The Peripheral Blood Multi-Omics Study on Sleep Loss

NCT ID: NCT06492109

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2025-12-31

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 loss 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 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.

Conditions

Sleep Deprivation; Aging; Alzheimer Disease; Healthy Lifestyle; Cognitive Decline; Shift-work Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy participants

Overall good health, with a BMI between 17 and 26; aged between 18 and 80 years; no complaints of cognitive impairment, normal neurological examination; signed informed consent form.

Group Type: OTHER

Sleep manipulation

Intervention Type: BEHAVIORAL

This study will collect the MMSE results as a supplement to the MoCA. The sleep status of subjects will be screened using the Morningness-Eveningness Questionnaire (MEQ), Pittsburgh Sleep Quality Index (PSQI), and Epworth Sleepiness Scale (ESS).

Subjects must maintain regular sleep and diet before sample collection. Peripheral blood samples will be taken the day before, the day of, and the day after acute sleep deprivation, whether experimentally induced (controlled) or naturally occurring (passive), along with assessment scales including anxiety and depression assessments.

For chronic sleep deprivation (≥7 days), blood samples will be collected before and after the deprivation period, with anxiety, depression, and cognitive assessments.

Experimentally induced sleep deprivation takes place under controlled laboratory conditions, whereas passive sleep deprivation arises from external factors such as aging or shift work.

Patients with mild cognitive impairment (MCI)

Meets Petersen et al.'s diagnostic criteria for MCI: presence of subjective memory complaints; objective episodic memory impairment (scores on clinical memory tests falling 1-1.5 standard deviations below age- and education-adjusted norms); overall cognitive function is essentially normal, with a score of MMSE ≥ 24 indicating normal cognitive function according to the dementia screening standards specified by the Beijing Collaborative Group; CDR-global score = 0.5; daily living abilities are largely intact (capable of using public transportation, shopping, and managing finances). Does not meet the criteria for dementia according to the International Classification of Diseases, 10th edition (research version), or the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable Alzheimer's disease. Signed informed consent form.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Patients with Alzheimer's disease (AD)

Meets the NINCDS-ADRDA criteria for probable Alzheimer's disease; CDR-global score = 1; overall cognitive decline: MMSE score of 20-24; impaired daily living abilities: Activities of Daily Living (ADL) scale score \> 26. Signed informed consent form.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sleep manipulation

This study will collect the MMSE results as a supplement to the MoCA. The sleep status of subjects will be screened using the Morningness-Eveningness Questionnaire (MEQ), Pittsburgh Sleep Quality Index (PSQI), and Epworth Sleepiness Scale (ESS).

Subjects must maintain regular sleep and diet before sample collection. Peripheral blood samples will be taken the day before, the day of, and the day after acute sleep deprivation, whether experimentally induced (controlled) or naturally occurring (passive), along with assessment scales including anxiety and depression assessments.

For chronic sleep deprivation (≥7 days), blood samples will be collected before and after the deprivation period, with anxiety, depression, and cognitive assessments.

Experimentally induced sleep deprivation takes place under controlled laboratory conditions, whereas passive sleep deprivation arises from external factors such as aging or shift work.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent form；

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benyan Luo

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Benyan Luo, Prof

Role: CONTACT

luobenyan@zju.edu.cn

0571-87236537

Facility Contacts

Benyan Luo, Prof

Role: primary

0571-87236537

Other Identifiers

Multi-omics in Sleep loss

Identifier Type: -

Identifier Source: org_study_id