Svalöv, Sweden
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
Eligible subjects must meet the International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD). Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol titrated to either 150 mg, 300 mg, or placebo once per night shift for 12 weeks.
Phase
3Span
126 weeksSponsor
Axsome Therapeutics, Inc.Recruiting
Quantification of Phosphorylated Alpha-synuclein in Cutaneous Biopsies as a Prospective Biomarker in Parkinson's Disease
This is a prospective, longitudinal study involving 75 Parkinson's disease patients and 25 patients with REM Behavior Disorder. Each participant will undergo a baseline evaluation followed by follow-ups every six months over an 18-month period. The evaluations will include clinical assessments, neurologic exams, and skin biopsies from three locations. Data will be collected on disease progression and the amount of P-SYN in cutaneous nerve fibers.
Phase
N/ASpan
72 weeksSponsor
CND Life SciencesRecruiting
Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease
Sleep disturbances are common and understudied in established or prodromal Parkinson's disease. The purpose of this study is to systematically and comprehensively determine the clinical characteristics and electrophysiologic patterns of the major sleep disorders in PD and isolated RBD.
Phase
N/ASpan
163 weeksSponsor
Assistance Publique - Hôpitaux de ParisRecruiting
Healthy Volunteers
Sleep Disorders and Tumor Immune Microenvironment
1. Background support Sleep disorders are common in patients with lung cancer, and the incidence is as high as 52.6%-70%, which is related to tumor progression and immunosuppression. Animal experiments have shown that circadian rhythm disruption can reshape the tumor microenvironment, suppress immune responses (such as macrophage dysfunction), and lead to accelerated tumor growth. o Clinical data show that the immune status of lung cancer patients, such as PD-L1 expression, T cell infiltration level, is closely related to treatment response and survival rate. However, there is still a lack of prospective research evidence on how sleep disorders affect the progression of lung cancer by regulating the immune microenvironment. 2. Scientific hypothesis It is hypothesized that sleep disorders (e.g., insomnia, circadian rhythm disruption) affect the tumor immune microenvironment of lung cancer patients through the following mechanisms: - inhibits the activity of anti-tumor immune cells, such as CD8+ T cells and NK cells; - promotes the infiltration of immunosuppressive cells (e.g., regulatory T cells, M2 macrophages); - up-regulates the expression of proinflammatory factors (e.g., IL-6, TNF-α) and inhibits immune checkpoints (e.g., PD-L1), thereby accelerating tumor progression and reducing treatment efficacy. 2. Study design and methods 1. Study type Prospective cohort study, stratified analysis of sleep disorder group and non-sleep disorder group, followed up for 1-3 years. 2. Study subjects - Inclusion criteria: patients with newly diagnosed stage Ⅲ-Ⅳ non-small cell lung cancer (NSCLC) who had not received systemic therapy (chemotherapy, immunotherapy or radiotherapy); - Exclusion criteria: patients with serious mental illness, other malignant tumors or receiving sleep medication; - According to the Pittsburgh Sleep Quality Index (PSQI) score, PSQI≥7 were divided into sleep disorder group, PSQI<7 were divided into control group. 3. Core indicators Indicator categories Specific indicators Sleep assessment PSQI score, polysomnography (total sleep time, sleep efficiency, and number of awakenings) 10 Immunological indicators of peripheral blood: CD4+/CD8+ T cell ratio, NK cell activity, IL-6, TNF-α levels; Tumor tissue: PD-L1 expression, tumor infiltrating lymphocytes (TILs) density, macrophage polarization (M1/M2) Clinical outcomes Time to progression (TTP), overall survival (OS), response rate (ORR) Auxiliary indicators: Anxiety and Depression Scale (HADS), quality of life score (EORTC QLQ-C30) 4. Data collection and follow-up - Baseline data: demographic characteristics, tumor stage, molecular subtype (e.g., KRAS mutation status).6 - Dynamic monitoring: sleep quality, immune indicators and tumor burden (imaging) were evaluated every 3 months; - Interventions: Non-pharmacological interventions (e.g., cognitive behavioral therapy, light therapy) 2 were implemented in the sleep-disordered group, and changes in immune indicators were observed.
Phase
N/ASpan
140 weeksSponsor
Shanghai Zhongshan HospitalRecruiting
Effect of the Palatal Expansion Treatment on Reported Sleeping Disorders in Children
This comprehensive clinical study focuses on evaluating the therapeutic impact of orthodontic maxillary expansion treatment on sleep disorder assessments in children, as reported by their parents or guardians using the Pediatric Sleep Questionnaire (PSQ). Maxillary transverse constriction is a developmental disorder that can adversely affect the orofacial region, potentially influencing breathing patterns during sleep. The primary objective is to investigate whether orthodontic intervention to widen the upper jaw can lead to favorable developmental outcomes in the orofacial region and potentially alleviate sleep-related breathing disorders. The study will involve 20 patients diagnosed with transverse maxillary constriction, identified through 3D scans of their face and dentition, compared against a control group of individuals without such constriction. Before and one year after treatment, participants will undergo 3D scanning of their facial structure and dentition, complemented by the completion of PSQ questionnaires by their parents or guardians. The study's hypotheses propose that following treatment, there will be notable changes in the mid-facial region evident from 3D facial scans, an increase in palate volume as indicated by dental scans, and a moderate improvement in reported sleep disorder symptoms based on parental observations. The research methodology incorporates non-invasive 3D facial scanning technology, a methodological advancement that allows for precise assessment of facial changes pre-treatment and post-treatment. This approach contrasts with traditional 2D imaging, offering more detailed and accurate data on structural alterations. The study also highlights the utility of PSQ as a validated tool for evaluating sleep disorders in children, avoiding the need for expensive polysomnography. By utilizing advanced imaging techniques and validated questionnaires, researchers seek to objectively measure treatment outcomes and correlate them with improvements in sleep quality and respiratory function. The study will utilize specialized equipment such as the Bellus 3D facial scanner and the Audaxceph software. Ultimately, this study aims to enhance our understanding of the relationship between maxillary expansion therapy and sleep disorder improvement in children, potentially paving the way for optimized treatment protocols and improved patient outcomes sleep related breathing problems.
Phase
N/ASpan
173 weeksSponsor
University of RijekaRecruiting
Healthy Volunteers
Translation and Validation of the French Version of the Sleep Regularity Questionnaire: a New Tool to Address the the Challenge of Sleep Health
Sleep is an essential function for physical and mental health. It involves an interaction between homeostatic regulation (need for sleep in the event of deprivation) and circadian regulation (need for sleep according to day-night alternation). Democratized at the end of the 19th century, electric lighting made nocturnal activities possible, and hence the mismatch between individuals' biological and social rhythms (mismatch of rhythms, sleep irregularity, also known as social jetlag). This sleep irregularity is all the more alarming as it is growing epidemically in our societies, and can have numerous consequences on mental health (anxiety, depression), cardiometabolic health (insulin resistance), the immune system (repeated infections), functioning (driving, cognitive performance), and quality of life. To address the public health issue of sleep irregularity, it is important to be able to obtain a valid and reliable measure. The Sleep Regularity Questionnaire (SRQ) by Dzierzewski et al. addresses this health issue, but has never been translated into French. The investigators make the following assumptions: - Cronbach's alpha = 0.87 as in the English version. - a two-dimensional structure with a circadian regularity factor and a sleep continuity regularity factor will be confirmed by confirmatory factor analyses. - Convergent validity between SRQ results and actimetric measures of sleep regularity (Sleep Regularity Index, intra-individual variability). The main objective of this study was to translate and validate the French version of the Sleep Regularity Questionnaire (SRQ). The secondary objectives are to analyze the external validity (convergent and divergent) of the SRQ by calculating : - associations with sleep complaints (insomnia, somnolence), - mental health complaints (depression, anxiety), - sleep behaviors and electroencephalographic parameters (sleep architecture, fragmentation).
Phase
N/ASpan
53 weeksSponsor
University Hospital, BordeauxRecruiting
Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
Phase
4Span
51 weeksSponsor
Nanjing First Hospital, Nanjing Medical UniversityRecruiting
Parkinson's Disease Biomarker Study
Phase
N/ASpan
357 weeksSponsor
Ronald PostumaRecruiting
Healthy Volunteers
Transauricular Vagus Nerve Stimulation Improves Postoperative Sleep Disorders in Elderly Patients.
Phase
N/ASpan
80 weeksSponsor
Beijing Tiantan HospitalRecruiting
The Effect of Sequential Feeding for Circadian Rhythm and Gut Flora Rhythm in Critically Ill Patients
Phase
N/ASpan
30 weeksSponsor
Qingdao UniversityRecruiting