Effects of Acute Sleep Deprivation on Individuals With Different APOE Genotypes

Yuhui Qiu

Status

Not yet enrolling

Conditions

Sleep Deprivation

Sleep

Treatments

Behavioral: Sleep Deprivation

Study type

Interventional

Funder types

Other

Identifiers

NCT07085754

ZF2025-206-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 18-40 years, gender not limited
Chinese (subjects born in China and currently settled in Chinese mainland, and their parents are of Chinese descent)
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