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Insomnia clinical trials

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NCT ID: NCT03596879 Completed - Insomnia Clinical Trials

Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression

PPD
Start date: July 18, 2018
Phase: N/A
Study type: Interventional

The primary objective of the proposed research is to determine whether prenatal insomnia and ruminative thinking predict severity of postpartum depression (PPD) symptoms. Additionally, the investigators will also determine the effectiveness of digital/internet-based Cognitive Behavioral Therapy for Insomnia (dCBTI) in reducing the risk for PPD.

NCT ID: NCT03561064 Completed - Cancer Clinical Trials

Improving Sleep in Cancer Patients: A Feasibility Trial

ISCAP
Start date: April 13, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if CBT-I (cognitive behavioral therapy for insomnia) is a feasible treatment for insomnia in individuals undergoing cancer treatment.

NCT ID: NCT03546036 Completed - Insomnia Clinical Trials

Controlled Study of Chain Blanket for Insomnia

Start date: March 4, 2015
Phase: N/A
Study type: Interventional

The aim of the study is to compare an intervention with a weighted metal chain blanket of 8 kg with a control plastic chain blanket of 1,5 kg for patients with Major depressive disorder, bipolar disorder, Generalized Anxiety Disorder (GAD) and/or attention deficit hyperactivity disorder (ADHD) and co-occurring insomnia. Patients are evaluated by a rater blind to treatment allocation with Insomnia Severity Index (ISI), Fatigue Symptom Inventory (FSI), Hospital Anxiety and Depression Scale (HAD) and actigraphy before, during and at primary end-point after 4 weeks use of the blanket.

NCT ID: NCT03543371 Completed - Insomnia Clinical Trials

Neuropsychological Outcome After Cardiac Arrest

Start date: July 13, 2018
Phase:
Study type: Observational

This study is a sub-study to the large pragmatic Target Temperature Management 2 Trial (TTM2-trial, ClinicalTrials.gov Identifier: NCT02908308), assessing effectiveness of controlled hypothermia after out-of-hospital cardiac arrest (OHCA). This study is designed to provide detailed information on cognition after OHCA and its relationship to associated factors as emotional function, fatigue, and sleep. A secondary aim is to utilize this information to validate a neurocognitive screening battery used 6 months after OHCA in the TTM2-trial. Approximately 7 and 24 months after OHCA, survivors at selected TTM2 study sites will perform a standardized neuropsychological assessment including performance-based tests of cognition and questionnaires of behavioral and emotional function, fatigue, and insomnia. At 1:1 ratio, a control group of myocardial infarction (MI) patients but no occurrence of cardiac arrest will be recruited and perform the same test battery. Group differences at 7 and 24 months will be analyzed per cognitive domain (verbal, visual/constructive, short-term working memory, episodic memory, processing speed, executive functions). Results of the OHCA survivors on the TTM2 neurocognitive screening battery will be compared with neuropsychological test results at 7 months time.

NCT ID: NCT03542604 Completed - Breast Cancer Clinical Trials

Cancer, Obesity/Overweight and Insomnia Study

COIN
Start date: June 12, 2018
Phase: N/A
Study type: Interventional

This is a randomized pilot study to better understand the relationships among insomnia, weight loss, and breast cancer. This study will assess the effectiveness of a sleep intervention prior to a web- and phone-based weight loss program.

NCT ID: NCT03534284 Completed - Insomnia Clinical Trials

Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis

Sleep-HD
Start date: September 19, 2018
Phase: Phase 3
Study type: Interventional

Insomnia is a common and distressing symptom for patients on hemodialysis (HD), and there is evidence for a much larger impact on the health of patients. Chronic insomnia is disrupted sleep that occurs at least three nights per week and lasts at least three months. The SLEEP-HD study is a randomized open-label clinical trial to compare two types of treatment for insomnia in participants who have end-stage renal disease on HD, and who have been diagnosed with chronic insomnia. The two types of treatment involved in the study are Cognitive Behavioral Therapy for Insomnia (CBT-I) or treatment with a drug (trazodone vs placebo). 126 participants will be enrolled who are undergoing HD in two study locations (Seattle, Washington and Albuquerque, New Mexico).

NCT ID: NCT03532282 Completed - Insomnia Clinical Trials

The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy

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

This project aims to compare the effectiveness and implementation potential of two primary care friendly approaches to delivering an effective non-pharmacological intervention - cognitive behavioral therapy - for insomnia to middle aged and older adults.

NCT ID: NCT03511209 Completed - Insomnia Clinical Trials

Discontinuation of Hypnotics in Older Veterans

SWITCH
Start date: December 10, 2018
Phase: N/A
Study type: Interventional

Sleeping medications, called hypnotics, are often prescribed for insomnia. About one-quarter of Veterans use hypnotics (or bedtime alcohol). Older patients who use hypnotics fall more often and have worse memory than those who do not use them. Stopping hypnotics often reverses these problems. The Department of Veterans Affairs (VA) is trying to reduce hypnotic use among older adults. Currently, there are two main treatments to help patients stop using hypnotics. The first treatment involves a slow decrease in the daily dose until the hypnotic is ultimately discontinued. For safety, the process of decreasing the daily dose is usually supervised by a physician. The second is a treatment for insomnia called cognitive behavioral therapy for insomnia (CBTI). This study will compare a novel hypnotic tapering method to the usual tapering method offered to older Veterans. The purpose of the study is to determine if the novel tapering method is more effective than the usual tapering method, both in terms of hypnotic discontinuation and improvement in insomnia severity. Participants will be recruited from among Veterans 55 years and older who receive care from one VA Healthcare System. Following a baseline assessment, participants will be randomly assigned to one of the two 8-week treatment groups (66 participants per group). Each treatment group will receive CBTI, however, one group will receive the novel tapering program and the other group the usual tapering program. Follow-up assessments will be conducted at post-treatment and at 6-months after completion of the treatment. If the novel tapering program is effective, it will represent a treatment option that can be offered to older Veterans who want to discontinue hypnotics. This tapering program could help VA healthcare providers adhere to clinical guidelines that recommend benzodiazepine discontinuation among older adults. A reduction in chronic hypnotic use may in turn reduce the risk of falls and hip fractures, which ultimately may improve the health and quality of life of older Veterans who receive healthcare at the VA.

NCT ID: NCT03503695 Completed - Chronic Pain Clinical Trials

Auricular Acupuncture for Chronic Pain and Insomnia

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

Background: In the U.S. approximately 1.6 million adults use complementary and alternative or integrative medicine therapy for pain and insomnia. However, very few studies have tested the use of auricular acupuncture (AA) using a standard protocol for participants with chronic pain and insomnia. Objective: To assess the feasibility and acceptability of AA and to evaluate the effectiveness of AA on pain severity score, pain interference score, and insomnia over an 8-day study period. Subjects: 45 participants who met the eligibility criteria and signed the consent were randomized to either the AA group (AAG) or the usual care control group (CG) on day 4. Intervention: A standard AA protocol using penetrating semi-permanent acupuncture needles and in-place for up to four days. Main Outcome Measures: Brief Pain Inventory pain severity and interference scores for pain and Insomnia Severity Index (ISI) for insomnia. Results: The use of the standard AA protocol in the AAG led to significant within- and between-group reduction in pain severity and interference scores when compared to the CG. Both groups showed within-group decrease in ISI. However, the AAG showed significant between-group reduction in ISI severity and from moderate to sub-threshold insomnia. Conclusions: AA was found to show effectiveness in the treatment of chronic pain and insomnia. With a heightened focus on the opioid crisis in the U.S., this easy-to-administer protocol can be an option for treatment modality for military beneficiaries with chronic pain and insomnia.

NCT ID: NCT03493958 Completed - Insomnia Clinical Trials

RCT of Web-Based Behavioral Sleep Intervention for Individuals With Alcohol Use Disorder

Start date: March 5, 2019
Phase: N/A
Study type: Interventional

Background: Many people with alcohol use disorders have a sleep problem called insomnia. One treatment is Cognitive Behavioral Therapy for Insomnia (CBT-I). Researchers want to study adults experiences with a web-based CBT-I program called SHUTi. Objective: To test if a web-based insomnia therapy program works well and helps people with alcohol use disorders. Eligibility: Adults ages 18-65 who joined another protocol and have been an inpatient on that protocol at least 14 days. Design: Participants will be screened with questions about insomnia. They will wear a device on their wrist and finger for one night while sleeping. This checks for sleep apnea. Participants will complete 1 of 2 programs: 1. SHUTi: Participants will start using the program in the hospital and finish it about 6 weeks later. They will get a computer tablet to access SHUTi at least 3 times a week. They will get surveys, stories, videos, and interactive data about sleep. They will complete at least 5 daily sleep diaries every week. SHUTi will be customized based on the diaries. 2. Education-only program: This is like SHUTi but it is not interactive and is not customized. Participants will access it at least once a week. They will finish at their own pace within 6 weeks. These participants may access SHUTi later. All participants will wear a device on their wrist for 4 straight days at several different time points. It records activity and sleep data. They will do this 3 times. Participants will answer questions about the program before starting it and after finishing. Interviews will be audio recorded. Participants will do follow-up surveys 6-7 months after they are discharged from the hospital.