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Insomnia Chronic clinical trials

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NCT ID: NCT05797324 Recruiting - Insomnia Chronic Clinical Trials

Light Therapy in Modulating the Clinical Phenotype of Patients With Primary and Comorbid Chronic Insomnia.

Luminoterapia
Start date: November 17, 2020
Phase: N/A
Study type: Interventional

Some evidence indicates that circadian rhythm may play a role in the pathophysiology of insomnia disorder. This single-blind randomized controlled multicentre prospective study aims to evaluate the possible therapeutic effect of light therapy in modulating the clinical phenotype of patients affected by chronic primary and comorbid insomnia, through the modification of the circadian phase.

NCT ID: NCT05745519 Completed - Clinical trials for Heart Rate Variability

Discussion on Pulse Diagnosis and Heart Rhythm Variability of Patients With Chronic Insomnia

Start date: January 1, 2022
Phase:
Study type: Observational

Discuss the objective assessment of patients with insomnia by pulse diagnosis, and measure by subjective questionnaire and physiological instruments.

NCT ID: NCT05700643 Active, not recruiting - Inflammation Clinical Trials

Montmorency Cherry Supplementation, Sleep, and Inflammation

Start date: February 18, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study will test the effects of Montmorency cherry supplementation on sleep outcomes and inflammatory biomarkers.

NCT ID: NCT05561829 Active, not recruiting - Insomnia Chronic Clinical Trials

Determination of Optimal Sleep Treatment Elements - MOST

DOSE
Start date: September 8, 2022
Phase: N/A
Study type: Interventional

Previous research has shown the efficacy of (combinations of) individual components of cognitive behavioral therapy for insomnia (CBT-I), namely sleep hygiene education, sleep restriction, stimulus control therapy, deactivation/relaxation training, and cognitive therapy. However, their relative effects, i.e., their effects in direct comparison with each other, are yet to be assessed. By means of the Multiphase Optimization Strategy (MOST), this study aims to investigate the components' relative efficacy in order to identify the most effective component or combination of components for digitized treatment of chronic insomnia. A future study will verify this intervention's effect in a randomized controlled trial (RCT).

NCT ID: NCT05561790 Completed - Insomnia Chronic Clinical Trials

Determination of Optimal Sleep Treatment Elements - Pilot

DOSE
Start date: September 6, 2022
Phase: N/A
Study type: Interventional

Previous research has shown the efficacy of (combinations of) individual components of cognitive behavioral therapy for insomnia (CBT-I), namely sleep hygiene education, sleep optimization, stimulus control therapy, deactivation/relaxation training, and cognitive therapy. However, their relative effects, i.e., their effects in direct comparison with each other, are yet to be assessed. In this pilot study, a smartphone and web application developed to treat insomnia using these treatment components will be tested. Two future studies will investigate the components' relative efficacy in order to identify the most effective component or combination of components for digitized treatment of chronic insomnia by means of the Multiphase Optimization Strategy (MOST), and verify this intervention's effect in a randomized controlled trial (RCT).

NCT ID: NCT05379244 Completed - Anxiety Disorders Clinical Trials

Better Sleep in Psychiatric Care - Depression, Anxiety and Trauma, Pilot Study

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

Between 50-80 percent of patients in psychiatry have insomnia-type sleep problems. In addition to reduced quality of life and impaired function, sleep problems can aggravate other psychiatric problems and increase the risk of relapse into, for example, depression. According to international guidelines, cognitive behavioral therapy for insomnia (CBT-i) should be used as the first choice for treatment of insomnia. In practice, however, it is very uncommon for psychiatric patients to be offered CBT-i, instead most are treated with sleep medications. There is also a lack of research studies evaluating CBT-i in regular clinical practice. This pilot study investigated the feasibility of a group treatment with CBT-i at a psychiatric outpatient clinic in Stockholm for patients with depression, bipolar disorder II, anxiety syndrome and PTSD. Changes in symptoms of insomnia, depression, and anxiety after treatment were also investigated. Patients with self-perceived sleep problems were offered a six-session group treatment based on CBT-i. The primary outcome was clinical feasibility, defined as: the influx of patients sufficient to start at least one group per semester (at least 8 patients); at least half of included patients participate in the first session; patients participate in at least half of the sessions; less than half of the patients drop out of treatment; group leaders find the treatment manual credible, easy to use and want to continue working with it after the study is completed. Secondary outcomes were changes in insomnia symptoms, and changes in symptoms of depression and anxiety.

NCT ID: NCT05373537 Recruiting - Clinical trials for Autism Spectrum Disorder

Treatment to Improve Sleep in Caregivers With Insomnia and a Child With Autism

Start date: November 5, 2022
Phase: N/A
Study type: Interventional

Autism Spectrum Disorder (ASD) represents one of the most perplexing neurobiological disorders with a prevalence of 1 in 54 children. The lifelong challenging and disruptive behaviors often associated with ASD requires caregivers to change their behavior and modify their environments to provide an ecosystem for optimal outcomes for their child, family and themselves. ASD behaviors can have significant impact on caregivers mental health and family functioning, including the ability to develop and maintain healthy sleep routines. The caregiving population in US has a high prevalence of insomnia; two thirds of caregivers experiencing difficulties falling and/or staying asleep. The prevalence of insomnia in children with ASD is equally high, 60-80% experiencing night waking contributing to poor daytime behavior and disrupted sleep in the caregivers. This pilot RCT will focus on improving caregivers sleep in the context of caring for a child with ASD and insomnia with a multi-disciplinary team. The investigators will compare a home-based tailored CBT for Insomnia (CBT-I) versus a web-based Way to Health CBT-I intervention. This data will support a larger RCT with the Department of Defense funding opportunity through the Congressionally Directed Medical Research Program. This Autism Research Program focuses on improving lives of those living with ASD.

NCT ID: NCT05277038 Completed - Pain, Chronic Clinical Trials

Clonidine is Better Than Zopiclone for Insomnia Treatment in Chronic Pain Patients

Start date: March 1, 2022
Phase:
Study type: Observational [Patient Registry]

A prospective observational crossover study of 160 consenting adult patients who underwent pain management. For insomnia treatment, each patient ingested different prescribed doses of Zopiclone or Clonidine on alternate nights. Each patient used a special validated sleep diary to collect data including pain score, sleep scores, sleep duration, sleep medication dose, and adverse effects. Each patient completed the diary for 3 continuous weeks. Pain was measured using the numeric pain rating scale. Sleep score was measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points was considered significant.

NCT ID: NCT05244889 Recruiting - Migraine Disorders Clinical Trials

Digital CBTI for Comorbid Insomnia in Chronic Migraine

Start date: January 31, 2022
Phase: N/A
Study type: Interventional

The overall aims of the study are: Aim 1: Estimate effect sizes: To estimate the effects of dCBT-I on insomnia symptoms compared to a control group (sleep hygiene education) and estimate the relationship between changes in insomnia symptoms and the reduction in migraines. Aim 2: Explore mechanisms of change: To explore the mechanisms underlining the change in migraine symptoms. Aim 3: Assess barriers to conducting a full-scale RCT: To collect data on recruitment pace and dropouts in both groups, which will help refine the methodology and maximise uptake and retention of a full-scale randomised control trial (RCT). The investigators will conduct qualitative interviews with a select number of participants and practitioners to identify motivators/barriers in uptake of a digitalised version of CBT-I.

NCT ID: NCT05078112 Completed - Insomnia Chronic Clinical Trials

Sleep Device Testing

Start date: October 20, 2021
Phase: N/A
Study type: Interventional

Infants often have sleep challenges. Most of these challenges in otherwise healthy children and due to behavioral insomnia. The goal for infants is to become independent sleepers by learning the process of self-soothing. This study hopes to determine if technology based on sensors is able to help teach self-soothing to infants.