The Peripheral Blood Multi-Omics Study on Sleep Loss

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Signed informed consent form;

Meet the inclusion criteria for each arms.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Healthy participantsOther 1 intervention
Group B: Patients with mild cognitive impairment (MCI)No intervention 0 interventions
Group C: Patients with Alzheimer's disease (AD)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
through study completion, an average of 1 month
2

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

Time frame
through study completion, an average of 1 month
3

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.

Time frame
through study completion, an average of 1 month
4

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.

Time frame
through study completion, an average of 1 month

Secondary outcomes

Other outcomes

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