The Peripheral Blood Multi-Omics Study on Sleep Loss

NCT06492109 | Recruiting

• 1 other identifier: Multi-omics in Sleep loss
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

sleep loss; multi-omics; Metabolome; aging; alzheimer's disease

Outcome Measures

Primary Outcomes (7)

• 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

• Self reported scales

  Participants underwent sleep manipulations should report their physical and mental discomforts and score them.

  through study completion, an average of 1 year

Study Arms (3)

Healthy participants

OTHER

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.

Behavioral: Sleep manipulation

Patients with mild cognitive impairment (MCI)

NO INTERVENTION

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.

Patients with Alzheimer's disease (AD)

NO INTERVENTION

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.

Interventions

Sleep manipulation 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.

Healthy participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form；

You may not qualify if:

• Failure to provide informed consent;
• Inability to follow study procedures due to issues such as language barriers or cognitive impairment;
• Regular use of medications that may alter the relationship between sleep and outcome variables (e.g., opioid medications, benzodiazepines, and Z drugs \[non-benzodiazepine hypnotics\]);
• History of alcohol abuse, substance abuse, consciousness disorders, cerebrovascular disease, head injury, epilepsy, encephalitis, or other neurological disorders;
• Diagnosis of schizophrenia, severe depression, anxiety disorders, or other severe psychiatric conditions;
• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Sleep Deprivation; Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Cognition Disorders

Study Officials

• Benyan Luo

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benyan Luo, Prof

CONTACT

0571-87236537; luobenyan@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 9, 2024
• Study Start: June 20, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)