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Insomnia, Primary clinical trials

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NCT ID: NCT06281756 Recruiting - Insomnia Clinical Trials

Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia

Start date: March 14, 2024
Phase: Early Phase 1
Study type: Interventional

Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.

NCT ID: NCT06041581 Enrolling by invitation - Stroke Clinical Trials

SHADES Mechanistic Trial

SHADES
Start date: April 25, 2024
Phase: N/A
Study type: Interventional

Cardiovascular disease (CVD) is common, deadly, and costly, and adults with insomnia represent a large group of people at elevated risk of developing CVD in the future. This clinical trial will determine if our updated insomnia treatment, called the SHADES intervention, improves CVD factors thought to explain how insomnia promotes CVD and if these improvements are due to positive changes in sleep factors. A total of 200 primary care patients with insomnia and CVD risk factors will be randomized to 6 months of the SHADES intervention (internet, telephonic, and/or face-to-face cognitive-behavioral therapy for insomnia) or the active control condition (sleep education/hygiene, symptom monitoring, and primary care for insomnia). Before and after treatment, participants will complete measurements of the CVD factors (systemic inflammation, autonomic dysfunction, metabolic dysregulation, proinflammatory gene expression) and the sleep factors (insomnia symptoms, sleep onset latency, wake after sleep onset, sleep efficiency). Researchers will test whether the SHADES intervention produces greater improvements in the CVD factors than the active control condition.

NCT ID: NCT04953559 Recruiting - Insomnia, Primary Clinical Trials

Transcranial Magnetic Stimulation of the Default Mode Network to Improve Sleep

Start date: August 6, 2021
Phase: N/A
Study type: Interventional

Insomnia is generally believed to be caused by excessive arousal of the brain and body. Rather than transitioning normally and quickly from wakefulness to sleep, individuals with insomnia tend to enter into a self-perpetuating cycle of self-referential thought and arousal. Brain imaging research has shown that these same internally focused self-reflective thoughts tend to activate a core system in the brain known as the Default Mode Network (DMN). The DMN is usually active when a person is internally focused, such as during daydreaming or mind wandering, but tends to be deactivated when the brain is focused on the external environment. The investigators hypothesize that excess activation and connectivity of this brain network may perpetuate internal conversations, worry, and rumination, preventing individuals with insomnia from falling asleep quickly and remaining asleep. Therefore, the goal of the present study is to use a brain stimulation technique known as transcranial magnetic stimulation (TMS) to target the DMN and slightly reduce its activation before bed. This should result in an easier time falling asleep. For this study, the investigators will recruit 20 healthy individuals and have them sleep in the lab on two occasions. On one occasion, they will be stimulated with a type of TMS called continuous theta burst stimulation (cTBS), which will be targeted toward their DMN. They will then try to sleep in the lab while the investigators record their brain waves using a technique known as polysomnography (PSG). On the other occasion, these same individuals will undergo the same procedure, but the TMS machine will be in a deactivated mode to present a "sham" stimulation. Participants will again try to sleep in the lab following the sham treatment while being recorded with PSG. Neither the participants nor the experimenters will know which condition the participant is receiving at the time. This will only be revealed later. Additionally, all participants will receive a brain scan just before and just after the TMS procedures so that the investigators can examine changes in brain connectivity and chemistry. The investigators expect that the participants will sleep better following the cTBS than following the sham condition and that this will be associated with measurable differences in their brain connectivity and brain chemistry. If effective, this project would have identified an innovative and novel approach for improving sleep without using drugs.

NCT ID: NCT04940975 Completed - Insomnia Clinical Trials

Occupation-based Sleep Program for People With Insomnia

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

Introduction. Sleep problems are a health issue worldwide. Based on the Person-Environment-Occupation-Performance model and the theory of occupational balance, we developed an occupation-based sleep program to address several objectives by lifestyle intervention: 1) minimize the influence of bodily function on sleep; 2) promote an environment conductive to sleep; and 3) restructure daytime activity with a focus on occupational balance through psychoeducation and lifestyle coaching. Method. This study aims to evaluate the effectiveness of an occupation-based sleep intervention on sleep pattern, mood, and occupational balance among community-dwelling adults with insomnia when compared with other, more usual, forms of treatment, typically focused on education, sleep hygiene, and relaxation. A total of 42 subjects were recruited: 22 for the intervention group and 20 for the treatment as usual group.

NCT ID: NCT04806009 Not yet recruiting - Insomnia, Primary Clinical Trials

Evaluating an Online Mindfulness-Based Intervention for Insomnia

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Insomnia has significantly negative impact on work, quality of life, psycho-somatic health on individuals and imposes substantial economic burdens on society. Mindfulness-based interventions (MBIs) have shown its efficacy in the treatment of insomnia, however the effect of online MBIs need more studies to verify. This study aims to compare the effectiveness of an online MBI named 'Mindful Living With Insomnia (MLWI)' to online CBI-I for insomnia.

NCT ID: NCT04719143 Completed - Depression Clinical Trials

Effects of Insomnia Treatment on Metabolism in Patients With Depression

Start date: December 20, 2018
Phase: N/A
Study type: Interventional

This project will examine changes in metabolism and depressive symptoms after receiving CBT-I in 30 subjects with insomnia disorder and MDD.

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: NCT04227587 Completed - Insomnia, Primary Clinical Trials

Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia Disorder

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

This randomized controlled trial (RCT) with a longitudinal mixed-method process evaluation aims to (1) determine the effectiveness of a ZTEx intervention program, which is a lifestyle-integrated physical activity program, on sleep and related outcomes in inactive adults with insomnia disorder

NCT ID: NCT04227574 Completed - Insomnia, Primary Clinical Trials

Effects of Messaging App Reminder on the Compliance of Zero-Time Exercise (ZTEx)

Start date: January 31, 2020
Phase: N/A
Study type: Interventional

This is a proof-of-concept pilot nested in the RCT titled, 'Zero-time Exercise on Inactive Adults With Insomnia Disorder'. It aims to evaluate the effects of a simple WhatsApp intervention on exercise adherence and on sleep and related outcomes.

NCT ID: NCT03322774 Active, not recruiting - Clinical trials for Major Depressive Disorder

Sleep To Reduce Incident Depression Effectively

STRIDE
Start date: March 9, 2018
Phase: N/A
Study type: Interventional

This project will assess the effectiveness of a stepped-care model (i.e. digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) followed by face-to-face CBT-I) in improving severity of insomnia and sleep outcomes in an insomnia cohort. This project will also investigate the effectiveness of this stepped-care model in prevention of major depressive disorder, and will test rumination as a mediator of treatment response.