NCT07409883

Brief Summary

Observational study: The goal of this observational study is to learn about the association between slow wave activity before awakening and post-awakening psychomotor vigilance task in time-fixed, 2-hour, simulated night naps in healthy individuals. The main question aims to answer is: Is the quantity of slow wave activity immediately before awakening associated with post-awakening psychomotor vigilance task metrics when awakened after 2-hour nap at night?

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Feb 2026Aug 2026

First Submitted

Initial submission to the registry

January 30, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

January 30, 2026

Last Update Submit

February 6, 2026

Conditions

Keywords

sleep inertianap

Outcome Measures

Primary Outcomes (1)

  • psychomotor vigilance test (PVT)

    To investigate the association between slow wave activity (SWA) as assessed by electroencephalographic power spectral analysis during the last 10 minutes before awakening and a 10-minute psychomotor vigilance test (10-min PVT) immediately after awakening and 30 minutes after awakening in healthy participants on simulated night shifts

    Psychomotor vigilance test (PVT) will be assessed 2 times: 1) immediately after awakening, and 2) at 30 minutes after awakening.

Study Arms (1)

Nap intervention

Behavioral: Nap intervention

Interventions

Nap intervention is the protocol that allows the participant to sleep from 11:00 PM to 2:00 AM, then woken up.

Nap intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy volunteers aged between 18 and 60 years, without significant sleep deprivation

You may qualify if:

  • Age between 18 and 60 years
  • History of appropriate sleep duration at least 6 hours/night for a minimum of 2 weeks assessed by sleep diary before the trial

You may not qualify if:

  • STOP-BANG ≥3 or previous diagnosis of obstructive sleep apnea
  • Presence of restless legs syndrome as assessed with IRLSSG criteria
  • Presence of depression as assessed by HADS (Exclude participants with HADS-Depression sub-scale score ≥8 (possible depression)
  • History of irregular work hours or shift work within 2 weeks
  • Use of sedative/hypnotic medications on a regular-basis (3 days/week or above)
  • History of epilepsy and brain tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Engineering, Mahidol University

Nakhon Pathom, 73170, Thailand

Location

Related Publications (9)

  • Signal TL, van den Berg MJ, Mulrine HM, Gander PH. Duration of sleep inertia after napping during simulated night work and in extended operations. Chronobiol Int. 2012 Jul;29(6):769-79. doi: 10.3109/07420528.2012.686547.

  • Achermann P, Werth E, Dijk DJ, Borbely AA. Time course of sleep inertia after nighttime and daytime sleep episodes. Arch Ital Biol. 1995 Dec;134(1):109-19.

  • Hilditch CJ, McHill AW. Sleep inertia: current insights. Nat Sci Sleep. 2019 Aug 22;11:155-165. doi: 10.2147/NSS.S188911. eCollection 2019.

  • Tassi P, Bonnefond A, Engasser O, Hoeft A, Eschenlauer R, Muzet A. EEG spectral power and cognitive performance during sleep inertia: the effect of normal sleep duration and partial sleep deprivation. Physiol Behav. 2006 Jan 30;87(1):177-84. doi: 10.1016/j.physbeh.2005.09.017. Epub 2005 Nov 21.

  • Dinges D, Orne M, Orne E. Assessing performance upon abrupt awakening from nap during quasi-continuous operations. Behavior Research Methods. 1985;17:37-45

    RESULT
  • Jewett ME, Wyatt JK, Ritz-De Cecco A, Khalsa SB, Dijk DJ, Czeisler CA. Time course of sleep inertia dissipation in human performance and alertness. J Sleep Res. 1999 Mar;8(1):1-8. doi: 10.1111/j.1365-2869.1999.00128.x.

  • Tassi P, Muzet A. Sleep inertia. Sleep Med Rev. 2000 Aug;4(4):341-353. doi: 10.1053/smrv.2000.0098.

  • Patterson PD, Liszka MK, Mcilvaine QS, Nong L, Weaver MD, Turner RL, Platt TE, Opitz SE, Guyette FX, Martin-Gill C, Weiss LS, Buysse DJ, Callaway CW. Does the evidence support brief (</=30-mins), moderate (31-60-mins), or long duration naps (61+ mins) on the night shift? A systematic review. Sleep Med Rev. 2021 Oct;59:101509. doi: 10.1016/j.smrv.2021.101509. Epub 2021 May 19.

  • Lerman SE, Eskin E, Flower DJ, George EC, Gerson B, Hartenbaum N, Hursh SR, Moore-Ede M; American College of Occupational and Environmental Medicine Presidential Task Force on Fatigue Risk Management. Fatigue risk management in the workplace. J Occup Environ Med. 2012 Feb;54(2):231-58. doi: 10.1097/JOM.0b013e318247a3b0. No abstract available.

MeSH Terms

Conditions

Idiopathic Hypersomnia

Condition Hierarchy (Ancestors)

Disorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

Pongsakorn Tanayapong, Doctor of Medicine

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 13, 2026

Study Start

February 4, 2026

Primary Completion

April 15, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations