The Peripheral Blood Multi-Omics Study on Sleep Loss
NCT Number: NCT06492109
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sleep Deprivation|Aging|Alzheimer Disease|Healthy Lifestyle|Cognitive Decline|Shift-work Disorder
Interventions: BEHAVIORAL: Experimental sleep deprivation
Sponsor: First Affiliated Hospital of Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SCREENING
Start Date: 2024-06-20
Completion Date: 2025-12-31
Locations: The First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, 310000, China

Summary:
Sleep plays a role in cognitive processes such as memory processing, attention processing, and overall cognitive function. In recent years, the bidirectional relationship between sleep loss and aging, as well as related neurodegenerative diseases, has garnered widespread attention. Sleep disorders are a typical clinical manifestation of neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease and are closely related to the progression of these diseases. However, current research has yet to fully elucidate the physiological responses to sleep loss across different ages and cognitive levels, as well as the association and molecular basis between sleep loss, aging, and neurodegenerative diseases. This study aims to comprehensively characterize the transcriptional and metabolic changes in peripheral blood under sleep loss in populations of different ages and cognitive levels using multi-omics approaches and to preliminarily explore the role of sleep deprivation in aging and AD.

Primary Outcome Measures: Hamilton Anxiety Rating Scale (HAM-A), The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each of the 14 items contains a number of symptoms, and each group of symptoms is rated on a scale of zero to four, with four being the most severe. All of these scores are used to compute an overarching score that indicates a person's anxiety severity., through study completion, an average of 1 month|Hamilton Depression Rating Scale (HDRS), The Hamilton Depression Rating Scale (HDRS) is the most commonly used instrument for assessing symptoms of depression. It has been used in many key studies of depression and its treatment. The instrument is designed to be administered by clinicians after a structured or unstructured interview of the patient to determine their symptoms. A total score is calculated by summing the individual scores from each question.

Scores below 7 generally represent the absence or remission of depression. Scores between 7-17 represent mild depression Scores between 18-24 represent moderate depression Scores 25 and above represent severe depression, through study completion, an average of 1 month|Mini-Mental State Examination (MMSE), The Mini Mental State Examination (MMSE) is a tool that can be used to systematically and thoroughly assess mental status. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The MMSE takes only 5-10 minutes to administer and is therefore practical to use repeatedly and routinely., through study completion, an average of 1 month|Montreal Cognitive Assessment (MoCA), The Montreal Cognitive Assessment (MOCA) was initially developed as a test for mild cognitive impairment, but has also been determined to match qualities of the MMSE.80 It assesses seven areas of cognition for a total possible score of 30 points. A score of 25 or less is indicative of cognitive impairment., through study completion, an average of 1 month|Transcriptomic profile, A comprehensive transcriptomic from plasma was obtained using RNA sequencing, through study completion, an average of 1 month|Metabolic profiling, A comprehensive metabolic profile from plasma was obtained using targeted metabolomics analysis and untargeted and targeted lipidomics analysis., through study completion, an average of 1 month