Sleep DeprivationNCT06492109
The Peripheral Blood Multi-Omics Study on Sleep Loss
A study testing Sleep manipulation in people with Sleep Deprivation and Aging, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Aging, Alzheimer Disease
- What is being tested?
- Sleep manipulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent form；
- Meet the inclusion criteria for each arms.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Benyan Luo, Prof, 0571-87236537
About this study
Official title: The Peripheral Blood Multi-Omics Study on the Association of Sleep Loss With Aging and Alzheimer's Disease
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.
Read the 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:
- Does the study involve human participants? Yes. This study involves human.
- 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.
- 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.
- 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
- Being tested
- Sleep manipulation
- Keywords
- sleep loss, multi-omics, Metabolome, aging, alzheimer's disease
- Medical subject headings
- Sleep Deprivation, Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep manipulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 month
Transcriptomic profile
A comprehensive transcriptomic from plasma was obtained using RNA sequencing
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start20 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benyan Luo, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492109
- Sponsor's protocol ID
- Multi-omics in Sleep loss
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2024
- Last updated
- 31 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) is not available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Peripheral Blood Multi-Omics Study on the Association of Sleep Loss With Aging and Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06492109
- Acronym / sponsor ID
- Multi-omics in Sleep loss
- Conditions
- Sleep Deprivation, Aging, Alzheimer Disease, Healthy Lifestyle, Cognitive Decline, Shift-work Disorder
- Keywords
- sleep loss, multi-omics, Metabolome, aging, alzheimer's disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the study involve human participants? Yes. This study involves human.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Other | Behavioral: Sleep manipulationOverall 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent form；
- Meet the inclusion criteria for each arms.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep manipulationThis 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. | Behavioural | Healthy participants |
Primary outcome
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: through study completion, an average of 1 month
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.
Hamilton Depression Rating Scale (HDRS)
Time frame: through study completion, an average of 1 month
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
Mini-Mental State Examination (MMSE)
Time frame: through study completion, an average of 1 month
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.
Montreal Cognitive Assessment (MoCA)
Time frame: through study completion, an average of 1 month
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.
Transcriptomic profile
Time frame: through study completion, an average of 1 month
A comprehensive transcriptomic from plasma was obtained using RNA sequencing
Metabolic profiling
Time frame: through study completion, an average of 1 month
A comprehensive metabolic profile from plasma was obtained using targeted metabolomics analysis and untargeted and targeted lipidomics analysis.
Self reported scales
Time frame: through study completion, an average of 1 year
Participants underwent sleep manipulations should report their physical and mental discomforts and score them.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) is not available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benyan Luo principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep manipulation in people with Sleep Deprivation and Aging, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benyan Luo, Prof (0571-87236537, luobenyan@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale (HAM-A) (time frame: through study completion, an average of 1 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.