- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07409883
Association Between Slow Wave Activity and Sleep Inertia
Association Between Slow Wave Activity and Sleep Inertia in Nighttime Simulated Naps: An Observational Study With Nap Intervention
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?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Pongsakorn Tanayapong, Doctor of Medicine
- Phone Number: (66)-64-9626525
- Email: pongsakorn.taa@mahidol.ac.th
Study Locations
-
-
-
Nakhon Pathom, Thailand, 73170
- Faculty of Engineering, Mahidol University
-
Contact:
- Pongsakorn Tanayapong, Doctor of Medicine
- Phone Number: (66)-64-9626525
- Email: pongsakorn.taa@mahidol.ac.th
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Nap intervention
|
Nap intervention is the protocol that allows the participant to sleep from 11:00 PM to 2:00 AM, then woken up.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
psychomotor vigilance test (PVT)
Time Frame: Psychomotor vigilance test (PVT) will be assessed 2 times: 1) immediately after awakening, and 2) at 30 minutes after awakening.
|
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.
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MURA2026/53
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep Inertia
-
University of Notre DameWithdrawnStress | Sleep | Sleep Inertia
-
University of ZurichLokman Hekim Üniversitesi; Elixir PharmaceuticalsCompletedCaffeine | Placebo | Sleep InertiaSwitzerland
-
Centre Hospitalier Universitaire de NīmesRecruitingMajor Depression | Sleep InertiaFrance
-
Washington University School of MedicineRecruitingBehavior | Process, Acceptance | Inertia of AccommodationUnited States
-
Essilor InternationalRecruitingAccommodation Disorder | Accommodative Fatigue | Accommodative InertiaFrance
-
Creighton UniversityNovartisCompleted
-
Istanbul Arel UniversityRecruitingConstipation | Colonic Inertia | DyscheziaTurkey
-
Beth Israel Medical CenterWyeth is now a wholly owned subsidiary of PfizerWithdrawn
-
Centre Hospitalier Universitaire de NīmesTerminated
Clinical Trials on Nap intervention
-
Brigham and Women's HospitalTerminatedSleep Disorders, Intrinsic | Sleep Disorders, Circadian Rhythm | Advanced Sleep Phase Syndrome (ASPS) | Delayed Sleep Phase Syndrome | Shift-Work Sleep Disorder | Delayed Sleep Phase | Non-24 Hour Sleep-Wake Disorder | Advanced Sleep Phase Syndrome | Advanced Sleep Phase | Irregular Sleep-Wake Syndrome | Shift...United States
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)RecruitingShift WorkUnited States
-
University of Maryland, College ParkUniversity of Massachusetts, AmherstRecruiting
-
Duke-NUS Graduate Medical SchoolNational Medical Research Council (NMRC), SingaporeCompleted
-
Duke-NUS Graduate Medical SchoolNational Medical Research Council (NMRC), SingaporeCompleted
-
Kessler FoundationRecruitingTraumatic Brain InjuryUnited States
-
University Hospital, CaenCompleted
-
Centre Hospitalier Departemental VendeeCompleted
-
The University of Hong KongChinese University of Hong KongCompleted
-
Duke-NUS Graduate Medical SchoolNational Medical Research Council (NMRC), SingaporeCompletedSleep | Sleep RestrictionSingapore