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Recruiting NCT07085754

Effects of Acute Sleep Deprivation on Individuals With Different APOE Genotypes

No phase Interventional Sleep Sleep Deprivation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sleep Deprivation.
Who it may be relevant to
Registry conditions: Sleep, Sleep Deprivation. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

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

Primary outcome measures

  • Plasma Aβ42 levels [Time frame: 1 day after randomization]
Secondary outcome measures (12)
  • Plasma Aβ40 levels [Time frame: 1 day after randomization]
  • Plasma t-tau levels [Time frame: 1 day after randomization]
  • Plasma p-tau181 levels [Time frame: 1 day after randomization]
  • Plasma p-tau217 levels [Time frame: 1 day after randomization]
  • Plasma NfL levels [Time frame: 1 day after randomization]
  • Plasma GFAP levels [Time frame: 1 day after randomization]
  • Plasma Aβ42/Aβ40 levels [Time frame: 1 day after randomization]
  • Plasma t-tau/Aβ42 levels [Time frame: 1 day after randomization]
  • Plasma p-tau181/Aβ42 levels [Time frame: 1 day after randomization]
  • Plasma p-tau217/Aβ42 levels [Time frame: 1 day after randomization]
  • Fatigue Scale-14 [Time frame: 1 day after randomization]
  • Positive and Negative Affect Schedule [Time frame: 1 day after randomization]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

China · 1 center
  • Guangdong Provincial Hospital of Chinese Medicine — Guangzhou

Identifiers

NCT: NCT07085754 · ZF2025-206-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗