Finding studies
Finding studies
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Benyan Luo, Prof
CONTACT
Lead
First Affiliated Hospital of Zhejiang University
Participants meeting inclusion and exclusion criteria will include healthy subjects, MCI patients, and AD patients. General information such as age, gender, education level, medical history, family history, medication history, and surgical history will be collected. Cognitive assessments and sleep condition screenings will be conducted, with blood samples collected before and after sleep loss, and anxiety and depression scales administered. Blood samples will be processed using standardized methods for multi-omics analysis. Joint analyses with cognitive levels and sleep conditions will be performed to identify molecular biomarkers associated with age, cognitive levels, and key biological processes related to sleep loss, revealing its association with aging and AD. This study includes an intervention component, in which part of the participants will undergo controlled (active) or naturally occurred (passive) sleep manipulation (including normal sleep, sleep deprivation, and recovery sleep), as described in the arms and interventions sections. Active sleep deprivation is conducted under controlled experimental conditions, whereas passive deprivation results from natural factors such as age or shift work. Therefore, this study qualifies as a Basic Experimental Study Involving Humans (BESH), as it does not involve the administration of any medicinal product or therapeutic intervention. According to the NIH's four defining questions for BESH: 1. Does the study involve human participants? Yes. This study involves human. 2. Are the participants prospectively assigned to an intervention? Yes. Part of the participants will prospectively assigned to a sequence of controlled sleep conditions (normal sleep, sleep deprivation, and recovery sleep) to investigate related physiological responses. 3. Is the study designed to evaluate the effect of the intervention on the participants? Yes. The aim was to investigate how changes in sleep status affected peripheral blood metabolic and immune phenotypes, as well as behavioral assessments. These served as dependent variables in the analysis. 4. Is the effect being evaluated a health-related biomedical or behavioral outcome? Yes. The outcomes are health related biomedical effects relevant to understanding physiological adaptation, though not intended for clinical application or therapeutic benefit. In brief, this study involved a part of single arm, non-masked, non-randomized, basic science intervention. These sleep manipulations were transient, reversible, and/or physiologically benign procedures designed to investigate normal biological function.The metabolic and immune phenotype as well as behavioral assessment results were the primary outcome measure of the BESH intervention.
Age
18–80
Sex
ALL
Healthy volunteers
Accepted
