- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03058159
Sleep Inertia and Functional Connectivity
August 26, 2025 updated by: Hospices Civils de Lyon
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bron, France, 69500
- CH Le Vinatier
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 65 > age > 18
- high or law dream recall frequency
Exclusion Criteria:
- history of psychiatric or neurologic or sleep pathologies
- counter indication for MRI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Subjects with a high 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 CONN toolbox of the Statistical Parametric Mapping (SPM) software.
|
|
Other: 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 CONN toolbox of the Statistical Parametric Mapping (SPM) software.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
fMRI scans will be acquired 5 min before, 5 min after and 25min after the nap slot.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alain Nicolas, MD, CH Le Vinatier
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2015
Primary Completion (Actual)
May 24, 2017
Study Completion (Actual)
July 3, 2017
Study Registration Dates
First Submitted
February 9, 2017
First Submitted That Met QC Criteria
February 15, 2017
First Posted (Actual)
February 20, 2017
Study Record Updates
Last Update Posted (Estimated)
September 3, 2025
Last Update Submitted That Met QC Criteria
August 26, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 69HCL16_0675
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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