Sleep, Sleep Deprivation
Conditions
Brief summary
This study aims to investigate the effects of 24-hour acute sleep deprivation on plasma Alzheimer's disease biomarkers and multi-omics in individuals with different APOE genotypes, to elucidate the potential role of acute sleep deprivation in AD risk.
Detailed description
This is a randomized controlled trial designed to enroll 60 healthy volunteers. Stratified randomization will be used, with three strata defined by APOE genotype (APOE ε3/3, APOE ε4 carriers, and APOE ε2 carriers) in a 1:1:1 ratio. Within each stratum, participants will be randomly assigned in a 1:1 ratio to either the acute sleep-deprivation group or the non-acute sleep-deprivation group. The intervention will consist of 24 hours of acute sleep deprivation. The primary outcome measure is the change from baseline in plasma Aβ42 on the first day after randomization.
Interventions
BEHAVIORALSleep Deprivation
Sleep deprivation for up to 24 hours with no naps or other sleep periods
Sponsors
Yuhui Qiu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-40 years, gender not limited * Healthy (with no clinically significant abnormal findings in the physical examination report or self-reporting as healthy) and not on medications * Cognitively normal (Mini-Mental State Examination (MMSE) score \> 28) * Sleep duration of 7-9 hours per night, good sleep quality (Pittsburgh Sleep Quality Index (PSQI) ≤ 5 points) * Written informed consent, voluntarily participate in this study, and be able to cooperate with the physician to complete the clinical study
Exclusion criteria
* Presence of day-night sleep reversal * Shift work within the past 6 months * Travel across time zones or experience of jet lag within the past three weeks * Current smoking or nicotine use; alcohol consumption exceeding five standard units per week (one standard alcohol unit is defined as 10 mL \[or 8 g\] of pure alcohol) * Consumption of strong tea, coffee, or caffeine-containing foods and beverages within one week before study participation * Family history of early-onset dementia * Self-Rating Depression Scale (SDS) score ≥ 53, Self-Rating Anxiety Scale (SAS) score ≥ 50 * Female participants who are currently pregnant or breastfeeding * Individuals who need to drive or operate vehicles or machinery during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Aβ42 levels | 1 day after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma GFAP levels | 1 day after randomization | — |
| Fatigue Scale-14 | 1 day after randomization | The Fatigue Scale-14 has a minimum score of 0 and a maximum score of 33; higher scores indicate greater fatigue severity. |
| Positive and Negative Affect Schedule | 1 day after randomization | The Positive and Negative Affect Schedule comprises two subscales: Positive Affect and Negative Affect. Each subscale ranges from 10 to 50, with higher scores indicating greater accumulation of the corresponding affect. |
| N-back tasks | 1 day after randomization | N-back test, participants are required to identify target digits that match the stimuli presented N steps earlier on the screen |
| Plasma Aβ40 levels | 1 day after randomization | — |
| Plasma t-tau levels | 1 day after randomization | — |
| Plasma p-tau181 levels | 1 day after randomization | — |
| Plasma p-tau217 levels | 1 day after randomization | — |
| Plasma NfL levels | 1 day after randomization | — |
| Plasma Aβ42/Aβ40 levels | 1 day after randomization | — |
| Plasma t-tau/Aβ42 levels | 1 day after randomization | — |
| Plasma p-tau181/Aβ42 levels | 1 day after randomization | — |
| Plasma p-tau217/Aβ42 levels | 1 day after randomization | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Metabolomics | 1 day after randomization | The plasma metabolomics will be determined by Liquid Chromatography - MassSpectrometry |
| Proteomics | 1 day after randomization | The plasma proteomics will be determined by Liquid Chromatography - MassSpectrometry |
| PET/MRI | 1 day after randomization | Assessed using Positron Emission Tomography/Magnetic Resonance Imaging(PET/MRI) |
Countries
China
Outcome results
None listed