Effects of Acute Sleep Deprivation on Individuals With Different APOE Genotypes

NCT ID: NCT07085754

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-08

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Sleep Sleep Deprivation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sleep Deprivation

24 hours of sleep deprivation

Group Type EXPERIMENTAL

Sleep Deprivation

Intervention Type BEHAVIORAL

Sleep deprivation for up to 24 hours with no naps or other sleep periods

Control

24 hours of a normal work-rest schedule

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sleep Deprivation

Sleep deprivation for up to 24 hours with no naps or other sleep periods

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yuhui Qiu

OTHER

Sponsor Role lead

Responsible Party

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Yuhui Qiu

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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yuhui qiu

Role: primary

Other Identifiers

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ZF2025-206-01

Identifier Type: -

Identifier Source: org_study_id