Effects of Acute Sleep Deprivation on Individuals With Different APOE Genotypes

NCT07085754 | Recruiting

• 1 other identifier: ZF2025-206-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Sleep Deprivation

Outcome Measures

Primary Outcomes (1)

• Plasma Aβ42 levels

  1 day after randomization

Secondary Outcomes (13)

• 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

Other Outcomes (3)

• PET/MRI

  1 day after randomization

• Proteomics

  1 day after randomization

• Metabolomics

  1 day after randomization

Study Arms (2)

Sleep Deprivation

EXPERIMENTAL

24 hours of sleep deprivation

Behavioral: Sleep Deprivation

Control

NO INTERVENTION

24 hours of a normal work-rest schedule

Interventions

Sleep Deprivation BEHAVIORAL

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

Sleep Deprivation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhui Qiu: lead

Study Sites (1)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 25, 2025
• Study Start: August 8, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)