How 24-hour sleep loss affects people with different APOE genes
Effects of Acute Sleep Deprivation on Individuals With Different APOE Genotypes
This will see if 24 hours without sleep changes blood Alzheimer's-related markers in healthy adults with different APOE gene types.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Guangdong Provincial Hospital of Traditional Chinese Medicine Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07085754 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 60 healthy adults aged 18–40 and stratify them by APOE genotype (ε3/3, ε4 carriers, and ε2 carriers). Within each genotype stratum participants will be randomly assigned to either 24 hours of acute sleep deprivation or to normal sleep. Blood samples will be collected before and after the intervention to measure plasma Aβ42 and a range of multi-omics biomarkers, with the primary outcome being the change in plasma Aβ42 the day after randomization. The design tests whether a single night of sleep loss produces different molecular responses depending on APOE genotype.
Who should consider this trial
Good fit: Healthy adults 18–40 years old who normally sleep 7–9 hours per night, are cognitively normal, not taking regular medications, and willing to undergo a 24-hour overnight visit and blood draws are ideal candidates.
Not a fit: People with cognitive impairment, older adults, recent shift workers or travelers, current smokers, heavy drinkers, or those on regular medications are unlikely to be eligible or to benefit from this specific protocol.
Why it matters
Potential benefit: If successful, the results could help identify how brief sleep loss affects Alzheimer's-related blood markers by genetic risk and inform targeted prevention or monitoring strategies.
How similar studies have performed: Prior short-term sleep deprivation studies have reported changes in CSF and blood Aβ and tau, but combining stratified APOE genotyping with multi-omics profiling is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guangzhou, Guangdong
- Guangdong Provincial Hospital of Chinese Medicine — Guangzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.