Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep OptimizationNCT07409883
Association Between Slow Wave Activity and Sleep Inertia
An observational study of Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization and Sleep Inertia, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization, Sleep Inertia, Night Shift Work
- What is being tested?
- Nap intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 28 participants
- Where
- 1 siteThailand
- Study dates
- 4 Feb 2026to 30 Aug 2026
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers aged between 18 and 60 years, without significant sleep deprivation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Faculty of Engineering, Mahidol University
Nakhon Pathom, 73170
Pongsakorn Tanayapong, Doctor of Medicine, (66)-64-9626525, pongsakorn.taa@mahidol.ac.th
About this study
Official title: 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?
Read the detailed description
Sleepiness and fatigue are common complaints among shift workers, especially night shift workers. Napping interventions before a work shift have been reported to increase alertness and reduce accidents. However, naps may also result in impaired cognition for a brief period immediately after awakening, known as "sleep inertia", which can be particularly problematic in on-call settings and may require a worker to delay the return to work for up to about 30 minutes after waking. Although, nap duration less than 30 minutes, theoretically, may produce less intense sleep inertia. However, evidence regarding nap duration aiming to mitigate sleepiness and fatigue is mixing. We thus aimed to investigate the association between slow wave activity (SWA) assessed by EEG power spectral analysis during the last 10 minutes before awakening and 10-minute psychomotor vigilance test (PVT) immediately after awakening and 30 minutes after awakening in healthy participants on simulated night shift scenarios.
- Conditions
- Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization, Sleep Inertia, Night Shift Work
- Being tested
- Nap intervention
- Keywords
- sleep inertia, nap
- Medical subject headings
- Idiopathic Hypersomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nap interventionBehavioural
Nap intervention is the protocol that allows the participant to sleep from 11:00 PM to 2:00 AM, then woken up.
| Study group | Role | What they receive |
|---|---|---|
| Nap intervention | Not described Receives: Behavioral: Nap intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Psychomotor vigilance test (PVT) will be assessed 2 times: 1) immediately after awakening, and 2) at 30 minutes after awakening.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start4 Feb 2026 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep OptimizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Ramathibodi Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409883
- Sponsor's protocol ID
- MURA2026/53
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 22734577Achermann 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.
PubMed 8919196Hilditch CJ, McHill AW. Sleep inertia: current insights. Nat Sci Sleep. 2019 Aug 22;11:155-165. doi: 10.2147/NSS.S188911. eCollection 2019.
PubMed 31692489Tassi 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.
PubMed 16303153Dinges 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; New Collective Author. 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.
PubMed 10188130Tassi P, Muzet A. Sleep inertia. Sleep Med Rev. 2000 Aug;4(4):341-353. doi: 10.1053/smrv.2000.0098.
PubMed 12531174Patterson 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.
PubMed 34116386Lerman 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.
PubMed 22269988
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Slow Wave Activity and Sleep Inertia in Nighttime Simulated Naps: An Observational Study With Nap Intervention
- ClinicalTrials.gov ID
- NCT07409883
- Acronym / sponsor ID
- MURA2026/53
- Conditions
- Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization, Sleep Inertia, Night Shift Work
- Keywords
- sleep inertia, nap
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Ramathibodi Hospital
- Study start
- 4 Feb 2026 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Sleepiness and fatigue are common complaints among shift workers, especially night shift workers. Napping interventions before a work shift have been reported to increase alertness and reduce accidents. However, naps may also result in impaired cognition for a brief period immediately after awakening, known as "sleep inertia", which can be particularly problematic in on-call settings and may require a worker to delay the return to work for up to about 30 minutes after waking. Although, nap duration less than 30 minutes, theoretically, may produce less intense sleep inertia. However, evidence regarding nap duration aiming to mitigate sleepiness and fatigue is mixing. We thus aimed to investigate the association between slow wave activity (SWA) assessed by EEG power spectral analysis during the last 10 minutes before awakening and 10-minute psychomotor vigilance test (PVT) immediately after awakening and 30 minutes after awakening in healthy participants on simulated night shift scenarios.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nap intervention | – | Behavioral: Nap intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers aged between 18 and 60 years, without significant sleep deprivation
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nap interventionNap intervention is the protocol that allows the participant to sleep from 11:00 PM to 2:00 AM, then woken up. | Behavioural | Nap intervention |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Results publication: PubMed 22734577Signal 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.
- Results publication: PubMed 8919196Achermann 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.
- Results publication: PubMed 31692489Hilditch CJ, McHill AW. Sleep inertia: current insights. Nat Sci Sleep. 2019 Aug 22;11:155-165. doi: 10.2147/NSS.S188911. eCollection 2019.
- Results publication: PubMed 16303153Tassi 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.
- Results publicationDinges D, Orne M, Orne E. Assessing performance upon abrupt awakening from nap during quasi-continuous operations. Behavior Research Methods. 1985;17:37-45
- Results publication: PubMed 10188130Jewett ME, Wyatt JK, Ritz-De Cecco A, Khalsa SB, Dijk DJ, Czeisler CA; New Collective Author. 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.
- Results publication: PubMed 12531174Tassi P, Muzet A. Sleep inertia. Sleep Med Rev. 2000 Aug;4(4):341-353. doi: 10.1053/smrv.2000.0098.
- Results publication: PubMed 34116386Patterson 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.
- Results publication: PubMed 22269988Lerman 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization and Sleep Inertia, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 13 Feb 2026. 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 Thailand. 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?
Contact Pongsakorn Tanayapong, Doctor of Medicine ((66)-64-9626525, pongsakorn.taa@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 NCT07409883, which also lists 9 linked publications.
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 13 Feb 2026.