Non-24-Hour Sleep-Wake Disorder.

COMPLETED
Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder
Description

The purpose of this study is to evaluate the efficacy and safety of a six month double-mask treatment of tasimelteon or placebo in male and female subjects with Non-24-Hour Sleep-Wake Disorder

COMPLETED
Placebo-Controlled, Double-Blind, Study to Determine the Safety and Efficacy of SDX in Patients With IH
Description

This is a study of the safety, efficacy and pharmacokinetics (PK) of Serdexmethylphenidate (SDX) compared to placebo in subjects with Idiopathic Hypersomnia (IH).