HealthyNCT03058159
Sleep Inertia and Functional Connectivity
A study testing fMRI in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The aim of the study is to investigate the functional connectivity between the brain regions of the default mode network before and after a 40 min nap slot in the afternoon. The hypothesis is that connectivity between brain regions will be decreased after the nap as compared to before the nap. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- fMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2015to 3 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 65 > age > 18
- high or law dream recall frequency
Who cannot join
- history of psychiatric or neurologic or sleep pathologies
- counter indication for MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Inertia and Functional Connectivity Between Brain Regions at Awakening : a Functional Magnetic Resonance Imaging (fMRI) Study
The aim of the study is to investigate the functional connectivity between the brain regions of the default mode network before and after a 40 min nap slot in the afternoon. The hypothesis is that connectivity between brain regions will be decreased after the nap as compared to before the nap.
- Conditions
- Healthy
- Being tested
- fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
fMRI scans will be acquired before and after a 40 min nap slot in the afternoon. Functional connectivity between brain region will be assessed analyzing the scans with the CONN toolbox of the Statistical Parametric Mapping (SPM) software.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with a high dream recall frequency | Other | Not described Receives: Other: fMRI |
| Subjects with a law dream recall frequency | Other | Not described Receives: Other: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Change of correlation values between the BOLD (Blood Oxygenation Level Dependent) signal time series of the brain regions of the default mode network (DMN) between the scans before and after the nap slot.
The hypothesis is that connectivity between the brain regions of the default mode network will be decreased after the nap as compared to before the nap and that it will be more the case for subjects with a high dream recall frequency as compared to subjects with a law dream recall frequency. fMRI scans will be acquired before and after a 40 min nap slot in the afternoon. Functional connectivity between brain region will be assessed analyzing the scans with the functional connectivity toolbox (CONN) of the Statistical Parametric Mapping (SPM) software.
Measured: fMRI scans will be acquired 5 min before, 5 min after and 25min after the nap slot.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start5 Mar 2015
- Primary completion24 May 2017
- Study completion3 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain NICOLAS, MD, Principal investigator, CH le VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058159
- Sponsor's protocol ID
- 69HCL16_0675
- Status last verified
- Aug 2025
- First submitted
- 9 Feb 2017
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vallat R, Meunier D, Nicolas A, Ruby P. Hard to wake up? The cerebral correlates of sleep inertia assessed using combined behavioral, EEG and fMRI measures. Neuroimage. 2019 Jan 1;184:266-278. doi: 10.1016/j.neuroimage.2018.09.033. Epub 2018 Sep 14.
PubMed 30223060
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Inertia and Functional Connectivity Between Brain Regions at Awakening : a Functional Magnetic Resonance Imaging (fMRI) Study
- ClinicalTrials.gov ID
- NCT03058159
- Acronym / sponsor ID
- 69HCL16_0675
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 Mar 2015 (actual)
- Primary completion
- 24 May 2017 (actual)
- Study completion
- 3 Jul 2017 (actual)
- First posted
- 20 Feb 2017 (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.
The aim of the study is to investigate the functional connectivity between the brain regions of the default mode network before and after a 40 min nap slot in the afternoon. The hypothesis is that connectivity between brain regions will be decreased after the nap as compared to before the nap.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with a high dream recall frequency | Other | Other: fMRI |
| Subjects with a law dream recall frequency | Other | Other: fMRI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 65 > age > 18
- high or law dream recall frequency
Key exclusion criteria (2 listed)
- history of psychiatric or neurologic or sleep pathologies
- counter indication for MRI
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 |
|---|---|---|
| fMRIfMRI scans will be acquired before and after a 40 min nap slot in the afternoon. Functional connectivity between brain region will be assessed analyzing the scans with the CONN toolbox of the Statistical Parametric Mapping (SPM) software. | Other | Subjects with a high dream recall frequency, Subjects with a law dream recall frequency |
Primary outcome
Measure: Change of correlation values between the BOLD (Blood Oxygenation Level Dependent) signal time series of the brain regions of the default mode network (DMN) between the scans before and after the nap slot.
Time frame: fMRI scans will be acquired 5 min before, 5 min after and 25min after the nap slot.
The hypothesis is that connectivity between the brain regions of the default mode network will be decreased after the nap as compared to before the nap and that it will be more the case for subjects with a high dream recall frequency as compared to subjects with a law dream recall frequency. fMRI scans will be acquired before and after a 40 min nap slot in the afternoon. Functional connectivity between brain region will be assessed analyzing the scans with the functional connectivity toolbox (CONN) of the Statistical Parametric Mapping (SPM) software.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Results publication: PubMed 30223060Vallat R, Meunier D, Nicolas A, Ruby P. Hard to wake up? The cerebral correlates of sleep inertia assessed using combined behavioral, EEG and fMRI measures. Neuroimage. 2019 Jan 1;184:266-278. doi: 10.1016/j.neuroimage.2018.09.033. Epub 2018 Sep 14.
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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. This study is not recruiting at the moment.
Alain NICOLAS, MD principal investigator
CH le VINATIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 3 Sep 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure: Change of correlation values between the BOLD (Blood Oxygenation Level Dependent) signal time series of the brain regions of the default mode network (DMN) between the scans before and after the nap slot. (time frame: fMRI scans will be acquired 5 min before, 5 min after and 25min after the nap slot.). 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 NCT03058159, 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 3 Sep 2025.