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Dyssomnias clinical trials

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NCT ID: NCT06194162 Recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder

Weighted Blankets for Sleep Disturbance Among Children With ADHD

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Many children with ADHD suffer from sleep disorders and dysfunction, which may affect development and well-being. According to the clinicians, some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch, muscles and joints. However, evidence for an effect on sleep is scarce, and only one RCT has investigated the effect of weighted blankets among children with ADHD. Using a RCT design, the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by (1) using a weighted blanket during night and daytime in addition to usual treatment, compared to (2) usual treatment and a non-weighted sham blanket, with the primary outcome being differences in total sleep time. Results will support health- and social professionals who are involved in the treatment of children with ADHD.

NCT ID: NCT06170073 Recruiting - Aging Clinical Trials

Hong Kong Cohort of Abnormal Sleep in Ageing Population (HK-ASAP): Focusing on Brain Health and Sleep Quality

HK-ASAP
Start date: October 1, 2023
Phase:
Study type: Observational

Poor sleep quality can significantly jeopardize the brain health, cognitive functions, daily activities, quality of life, and even be implicated as a key potential contributing factor in the development of accelerated cognitive decline and prodromal dementia. Consequently, research efforts to understand, and therefore potentially model, the effects of sleep quality on cognition and brain health are of great pragmatic values.

NCT ID: NCT06169254 Recruiting - Clinical trials for Cognitive Impairment

High-frequency Transcranial Random Noise Stimulation (Hf-tRNS) for Sleep Disturbances in Neurocognitive Disorders Due to Vascular Disease

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

The investigators aim to 1) investigate and compare the safety, efficacy and sustainability of hf-tRNS, tACS and sham transcranial current stimulation (tCS) over left inferior parietal lobe (IPL) in mild neurocognitive disorder due to vascular disease (NCD-vascular) patients with sleep disturbances; 2) examine the relationship between the changes in sleep quality, cognitive function and brain morphometry. Methods: Chinese right-handed mild NCD-AD patients with sleep disturbances (aged from 60 to 90 years) will be randomly assigned to a 2-week intervention of either hf-tRNS, tACS, or sham tCS, with 10 participants per arm. Before intervention, structural magnetic resonance imaging (MRI) data is used to construct individual realistic head model. Comprehensive assessments, including sleep quality, cognitive performance and blood pressure will be conducted at baseline, 2th week, 6th week and 12th week. Program adherence and adverse effects will be monitored throughout intervention.

NCT ID: NCT06165887 Not yet recruiting - Clinical trials for Moderate-to-severe Psoriasis

The Relationship Between Moderate-to-severe Psoriasis and Sleep Disturbance

Start date: February 2024
Phase:
Study type: Observational

Psoriasis is a common chronic and systemic immune-mediated disease, induced by a combination of genetic and environmental effects. The increasingly worrying question is the negative impact on patients' sleep, which has become an important comorbidity of psoriasis. To investigate the causal relationship between psoriasis and sleep status, a prospective cohort study will be conducted by separating moderate-to-severe psoriasis patients and healthy individuals into distinct cohorts in order to observe their sleep status.

NCT ID: NCT06156293 Recruiting - Sleep Disturbance Clinical Trials

Prevention of Insomnia Using a Stepped Care Model in Adults

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

Insomnia is one of the most common sleep disorders and affects approximately 10 - 40% of the population across different age groups in Hong Kong. Our previous study has shown that insomnia can be prevented through a brief cognitive behavioral prevention program in adolescents. However, there is very limited data in the adult population. Current study aims to evaluate a digital sleep-focused platform which consists of different intervention plan according to user's insomnia severity level and employed a stepped care model. Thus, the effectiveness of the stepped care model will be evaluated in a real world setting using stepped wedge cluster randomized controlled design to evaluate potential preventive effect on adults who only with mild insomnia symptoms. The program will be rolled out to different districts in Hong Kong sequentially in 18 districts over 4 steps with a equally spaced time periods. The primary aim of this study is to evaluate the effects of a stepped-care CBT-I model in improving sleep and prevent the incidence of insomnia among participants with mild insomnia.

NCT ID: NCT06154616 Completed - Poor Quality Sleep Clinical Trials

Efficacy of Different Types of Milk in Improving Sleep Quality in Subjects With Sleep Problems (Milca)

Milca
Start date: September 15, 2023
Phase: N/A
Study type: Interventional

Randomized, controlled, double-blind intervention study, with four parallel branches depending on the product consumed, to analyze the efficacy of different types of milks on the improvement of sleep quality.

NCT ID: NCT06147089 Recruiting - Clinical trials for Shift-Work Related Sleep Disturbance

Shift Work Intervention Strategies for Night Shift Workers

GRIP
Start date: February 9, 2023
Phase: N/A
Study type: Interventional

The goal of this intervention study is to test behavioral interventions in night shift workers. The main question it aims to answer is: • Can personalized sleep or nutrition intervention strategies help against the negative health effects of night shift work? Participants will be followed before and after the intervention. Participants will wear smart devices, do a alertness/performance test and complete questionnaires. Blood samples will be collected. Researchers will compare the intervention groups to the control group (which receives no intervention) to see if the sleep and nutrition interventions affected the health of night shift workers.

NCT ID: NCT06131034 Recruiting - Sleep Clinical Trials

Does Perioperative Music Prevent Sleep Disturbances in Hospitalized Surgical Patients

DREAMERS
Start date: August 9, 2023
Phase: N/A
Study type: Interventional

Sleep disturbances are known to be a prevalent problem in hospitalized, surgical patients, which is of importance since sleep disturbances can lead to a range of negative health outcomes. Music interventions have shown potential in improving sleep quality. Unfortunately, the studies on the effect of music on sleep in surgical patient populations are still scarce and of low quality. Therefore, the aim of this study is to study the effect of music on sleep quality in oncological, gastro-intestinal surgical patients in the form of a randomized controlled trial. Participants will be divided in 2 groups, a music group and a control group, where the music group will receive music interventions perioperatively. The researchers will compare both groups to see if there is a difference in sleep quality.

NCT ID: NCT06112756 Recruiting - Clinical trials for Sleep Disturbances Associated With Menopause

A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause

NIRVANA
Start date: November 8, 2023
Phase: Phase 2
Study type: Interventional

Researchers are looking for a better way to treat women who have sleep disturbances associated with menopause. Menopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop. Sleep disturbances, for example, frequent waking up at night, are a common and bothersome symptom associated with menopause that affects women's quality of life. The study treatment Elinzanetant (also called BAY 3427080) is under development to treat symptoms like hot flashes which are caused by hormonal changes associated with menopause. It may block the activity of a protein that has been found to contribute to sleep disturbances. The main purpose of this study is to learn how does elinzanetant affect sleep disturbances associated with menopause as measured on a sleep test called polysomnography (PSG) as compared with placebo. For this, the researchers will analyze - change in the total number of minutes a participant wakes up at night after going to sleep after 4 weeks of treatment compared to before treatment - change in the total number of minutes a participant wakes up at night after going to sleep after 12 weeks of treatment compared to before treatment - change in the participant's total time asleep while in bed after 4 and 12 weeks of treatment compared to before treatment. The study participants will be randomly (by chance) assigned to one of two treatment groups. Dependent on the group, they will take elinzanetant or placebo for 12 weeks. Each participant will be in the study for approximately 22 weeks (plus potential washout period), including a screening phase of up to 6 weeks, 12 weeks of treatment, and a follow up phase of 4 weeks after the end of treatment. 5 visits to the study site are planned. During the study, the doctors and their study team will: - take blood and urine samples - do physical examinations - check vital signs - do sleep tests - use an electronic hand-held device to record sleep quality and hot flashes at home An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

NCT ID: NCT06109363 Recruiting - Insomnia Clinical Trials

A Stepped Care Model to Deliver CBT-I in Community

Start date: October 23, 2023
Phase: N/A
Study type: Interventional

Insomnia is one of the most common sleep disorders and affects approximately 10 - 40% of the population across different age groups in Hong Kong. Cognitive behavioral therapy for insomnia (CBT-I) is the first line treatment for adult insomnia due to its comparable effect to medication in short term but is more sustainable in the long run. However, only a few sufferers have received CBT-I, due to limited accessibility, lack of trained sleep therapists, time costing and geographical limitations. To increase CBT-I accessibility, different formats of CBT-I have been proposed. Empirical evidence including ours consistently suggested that self-help digital CBT-I is effective in improving sleep while its augmentation with a guided approach could further enhance the treatment gain. Previous evidence has suggested that although self-help CBT-I could lead to positive outcomes, the drop out rate is quite high and maybe less effective for patients with comorbidity or high level of distress. Thus, a stepped-care approach to CBT-I that utilizes online self help and therapist-guided modes of delivery might be a potential way to facilitate efficient dissemination of effective insomnia treatment resources. The effectiveness of the stepped care model will be evaluated in a real world setting using stepped-wedge cluster randomized controlled design. The program will be rolled out to different districts in Hong Kong sequentially in 18 districts over 4 steps with a eqaully spaced time periods.