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Parasomnias clinical trials

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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: 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: NCT06145971 Recruiting - Insomnia Clinical Trials

Assessing the Impact of Brief CBTi on Dissociative Seizures: SCED

CBTi 4 DS:SCED
Start date: May 6, 2024
Phase: N/A
Study type: Interventional

Some people experience a temporary change in behaviour and consciousness, that often involves a collapse and/or shaking limb movements. These are referred to as 'Dissociative seizures'. Those who experience such seizures have been found to also display high levels of dissociation, which can be described as a change in your conscious experience and may include gaps in your memory for events. It is thought that people who experience dissociative seizures also often have difficulties with their sleep. Having difficulties with sleep may make these seizures and the amount of dissociation an individual experiences worse. Greater dissociation may be additionally linked to worsening dissociative seizures. A psychological treatment for sleep difficulties called Cognitive Behavioural Therapy for Insomnia (CBTi), has been found to be effective in reducing sleep difficulties. The main questions this study aims to answer are: 1. Does brief CBTi (bCBTi) improve sleep difficulties in those with dissociative seizures? 2. Does bCBTi reduce the frequency of dissociative seizures? 3. Does bCBTi reduce self-reported levels of dissociation in participants? 4. Does improving sleep difficulties lead to improvements in quality of life, mood and anxiety levels? 5. Is bCBTi a feasible intervention to administer in an inpatient setting? This study will investigate whether improving sleep by administering a brief version of CBTi leads to an improvement in levels of dissociation and dissociative seizure frequency. It will also investigate whether brief CBTi is a feasible treatment method for sleep difficulties in an inpatient setting. Participants who have dissociative seizures and sleep difficulties that could be diagnosed as insomnia will be randomly assigned to a baseline phase of 5, 7 or 9 days, where they will fill out daily questionnaires on their sleep, dissociation and number of seizures. They will then begin a 10-day intervention phase where they will attend two sessions of brief CBTi, whilst also completing daily measures. This will allow us to see whether their scores on the sleep and dissociation measures improve when the intervention begins. Participants will be asked to wear an Actiwatch during the night, to gather information on their movement levels during the night. Information on changes in quality of life, mood and anxiety levels following the sleep intervention will also be collected.

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.

NCT ID: NCT06108830 Recruiting - Sleep Disturbance Clinical Trials

Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients

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

To explore the effects of esketamine combined with remimazolam on postoperative sleep disturbance and anxiety in surgical patients undergoing gastroenteroscopies

NCT ID: NCT06093633 Recruiting - Sleep Disorder Clinical Trials

A Prospective Study to Evaluate the WP in Comparison to PSG in Patients Suspected of Sleep Disorders

Start date: September 19, 2022
Phase:
Study type: Observational

The current study is a prospective blinded study to collect data regarding the performance of the WP device in detecting sleep disorders. For that purpose, the WP with finger probe and chest sensor will be worn by the subject simultaneous to PSG in a sleep study at the clinical sleep lab. A PSG system will be recording the PSG data.

NCT ID: NCT06074224 Recruiting - Sleep Disturbance Clinical Trials

Sleep Assessment: The Benefits of Identifying Sleep Disturbance Using a Sleep Questionnaire

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

The investigators are interested in measuring the influence of addressing sleep in the orthopedic setting. This includes assessing patient experience measures (satisfaction with the visit, perceived empathy, communication effectiveness) as well as greater engagement in their healthcare (patient activation). The investigators will also see what factors might be associated with sleep disturbance and if addressing sleep leads to an intervention such as cognitive behavioral therapy.

NCT ID: NCT06023654 Recruiting - Cancer Clinical Trials

Identifying Circadian Rest-Activity Rhythm Disorders in Patients With Advanced Cancer

Start date: May 15, 2023
Phase:
Study type: Observational

Circadian rest-Activity Rhythm disorders (CARDs) are common in patients with cancer, particularly in advanced disease. CARDs are associated with increased symptoms, poorer quality of life, poorer response to anticancer treatments and shorter survival. The goal of this observational study is to see how common CARDs are in patients with advanced cancer and to characterise their rest and activity patterns in more detail. A recent study has outlined a standard way to assess and diagnose a CARD. This study aims to assess patients with advanced cancer for a CARD using a novel screening tool against this newly formed diagnostic criteria. Potentially modifiable risk factors will be considered along with associations between CARDs and symptoms, sleep preferences, sleep quality, daytime sleepiness, quality of life measures and predictors of survival.