Clinical trial NCT06492109: The Peripheral Blood Multi-Omics Study on Sleep Loss
Official title: The Peripheral Blood Multi-Omics Study on the Association of Sleep Loss With Aging and Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Deprivation
Aging
Alzheimer Disease
Healthy Lifestyle
Cognitive Decline
Shift-work Disorder
Keywords: sleep loss
multi-omics
Metabolome
aging
alzheimer's disease
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Detailed description: 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 deprivation, 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 deprivation, revealing its association with aging and AD.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent form；
2. Meet the inclusion criteria for each arms.

Exclusion Criteria:

1. Failure to provide informed consent;
2. Inability to follow study procedures due to issues such as language barriers or cognitive impairment;
3. Regular use of medications that may alter the relationship between sleep and outcome variables (e.g., opioid medications, benzodiazepines, and Z drugs \[non-benzodiazepine hypnotics\]);
4. History of alcohol abuse, substance abuse, consciousness disorders, cerebrovascular disease, head injury, epilepsy, encephalitis, or other neurological disorders;
5. Diagnosis of schizophrenia, severe depression, anxiety disorders, or other severe psychiatric conditions;
6. Presence of severe arrhythmias, myocardial infarction within the last 6 months, severe pulmonary dysfunction, renal or hepatic insufficiency, severe anemia, severe gastrointestinal diseases, tumors, or other severe medical conditions.

Primary outcomes:
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: through study completion, an average of 1 month
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: through study completion, an average of 1 month
measure: Mini-Mental State Examination (MMSE)
timeFrame: through study completion, an average of 1 month
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: through study completion, an average of 1 month
measure: Transcriptomic profile
timeFrame: through study completion, an average of 1 month
measure: Metabolic profiling
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Benyan Luo
role: PRINCIPAL_INVESTIGATOR
References: