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Insomnia Chronic clinical trials

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NCT ID: NCT04406103 Completed - Insomnia Chronic Clinical Trials

Protocol - Your Answers When Needing Sleep in New Brunswick

YAWNS NB
Start date: November 6, 2020
Phase: N/A
Study type: Interventional

New Brunswick has an aging population with Canada's highest rate of sleeping pill use. The rate of long-term (chronic) use among NB seniors is 25%, well in excess of the Canadian average of 10%. The rate of use is higher in women and increases with age, as do risks for serious harms. Sleeping pills risks are substantial and costly, especially to seniors. Research does not support their long-term use. Risk for falls causing injuries, including hip fractures, is a leading concern. They impair mental and physical functioning resulting in a loss of independence and cause impaired driving and a higher rate of serious crashes. The rate of near-fatal and fatal overdoses from mixing sleeping pills with other drugs is on the rise. Stopping treatment can be difficult due to physical dependence and withdrawal symptoms. Cognitive behavioural therapy for insomnia (CBTi) is recommended as the first-line treatment of chronic insomnia. Sleeping pills are only to be considered when CBTi fails. However, these recommendations are not reflected in primary care practice. Internationally, many educational interventions targeting prescribers have been tried, yet have failed to reduce sleeping pill use. However, a 12-page pamphlet (EMPOWER) given directly to seniors in a clinical trial was associated with a large reduction in sleeping pill use. Using a similarly persuasive approach, Sleepwell (mysleepwell.ca) was developed to reduce the use of sleeping pills and facilitate CBTi access and use. Sleepwell differs from EMPOWER by providing specific information and recommendations regarding CBTi in addition to guidance on how to stop sleeping pills. This study will evaluate the effectiveness of direct-to-patient interventions on long-term sleeping pill use.

NCT ID: NCT04402021 Completed - Insomnia Chronic Clinical Trials

Exercise and Insomnia Study: The Effects of 1 Week of Exercise Training on Insomnia Severity

Insomni-Ex
Start date: August 11, 2020
Phase: N/A
Study type: Interventional

It has been hypothesized that exercise may have a beneficial effect on sleep quality and insomnia severity in those who have insomnia symptoms as well as those who meet diagnostic criteria for insomnia disorder (e.g., Diagnostic and Statistical Manual 5th edition (DSM-5)). Yet, the studies that have tested this are extremely limited in number and even fewer explore any acute effects of exercise training on subjects who meet diagnostic criteria. Thus, the investigators propose to conduct a randomized parallel design to compare the effects of short-term moderate-intensity aerobic exercise on insomnia severity and measures of sleep in a sample of adults who meet diagnostic criteria for insomnia.

NCT ID: NCT04377009 Completed - Clinical trials for Mild Traumatic Brain Injury

Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of TBI

Start date: July 7, 2020
Phase: N/A
Study type: Interventional

This study aims to validate an established internet-guided cognitive behavioral therapy for insomnia (CBT-I) as an alternative program to traditional in-person therapy that may increase treatment availability and utilization within the military health system. The version of the internet-guided CBT-I program being studied has been customized specifically for military service members. The study will assess if the customized internet-guided CBT-I program will positively improve clinical measures of insomnia and quality of life outcomes in active or retired service members with primary insomnia and associated mild traumatic brain injury.

NCT ID: NCT04253691 Completed - Pain, Chronic Clinical Trials

Sleep and Pain Intervention for Chronic Insomnia Using Virtual Reality Pilot Study

iVR
Start date: February 9, 2020
Phase: N/A
Study type: Interventional

Sleep disturbances are common among chronic pain patients, with reports typically ranging from 50-70% of patients reporting sleep difficulties. It is well documented that, alongside a high comorbidity with chronic pain, chronic insomnia also has high comorbidity with, and is a risk factor for, developing an anxiety disorders. This clinical trial will examine the effects of virtual reality (VR) meditation environments on patients with pain- and insomnia-related anxiety. The purpose of this study is to examine the benefits of using VR meditation with patients with chronic pain and chronic sleep disturbance so that clinicians can more effectively treat core causes to symptoms and reduce counterproductive therapies. Research objectives include: 1. To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in patients with chronic pain. 2. To examine changes in the primary clinical outcomes, including chronic pain, complaints of poor sleep, and fatigue. 3. To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health. 4. To examine the mechanistic variables, including arousal (heart rate variability, HRV) and CS (thermal response).

NCT ID: NCT04252638 Completed - Insomnia Chronic Clinical Trials

Acceptance and Commitment Therapy as a New Treatment for Adults With Insomnia Disorder

Start date: January 13, 2020
Phase: N/A
Study type: Interventional

Acceptance and Commitment Therapy plus sleep restriction (ACT) will be compared to Cognitive Behavioral Therapy for insomnia (CBT-I). CBT-I is the first line treatment for insomnia according to current guidelines. The aim of the study is to investigate the efficacy of ACT, compared to CBT-I, for the improvement of sleep-related quality of life and insomnia severity.

NCT ID: NCT04073992 Completed - Insomnia Chronic Clinical Trials

Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The longstanding view has been that insomnia, and other forms of sleep disturbance, emerge as a consequence of dementia and are the result of progressive neuronal damage. However, there is growing evidence that the direction of causation may go both ways, with sleep disturbance potentially increasing vulnerability to dementia. Longitudinal studies have found that sleep disturbance often precedes and increases risk for dementia by several years. The purpose of this study is to examine whether treatment of insomnia with cognitive behavioral therapy (CBT-I) is associated with a decrease in dementia biomarkers found in cerebrospinal fluid (CSF). Fifteen adults age 30-50 with chronic insomnia will undergo overnight polysomnography and CSF sampling in the morning. This will be followed by 8 weeks of treatment with CBT-I and then repeat CSF sampling.

NCT ID: NCT04024020 Completed - Insomnia Chronic Clinical Trials

Chronic Insomnia and CSF Markers of Dementia

Start date: January 1, 2019
Phase:
Study type: Observational

The longstanding view has been that insomnia, and other forms of sleep disturbance, emerge as a consequence of dementia and are the result of progressive neuronal damage. However, there is growing evidence that the direction of causation may go both ways, with sleep disturbance potentially increasing vulnerability to dementia. Longitudinal studies have found that sleep disturbance often precedes and increases risk for dementia by several years.The purpose of this study is to examine the relationship between chronic insomnia and dementia biomarkers and orexin levels found in cerebrospinal fluid (CSF). Fifteen adults age 30-50 with chronic insomnia and age- and gender-matched good sleepers will undergo overnight polysomnography and CSF sampling in the morning.

NCT ID: NCT03964974 Completed - Cannabis Use Clinical Trials

Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis

CannSleep
Start date: February 10, 2020
Phase: N/A
Study type: Interventional

As medical cannabis use becomes more common in the United States, it is essential to understand the ways in which adults who use medical cannabis perceive the benefits of cannabis use and to identify effective strategies to help them cope with these problems. Emerging data indicate that insomnia and/or use of cannabis for sleep are very common in medical cannabis patients. The present study will adapt and gather pilot data on the impact of a Cognitive Behavioral Therapy for insomnia (CBTi-CB) intervention on sleep- and cannabis-related outcomes in adults who use medical cannabis.

NCT ID: NCT03949296 Completed - Multiple Sclerosis Clinical Trials

Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis

Start date: December 11, 2017
Phase: N/A
Study type: Interventional

Purpose To determine whether Mindfulness-Based Treatment for Insomnia (MBTI) is more effective in the treatment of chronic insomnia disorder (CID) in patients with multiple sclerosis (MS) when compared with standard sleep hygiene counseling. Specific Aims / Hypotheses Our specific aims are to determine: - Whether MBTI is more effective than standard sleep hygiene counseling in improving objectively-measured sleep quality among this group of MS patients with CID, as measured by the Fitbit Charge 2 activity tracker. - Whether MBTI is more effective than standard sleep hygiene counseling in improving self-reported sleep quality among this group of MS patients with CID, as measured by the Pittsburgh Sleep Quality Index (PSQI). - Whether MTBI is more effective than standard sleep hygiene counseling in reducing self-reported severity of insomnia among this group of MS patients with CID, as measured by the Insomnia Severity Index (ISI). - Whether MBTI is more effective than standard sleep hygiene counseling in improving self-reported quality of life among this group of MS patients with CID, as measured by the Multiple Sclerosis Quality of Life Inventory (MSQLI). We hypothesize that among study participants with MS and CID: - MBTI will improve their objectively-measured sleep quality, as measured by the Fitbit Charge 2 activity tracker. - MBTI will improve their self-reported sleep quality, as measured by the PSQI. - MBTI will reduce their self-reported severity of insomnia, as measured by the ISI. - Improvement in sleep quality and reduction in insomnia severity will result in improvement in self-reported quality of life, as measured by MSQLI scores. - MBTI will be superior to sleep hygiene counseling in improving sleep quality, reducing insomnia severity, and improving quality of life.

NCT ID: NCT03774810 Completed - Insomnia Clinical Trials

Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia

R01
Start date: April 15, 2019
Phase: Phase 4
Study type: Interventional

The study is a three phase sequential study of the medical treatment of insomnia with zolpidem. All participating subjects will receive one month of standard nightly treatment. If the subject has a positive treatment response they continue in the study and are randomized to one of four conditions: intermittent dosing (3-5 pills week, full dose), or one of three variable dose conditions (nightly pill use where any given pill is a variable dose). Standard treatment will last for 4 weeks. The experimental phase will extend over two periods. The first period will last for 12 weeks. The second period will last for 36 weeks. Both periods include: • Taking a pill 30 minutes prior to bedtime. In one case, this will involve taking 3-5 pills per week. In the remaining condition pills will be taken on each and every night. Depending on the specific group that the subject is assigned to, they will either receive 10mg or 5mg of zolpidem (variable by age and sex) or a variable dose of zolpidem on a nightly basis (range from 0 mg to 10 mg per night). - Completing a sleep diary each day; - Completing 6 to 7 questionnaires each week; - A monthly visit to Penn to return your medication foil packs and to receive a new foil pack with the next month of medication. During Phases 3&4, the subject will be asked to undergo quarter annual physicals so that we can optimally track their health and wellbeing. The physicals will involve standard vitals measures (e.g., temperature, blood pressure, height and weight, etc.) and, based on the judgement of the research clinician, may involve an EKG and blood and urine chemistries. If the subject does not experience a treatment response or (following a treatment response) experiences a relapse of insomnia, they will not continue in the study but will be given the opportunity to be treated with Cognitive Behavioral Therapy for Insomnia (CBT-I) at no cost. Assessments of the subjects clinical status will be based on your daily sleep diaries and weekly questionnaires.