Sleep and Circadian Problems

\# Brief Summary This clinical research study looks at whether stellate ganglion block (SGB) can improve sleep quality for people with depression. Poor sleep often goes together with depression. Medicines used for these conditions may cause side-effects or dependency. Researchers want to learn if SGB, a minimally-invasive nerve treatment, can help sleep and mood without those medicine-related downsides. This study uses a self-controlled design. Every person who joins will receive the study treatment. No separate comparison group is enrolled. Researchers will collect sleep data from each participant before treatment and again after treatment, then compare these two sets of information. About 42 participants will take part in this study. Key requirements to join the study: * Aged 18 to 65 years old * Have depression-related symptoms and sleep trouble * Able to understand and sign an informed consent form * No medical conditions that make SGB unsafe * Have not taken sleep-affecting medicines or received other sleep-focused treatments in the past one month * Can follow study schedules and complete all study assessments People cannot join if they: * Are younger than 18 years or older than 65 years * Are pregnant or breastfeeding * Have known allergies to study-used medicines * Have unstable serious organ diseases, uncontrolled substance or alcohol dependence * Cannot keep fixed daily routines or finish all study visits Study procedures for each participant: 1. On study day zero (D0): Study staff will explain the study fully. Participants will sign informed consent. Staff will run physical checks and blood tests. Participants will fill out several simple questionnaires about mood and sleep. Sleep will be measured overnight with a multi-channel sleep recording device called polysomnography (PSG). Participants also keep a short sleep diary. 2. From study day one (D1) to day five (D5): Participants get one SGB treatment each day, for a total of five treatments. During SGB, a doctor uses ultrasound guidance to inject small-dose local anesthetic near nerves in the neck. Participants keep completing their sleep diary every day. Study staff watch for any unwanted reactions during each treatment. 3. On the night of D5 through early morning of D6: PSG sleep recording will be repeated after the final SGB treatment. 4. On study day six (D6): Participants finish the final set of mood-and-sleep questionnaires. Study staff collect all safety information. Researchers will compare sleep measurements taken before treatment versus after five-day SGB treatment. Collected data includes objective sleep readings from PSG and self-reported sleep information from sleep diaries. Questionnaires will show changes in depression and insomnia symptoms. Possible benefits: SGB may make participants' sleep better and may ease depression-related symptoms. No benefit is guaranteed for every participant. Possible risks: SGB is generally safe. Rare unwanted reactions may include temporary hoarseness, local neck-site infection, or drug allergic responses. Study doctors will watch participants closely. If serious problems happen, immediate medical help will be provided. All participants' private personal information will be protected. Participants can choose to stop taking part in this research at any time without penalty.

This is an observational clinical study. It does not give new treatments to participants. Researchers want to learn how sleep gets better or worse after laparoscopic gallbladder removal surgery. Sleep problems are common after surgery. Some people may recover their sleep faster than others. Researchers will look at whether sleep recovery differs between women and men. They will also check how sex-related hormone levels connect with sleep changes. About 58 participants will join this study. Key requirements to take part: * Aged 18 to 65 years old * Scheduled for laparoscopic gallbladder removal under general anesthesia * Able to give informed consent and finish all study tasks * Can tolerate repeated blood draws * No long-term sleep-affecting medicine use in the past one month * Major organs work normally People cannot join if they: * Are younger than 18 years or older than 65 years * Are pregnant or breastfeeding * Have mental health or cognitive conditions that stop study participation * Have problems that make repeated blood collection unsafe * Have severe organ diseases or recent major injury or surgery * Have alcohol or drug dependence What happens for each participant: 1. Before surgery: Participants sign consent forms. Staff collect basic health information. Participants wear a sleep-recording device called polysomnography (PSG) overnight. Participants fill out a short sleep diary each morning. Fasting blood samples are collected the next morning to measure hormone levels. 2. On surgery day: Standard hospital care goes forward. Staff record surgery-related information. PSG sleep recording, sleep diary, and morning blood draw are repeated. 3. First and second days after surgery: The same sleep recording, sleep diary, and morning fasting blood collection continue for two more nights. Researchers compare sleep measurements across four nights. These measurements come from both PSG machine readings and participants' self-reported sleep diaries. Researchers also compare hormone level changes between female and male participants. Possible benefits: Participants receive objective feedback on their own sleep and hormone results. If test values show clear concerns, researchers share these findings with their clinical care team. No direct treatment benefit is guaranteed. Possible risks: This is a low-risk study. Small risks may include mild pain, bruising at blood draw sites, or temporary light-headedness from blood collection. Filling out short diaries may bring minor tiredness. All personal data will be kept private. Participants can leave the study at any time with no penalty.

This observational, prospective, within-subject study will examine how the volume and timing of physiotherapy and psychology classes and exams at LUDES Institute influence mental fatigue, sleepiness, motivation, executive function, and physical performance in university students. Approximately 30 students aged 18 years or older will complete repeated assessments at baseline (no formal academic activities), during a regular theoretical class, and, when feasible, during an exam session. At each time point, participants will undergo non-invasive measurements including self-reported mental fatigue (visual analogue scale), sleepiness (Karolinska Sleepiness Scale), motivation (Motivational States Scale), cognitive performance (Encephalapp Stroop task), and handgrip strength and endurance with perceived exertion ratings, alongside sleep diaries and wrist actigraphy. The primary endpoint is the pre-to post-session change in mental fatigue and cognitive performance, with secondary endpoints capturing sleep and circadian metrics, physical performance, motivation, and exam grades. Mixed-effects models will be used to test how class/exam duration, time of day, sleep quantity and quality, and chronotype relate to psychobiological responses, with the goal of informing evidence-based scheduling and workload policies in health-profession education.

This study will employ cognitive behavioral therapy for insomnia (CBT-I) among individuals with mild traumatic brain injury (mTBI) who experience sleep disturbances. The research aims to evaluate the effects of CBT-I on sleep, mTBI symptoms, and, in particular, the ability of individuals with mTBI to engage in their desired daily life activities. The main questions this study aims to answer are: 1. Does CBT-I positively impact symptoms of mTBI? 2. Does CBT-I improve functional performance in individuals with mTBI?

The JITAI approach holds considerable promise for addressing current challenges in mHealth, including the limitations in supporting real-time monitoring, timely intervention, and poor adherence. However, research on JITAIs in the field of behavioural sleep medicine is still in its infancy. Leveraging existing pilot data, this project will entail a micro-randomised trial (MRT) designed to optimise the JITAI components and a randomised controlled trial (RCT) to examine the efficacy of the optimised JITAI on sleep and circadian functions. Specifically, research has indicated that contextually tailored suggestions are more effective in promoting health behaviors compared to generic messages. This study will include personalised, in-the-moment actionable suggestions based on the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to evaluate their efficacy in contrast to generic messages and no notifications. The proposed project will have three phases. Phase I will be the technological advancement of the JITAI app, GoodShleep. Based on research findings, additional intervention engagement strategies will be added to improve adherence, including personalisation (i.e., personalised feedback and intervention content), gamification (i.e., goal setting and rewards for a completed mission), and reminders (i.e., push notifications). The refined app will be beta-tested by the research team and five individuals experiencing sleep or circadian problems to ensure the app's functionality and usability. Issues that may arise during Phase I will be resolved prior to commencing Phase II. Phase II will be an MRT aiming to optimise the advanced GoodShleep alongside wearable devices and ecological momentary assessment (EMA). A total of 77 participants with sleep or circadian problems will participate in the JITAI through the advanced GoodShleep, which will comprise (1) an 8-week, smartphone-based JITAI on TranS-C; (2) EMA prompted by push notifications to detect sleep-wake regularity and mood status; and (3) 24-hour real-time wearables assessing sleep and activity. Participants will be randomly assigned to receive contextually personalised suggestions, generic messages, and no notifications based on our micro-randomised algorithm. Phase III will involve an RCT to evaluate the optimised JITAI app, GoodShleep + in both short- (immediately after intervention) and medium-term (12 weeks after intervention). Eighty participants with sleep and circadian problems will be randomised into the optimised JITAI (GoodShleep+) and the care-as-usual (CAU) group in a 1:1 allocation ratio. The JITAI (GoodShleep) will be adjusted and finalised based on the findings from Phase II to transform into the optimised JITAI (GoodShleep+). The GoodShleep+ group will receive an 8-week, smartphone-based GoodShleep+ based on TranS-C. The CAU group will not receive the GoodShleep+ but will have access to usual care based on their needs and preferences. The CAU group will receive GoodShleep+ after completing all the assessments. Major assessments will be conducted at baseline, immediate post-intervention and 12-week follow-up. Participants' sleep conditions will be evaluated using the brief consensus sleep diary and wearables. Activity levels will be measured using wearables at multiple time points. Mood status will be assessed using selected items from PANAS-SF. Participants' weekly sleep and circadian functions will be monitored using Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) and Sleep-Related Impairment (SRI). Other outcomes will include sleep quality, anxiety and depression symptoms, sleep-related cognitions, overall daytime sleepiness, fatigue, quality of life and functional impairment. Intervention acceptability and intervention adherence will also be assessed. The current registration is only for Phase I and II of the current research project.

The JITAI approach holds considerable promise for addressing current challenges in mHealth, including the limitations in supporting real-time monitoring, timely intervention, and poor adherence. However, research on JITAIs in the field of behavioural sleep medicine is still in its infancy. Leveraging existing pilot data, this project will entail a micro-randomised trial (MRT) designed to optimise the JITAI components and a randomised controlled trial (RCT) to examine the efficacy of the optimised JITAI on sleep and circadian functions. Specifically, research has indicated that contextually tailored suggestions are more effective in promoting health behaviors compared to generic messages.This study will include personalised, in-the-moment actionable suggestions based on the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to evaluate their efficacy in contrast to generic messages and no notifications. The proposed project will have three phases. Phase I will be the technological advancement of the JITAI app, GoodShleep. Based on research findings, additional intervention engagement strategies will be added to improve adherence, including personalisation (i.e., personalised feedback and intervention content), gamification (i.e., goal setting and rewards for a completed mission), and reminders (i.e., push notifications). The refined app will be beta-tested by the research team and five individuals experiencing sleep or circadian problems to ensure the app's functionality and usability. Issues that may arise during Phase I will be resolved prior to commencing Phase II. Phase II will be an MRT aiming to optimise the advanced GoodShleep alongside wearable devices and ecological momentary assessment (EMA). A total of 77 participants with sleep or circadian problems will participate in the JITAI through the advanced GoodShleep, which will comprise (1) an 8-week, smartphone-based JITAI on TranS-C; (2) EMA prompted by push notifications to detect sleep-wake regularity and mood status; and (3) 24-hour real-time wearables assessing sleep and activity. Participants will be randomly assigned to receive contextually personalised suggestions, generic messages, and no notifications based on our micro-randomised algorithm. Phase III will involve an RCT to evaluate the optimised JITAI app, GoodShleep+ in both short- (immediately after intervention) and medium-term (12 weeks after intervention). Eighty participants with sleep and circadian problems will be randomised into the optimised JITAI (GoodShleep+) and the care-as-usual (CAU) group in a 1:1 allocation ratio. The JITAI (GoodShleep) will be adjusted and finalised based on the findings from Phase II to transform into the optimised JITAI (GoodShleep+). The GoodShleep+ group will receive an 8-week, smartphone-based GoodShleep+ based on TranS-C. The CAU group will not receive the GoodShleep+ but will have access to usual care based on their needs and preferences. The CAU group will receive GoodShleep+ after completing all the assessments. Major assessments will be conducted at baseline, immediate post-intervention and 12-week follow-up. Participants' sleep conditions will be evaluated using the brief consensus sleep diary and wearables. Activity levels will be measured using wearables at multiple time points. Mood status will be assessed using selected items from PANAS-SF. Participants' weekly sleep and circadian functions will be monitored using Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) and Sleep-Related Impairment (SRI). Other outcomes will include sleep quality, anxiety and depression symptoms, sleep-related cognitions, overall daytime sleepiness, fatigue, quality of life and functional impairment. Intervention acceptability and intervention adherence will also be assessed. The current registration is only for Phase III of the current research project.