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Insomnia clinical trials

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NCT ID: NCT04898855 Recruiting - Cancer Clinical Trials

Internet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The main purpose of this study is to determine the treatment effects, feasibility, and acceptability of an internet-based cognitive-behavioral therapy intervention to improve the sleep of Portuguese cancer survivors with insomnia.

NCT ID: NCT04896775 Recruiting - Dementia Clinical Trials

NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers

NiteCAPP
Start date: February 2, 2022
Phase: N/A
Study type: Interventional

The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample (n of 100 caregiver and PWD dyads). We will measure both the short term (post-treatment) and long term (6 and 12 months) effects of the intervention on CG sleep, arousal, inflammation, health, mood, burden and cognitive function, and PWD sleep.

NCT ID: NCT04846010 Recruiting - Depression Clinical Trials

Recovering Damaged Cells for Sequelae Caused by COVID-19, SARS-CoV-2

sequelae
Start date: March 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Post-acute sequelae of SARS-CoV-2 infection can cause multiple system function disorders, and complicated symptoms last for an extended period. The virus can cause this continued infection, or the virus causes immune system function disorder and post-infectious autoimmune disease. The clinical symptoms can be smell loss, taste loss to liver function disorder, kidney function failure, different. No matter how complicated the systems showed in the clinic, all of the symptoms are due to the specific cells being damaged. Our clinical study is focused on recovering the damaged structure and function of the cells that could restore the organ function back to normal or close to normal

NCT ID: NCT04817163 Recruiting - Insomnia Clinical Trials

Implementation of CBT-I in Cancer Clinics

Start date: December 13, 2019
Phase: N/A
Study type: Interventional

Insomnia affects 30-60% of cancer patients, thus making it one of the most common disturbances in this population. When untreated, which is the rule rather than the exception, insomnia often becomes chronic. Chronic insomnia is associated with numerous negative consequences (e.g., increased risk for psychological disorders, health care costs). A large body of evidence supports the efficacy of cognitive-behavioral therapy for insomnia (CBT-I) in cancer patients, but CBT-I is still not offered routinely in cancer clinics. Self-administered CBT-I (e.g., video-based intervention) has been developed to increase patients' access to this treatment. However, results of clinical trials have suggested that these minimal treatments would be better used as a first step of a stepped care model. In stepped care, patients receive only the level of intervention they need. Generally, the entry level is a minimal, less costly, intervention (e.g., self-help intervention) followed by a more intensive form of treatment if needed (if the patient is still symptomatic). The investigators have recently assessed the efficacy of a stepped care model to administer CBT-I in cancer patients, which includes a web-based CBT-I (called Insomnet) followed by up to 3 sessions with a psychotherapist if the patient is still symptomatic. Results of this study suggest that this model of care is non-inferior to a standard face-to-face treatment (Savard, Ivers, et al., in revision), while being more cost-effective. A stepped care CBT-I could therefore be offered in routine cancer care clinics. This project will assess the feasibility and effectiveness of implementing a stepped care CBT-I in real-world cancer clinics, using a non-randomized stepped wedge design to compare the effects of our program (active phase) with a passive phase. The program is called Insomnia in Patients with Cancer - Personalized Treatment (IMPACT). The stepped care CBT-I (active intervention) is being implemented sequentially in the four participating hospitals over a number of equally spaced time periods of 4 months (wedges), for a total of 5 time points, over a period of 20 months.

NCT ID: NCT04700098 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation

Start date: February 14, 2022
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in Veterans with chronic obstructive pulmonary disease (COPD) and insomnia receiving an Internet-based behavioral treatment for insomnia versus online insomnia patient education. Participants will undergo a sleep and health assessment that will be performed at baseline, post-treatment, and 3-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia or online insomnia patient education.

NCT ID: NCT04693182 Recruiting - Insomnia Clinical Trials

Health Promoting Work Schedules: The Effect of Abolishing Quick Returns

HeWoS
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Introduction In shift work, quick returns refer to transitions between two shifts with less than 11 hours available rest time. Twenty-three per cent of employees in European countries reported having quick returns. Quick returns are related to short sleep duration, fatigue, sleepiness, work-related accidents, and sickness absence. The present study is the first randomized controlled trial (RCT) to investigate the effect of a work schedule without quick returns for six months, compared to a work schedule that maintains quick returns during the same time frame. Methods and analysis A parallel-group cluster RCT in a target sample of more than 4000 healthcare workers at Haukeland University Hospital in Norway will be conducted. More than 70 hospital units will be assessed for eligibility and randomized to a work schedule without quick returns for six months or continue with a schedule that maintains quick returns. The primary outcome is objective records of sickness absence; secondary outcomes are questionnaire data (n ≈ 4000 invited) on sleep and functioning, physical and psychological health, work-related accidents, and turnover intention. For a subsample, sleep diaries and objective sleep registrations with radar technology (n ≈ 50) will be collected. Ethics and dissemination The study protocol was approved by the Regional Committee for Medical and Health Research Ethics in Western Norway (2020/200386). Findings from the trial will be disseminated in peer-reviewed journals and presented at national and international conferences. Exploratory analyses of potential mediators and moderators will be reported. User-friendly outputs will be disseminated to relevant stakeholders, unions and other relevant societal groups.

NCT ID: NCT04667429 Recruiting - Insomnia Clinical Trials

the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets

Start date: January 18, 2021
Phase: Phase 1
Study type: Interventional

Multiple Dose Safety, Tolerability, PK ,PD and Food Effect Study of HEC83518 in Healthy Subjects

NCT ID: NCT04653155 Recruiting - Insomnia Clinical Trials

Cognitive Behavioural Therapy for Insomnia for Chinese Adults: a RCT

CBTI
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Background: Insomnia is a common mental problem, where people experienced difficulty falling asleep, problem maintaining asleep and early morning awakening. It is highly prevalent world-wide and in Hong Kong, causing significant suffering and distress. While evidence based intervention exists, e.g. cognitive-behavioural therapy (CBT), there will not enough therapists to meet treatment demand. A more efficient delivery of treatment, e.g. internet based therapy is called for that can delivery treatment more cost efficiently by requiring lesser therapist time. Objective: This study aims at evaluating the effectiveness of CBTi (Gp) on treating Chinese insomniac adults in Hong Kong. There has been criticism that most clinical trials have been conducted with Caucasians in Western countries and little has been done with ethnic minorities, including Asians in these countries, not to mention Asians in Asian countries, e.g., Chinese in Hong Kong. Design: A two-arm parallel-group randomised controlled trial, comparing the treatment and waitlist group Method: A CBTi protocol would be developed. Approximately 60 Chinese adults with insomnia will be recruited in Hong Kong and randomised into one of the two groups (treatment vs. waitlist). The treatment last for 6 weeks, plus a 3-month follow-up period. The primary outcome measure will be Insomnia Severity Index (ISI).

NCT ID: NCT04649281 Recruiting - Chronic Pain Clinical Trials

Insomnia and Sleep Disturbances in Chronic Pain Patients - Relation to Physical Activity Level and Opioid Use

Start date: October 12, 2020
Phase: N/A
Study type: Interventional

Pain is one of the most common causes of healthcare contact and long-term sick leave, with negative consequences on physical and mental health. Poor sleep is common in chronic pain patients. Epidemiological studies indicate that 5-7% of patients with chronic pain are treated regularly with strong opioids. Negative side effects of pain modulating drugs on sleep quality have been reported, which may have negative influence on overall disease management in chronic pain patients. However, to date there are conflicting results regarding the effects of opioids on sleep, since the pain relieving effect of opioids seem to affect sleep positively. There is data suggesting that physical activity has positive effects on both pain perception and sleep quality (and duration). The aim of the study is to explore insomnia and characteristics of sleep in patients with chronic pain and the relationship with physical activity level and opioid use.

NCT ID: NCT04646200 Recruiting - Insomnia Clinical Trials

CBT-I to Improve Functional Outcomes in Veterans With Psychosis

CBT-I Merit
Start date: November 29, 2021
Phase: N/A
Study type: Interventional

The goal of this project is to examine the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) for improving sleep and related functional outcomes in Veterans with psychosis and insomnia.