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SleepNCT07085754

Effects of Acute Sleep Deprivation on Individuals With Different APOE Genotypes

A study testing Sleep Deprivation in people with Sleep and Sleep Deprivation, run by Yuhui Qiu at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Sleep, Sleep Deprivation
What is being tested?
Sleep Deprivation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
8 Aug 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, Guangdong

    yuhui qiu, 020-81887233, doctorqiuqiu@gzucm.edu.cn

    Recruiting

Other trials in China

About this study

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.

Read the 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.

Being tested
Sleep Deprivation
Medical subject headings
Sleep Deprivation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep DeprivationBehavioural

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

Study groups in NCT07085754
Study groupRoleWhat they receive
Sleep DeprivationExperimental24 hours of sleep deprivation
Receives: Behavioral: Sleep Deprivation
ControlNo intervention24 hours of a normal work-rest schedule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma Aβ42 levels

    Measured: 1 day after randomization

Secondary outcomes (13)

  1. Plasma Aβ40 levels

    Measured: 1 day after randomization

  2. Plasma t-tau levels

    Measured: 1 day after randomization

  3. Plasma p-tau181 levels

    Measured: 1 day after randomization

  4. Plasma p-tau217 levels

    Measured: 1 day after randomization

  5. Plasma NfL levels

    Measured: 1 day after randomization

  6. Plasma GFAP levels

    Measured: 1 day after randomization

  7. Plasma Aβ42/Aβ40 levels

    Measured: 1 day after randomization

  8. Plasma t-tau/Aβ42 levels

    Measured: 1 day after randomization

  9. Plasma p-tau181/Aβ42 levels

    Measured: 1 day after randomization

  10. Plasma p-tau217/Aβ42 levels

    Measured: 1 day after randomization

  11. Fatigue Scale-14

    The Fatigue Scale-14 has a minimum score of 0 and a maximum score of 33; higher scores indicate greater fatigue severity.

    Measured: 1 day after randomization

  12. Positive and Negative Affect Schedule

    The Positive and Negative Affect Schedule comprises two subscales: Positive Affect and Negative Affect. Each subscale ranges from 10 to 50, with higher scores indicating greater accumulation of the corresponding affect.

    Measured: 1 day after randomization

  13. N-back tasks

    N-back test, participants are required to identify target digits that match the stimuli presented N steps earlier on the screen

    Measured: 1 day after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2025
  2. Study start8 Aug 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07085754
Sponsor's protocol ID
ZF2025-206-01
Status last verified
Jul 2025
First submitted
6 Jul 2025
Last updated
24 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang HJ, Liu LL, Li YH, Qiu YH, Xia X, Cai YF, Zhang SJ. Effects of acute sleep deprivation on individuals across different APOE genotypes: a randomized controlled trial protocol. Front Neurol. 2026 Sep 22;17:1805467. doi: 10.3389/fneur.2026.1805467. eCollection 2026.

    PubMed 42840968

Questions about this trial

What is this clinical trial studying?

A study testing Sleep Deprivation in people with Sleep and Sleep Deprivation, run by Yuhui Qiu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma Aβ42 levels (time frame: 1 day after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07085754, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.

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